Trials (Centre François Baclesse): Difference between revisions

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(Created page with "'''NCTID''': NCT01827943 '''Title''': Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer '''Study Summary''': In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival. '''Sponsor''': Institut Bergonié '''Intervention''': Temsirolimus '''Start Date''': 2009-06 '''Last Updated''...")
 
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=== Trials: How to participate ===
'''Contact information:''' [https://www.baclesse.fr/recherche-et-innovation/recherche-clinique/linvestigation/ Click here to access].
'''NCTID''': NCT01827943
'''NCTID''': NCT01827943
  '''Title''': Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer
  '''Title''': [[hasTrialTitle::Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer]]
  '''Study Summary''': In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival.
  '''Study Summary''': In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival.
  '''Sponsor''': Institut Bergonié
  '''Sponsor''': Institut Bergonié
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  '''Condition''': Relapsed Bladder Cancer
  '''Condition''': Relapsed Bladder Cancer
'''NCTID''': NCT01303497
'''NCTID''': NCT01303497
  '''Title''': Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas
  '''Title''': [[hasTrialTitle::Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas]]
  '''Study Summary''': Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma
  '''Study Summary''': Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma
  '''Sponsor''': Centre Oscar Lambret
  '''Sponsor''': Centre Oscar Lambret
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  '''Condition''': Angiosarcoma
  '''Condition''': Angiosarcoma
'''NCTID''': NCT02117167
'''NCTID''': NCT02117167
  '''Title''': SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients
  '''Title''': [[hasTrialTitle::SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients]]
  '''Study Summary''': Open label multicentric randomized phase II trial, using high throughput genome analysis as a therapeutic decision tool, aimed at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with a standard treatment (pemetrexed in Non-squamous patients and erlotinib in squamous cells, targeted substudy 1) as well as immunotherapy with maintenance therapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).
  '''Study Summary''': Open label multicentric randomized phase II trial, using high throughput genome analysis as a therapeutic decision tool, aimed at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with a standard treatment (pemetrexed in Non-squamous patients and erlotinib in squamous cells, targeted substudy 1) as well as immunotherapy with maintenance therapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).
  '''Sponsor''': UNICANCER
  '''Sponsor''': UNICANCER
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  '''Condition''': Non-small Cell Lung Cancer Metastatic
  '''Condition''': Non-small Cell Lung Cancer Metastatic
'''NCTID''': NCT00744900
'''NCTID''': NCT00744900
  '''Title''': Pemetrexed Plus Cisplatin for Brain Metastasis of Advanced Non - Small Cell Lung Cancer (NSCLC)
  '''Title''': [[hasTrialTitle::Pemetrexed Plus Cisplatin for Brain Metastasis of Advanced Non - Small Cell Lung Cancer (NSCLC)]]
  '''Study Summary''': NSCLC patients often have cerebral metastasis : 10% at diagnosis and 40% during disease management. Neurosurgery is not indicated in the majority of cases because of presence of several lesions in the brain, failure of primary tumor control or presence of extra-cerebral metastasis. Cerebral metastasis lead to death in 30 to 50% of these cases. Management of these patients in this situation is based on supportive care and whole-brain radiotherapy. The place of chemotherapy for patients with good performance status was discussed for a long time and it is now admitted. However, the place of new drugs such as pemetrexed, which is currently used as a second line treatment for NSCLC, needs to be further studied. It is known that pemetrexed when added to cisplatin for treatment of NSCLC provides a similar effectiveness when compared to other drugs associations commonly used in this indication. In addition, Cisplatin with Pemetrexed probably present a better safety profile. The present study is based upon the hypothesis stipulating that the association cisplatin-pemetrexed will be at least as efficient as the others association currently used for treatment of NSCLC and will present a better safety profile. The primary objective of this study is overall response rate on brain metastasis according to RECIST criteria. Secondary judgment criterias are : Overall response rate, PFS after first-line CDDP plus pemetrexed, safety profile, quality of life, neurological symptoms, overall survival. The trial will enroll up to 45 patients in this single-arm two-stage sequential phase II study with the possibility of stopping the study early because of lack of efficacy.
  '''Study Summary''': NSCLC patients often have cerebral metastasis : 10% at diagnosis and 40% during disease management. Neurosurgery is not indicated in the majority of cases because of presence of several lesions in the brain, failure of primary tumor control or presence of extra-cerebral metastasis. Cerebral metastasis lead to death in 30 to 50% of these cases. Management of these patients in this situation is based on supportive care and whole-brain radiotherapy. The place of chemotherapy for patients with good performance status was discussed for a long time and it is now admitted. However, the place of new drugs such as pemetrexed, which is currently used as a second line treatment for NSCLC, needs to be further studied. It is known that pemetrexed when added to cisplatin for treatment of NSCLC provides a similar effectiveness when compared to other drugs associations commonly used in this indication. In addition, Cisplatin with Pemetrexed probably present a better safety profile. The present study is based upon the hypothesis stipulating that the association cisplatin-pemetrexed will be at least as efficient as the others association currently used for treatment of NSCLC and will present a better safety profile. The primary objective of this study is overall response rate on brain metastasis according to RECIST criteria. Secondary judgment criterias are : Overall response rate, PFS after first-line CDDP plus pemetrexed, safety profile, quality of life, neurological symptoms, overall survival. The trial will enroll up to 45 patients in this single-arm two-stage sequential phase II study with the possibility of stopping the study early because of lack of efficacy.
  '''Sponsor''': University Hospital, Brest
  '''Sponsor''': University Hospital, Brest
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  '''Condition''': Lung Cancer
  '''Condition''': Lung Cancer
'''NCTID''': NCT01361100
'''NCTID''': NCT01361100
  '''Title''': Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract
  '''Title''': [[hasTrialTitle::Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract]]
  '''Study Summary''': This is a multicentric feasibility study aimed to evaluate the Oncoral® test. The study includes 2 steps. The first one aims to validate the algorithm defined at the time when the test was developed in patients with different tumour stages. Patients will be enrolled before any treatment. They will immediately undergo the test. No follow-up will be realized. In total, 100 patients will be included in this first step. The estimated period of inclusion is 6 months. If the algorithm is validated, the second step of the study will start. The purpose is to determine the characteristics of the test. Enrollment will concern smokers and alcohol drinkers at high risk of developing an epidermoid carcinoma of the upper aerodigestive tract. Patient follow-up will vary with both the result of the test and the biopsy, up to a maximum of one year. In total, 385 patients will be enrolled in this step during an estimated period of 18 months.
  '''Study Summary''': This is a multicentric feasibility study aimed to evaluate the Oncoral® test. The study includes 2 steps. The first one aims to validate the algorithm defined at the time when the test was developed in patients with different tumour stages. Patients will be enrolled before any treatment. They will immediately undergo the test. No follow-up will be realized. In total, 100 patients will be included in this first step. The estimated period of inclusion is 6 months. If the algorithm is validated, the second step of the study will start. The purpose is to determine the characteristics of the test. Enrollment will concern smokers and alcohol drinkers at high risk of developing an epidermoid carcinoma of the upper aerodigestive tract. Patient follow-up will vary with both the result of the test and the biopsy, up to a maximum of one year. In total, 385 patients will be enrolled in this step during an estimated period of 18 months.
  '''Sponsor''': Centre Leon Berard
  '''Sponsor''': Centre Leon Berard
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  '''Condition''': Carcinoma
  '''Condition''': Carcinoma
'''NCTID''': NCT01583322
'''NCTID''': NCT01583322
  '''Title''': Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer
  '''Title''': [[hasTrialTitle::Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer]]
  '''Study Summary''': Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy. In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing. Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib). This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin &amp; paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib).
  '''Study Summary''': Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy. In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing. Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib). This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin &amp; paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib).
  '''Sponsor''': ARCAGY/ GINECO GROUP
  '''Sponsor''': ARCAGY/ GINECO GROUP
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  '''Condition''': Ovarian Cancer
  '''Condition''': Ovarian Cancer
'''NCTID''': NCT04713514
'''NCTID''': NCT04713514
  '''Title''': OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC
  '''Title''': [[hasTrialTitle::OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC]]
  '''Study Summary''': The proposed study is an international randomized phase II, multicenter, open-label, three arms trial to assess best supportive care (BSC) vs OSE2101 and vs OSE2101 + pembrolizumab as maintenance treatment for patients with platinum sensitive relapsed ovarian cancers, previously treated with chemotherapy (regardless of the number of prior lines of platinum-based chemotherapy), bevacizumab (if eligible) and a PARP inhibitor (if eligible). Patients in Complete Response, Partial Response, or Stable Disease at the end of chemotherapy with at least 4 cycles of platinum based chemotherapy will be randomized in one of the three arms (randomization 1:1:2). They will receive one or the two study treatments or BSC until progression, or intolerance, or up to 2 years (from 1st study treatment dose).
  '''Study Summary''': The proposed study is an international randomized phase II, multicenter, open-label, three arms trial to assess best supportive care (BSC) vs OSE2101 and vs OSE2101 + pembrolizumab as maintenance treatment for patients with platinum sensitive relapsed ovarian cancers, previously treated with chemotherapy (regardless of the number of prior lines of platinum-based chemotherapy), bevacizumab (if eligible) and a PARP inhibitor (if eligible). Patients in Complete Response, Partial Response, or Stable Disease at the end of chemotherapy with at least 4 cycles of platinum based chemotherapy will be randomized in one of the three arms (randomization 1:1:2). They will receive one or the two study treatments or BSC until progression, or intolerance, or up to 2 years (from 1st study treatment dose).
  '''Sponsor''': ARCAGY/ GINECO GROUP
  '''Sponsor''': ARCAGY/ GINECO GROUP
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  '''Condition''': Platinum-sensitive Ovarian Cancer
  '''Condition''': Platinum-sensitive Ovarian Cancer
'''NCTID''': NCT05588700
'''NCTID''': NCT05588700
  '''Title''': Impact of a Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients
  '''Title''': [[hasTrialTitle::Impact of a Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients]]
  '''Study Summary''': Testicular germ cell tumor (TGCT) is the most common malignancy in men between 15 and 40 years. Although TCGT survivors have a good survival prognosis, they suffer from short- and long-term sequelae such as chronic fatigue, psychological disorders, cardiovascular toxicities and second malignancies. The benefits of physical activity (PA) during treatments have been demonstrated in cancer patients to improve quality of life (QoL) and physical fitness and to reduce fatigue. However, few PA programs have been proposed to TGCT patients and their effects on sequelae have not been assessed yet. A growing body of evidence links treatment-related alteration in the gut microbiota to sequelae of cancer survivors, including fatigue and cardiovascular toxicities. Also, PA has been known as a possible modulator of the gut microbiota composition. To date, no study has been conducted to examine how the gut microbiota and its metabolites moderate the effect of PA on fatigue and other late effects in TGCT survivors. The objectives will be to assess the impact of a PA program on fatigue and other sequelae and to investigate how the gut microbiota and its metabolites moderate the associations between PA and sequelae. We will conduct a prospective, multicenter, phase III, randomized controlled trial of a one-year supervised PA program. 236 men with metastatic TGCT and eligible for a first line of chemotherapy will be randomly assigned to either PA intervention or control arm. All patients will benefit from a connected activity tracker and PA recommendations. In the intervention arm, PA will be based on supervised sessions and motivational interviews. The primary endpoint (fatigue) will be assessed at 3 years. The trial will provide novel insights into the impact of PA on fatigue and other sequelae in TGCT survivors with understanding a potential underlying mechanism of gut microbiota. This evidence will support the development of targeted PA guidelines to improve QoL and reduce sequelae in TGCT survivors.
  '''Study Summary''': Testicular germ cell tumor (TGCT) is the most common malignancy in men between 15 and 40 years. Although TCGT survivors have a good survival prognosis, they suffer from short- and long-term sequelae such as chronic fatigue, psychological disorders, cardiovascular toxicities and second malignancies. The benefits of physical activity (PA) during treatments have been demonstrated in cancer patients to improve quality of life (QoL) and physical fitness and to reduce fatigue. However, few PA programs have been proposed to TGCT patients and their effects on sequelae have not been assessed yet. A growing body of evidence links treatment-related alteration in the gut microbiota to sequelae of cancer survivors, including fatigue and cardiovascular toxicities. Also, PA has been known as a possible modulator of the gut microbiota composition. To date, no study has been conducted to examine how the gut microbiota and its metabolites moderate the effect of PA on fatigue and other late effects in TGCT survivors. The objectives will be to assess the impact of a PA program on fatigue and other sequelae and to investigate how the gut microbiota and its metabolites moderate the associations between PA and sequelae. We will conduct a prospective, multicenter, phase III, randomized controlled trial of a one-year supervised PA program. 236 men with metastatic TGCT and eligible for a first line of chemotherapy will be randomly assigned to either PA intervention or control arm. All patients will benefit from a connected activity tracker and PA recommendations. In the intervention arm, PA will be based on supervised sessions and motivational interviews. The primary endpoint (fatigue) will be assessed at 3 years. The trial will provide novel insights into the impact of PA on fatigue and other sequelae in TGCT survivors with understanding a potential underlying mechanism of gut microbiota. This evidence will support the development of targeted PA guidelines to improve QoL and reduce sequelae in TGCT survivors.
  '''Sponsor''': Centre Leon Berard
  '''Sponsor''': Centre Leon Berard
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  '''Condition''': Metastatic Testicular Cancer
  '''Condition''': Metastatic Testicular Cancer
'''NCTID''': NCT04410185
'''NCTID''': NCT04410185
  '''Title''': Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology
  '''Title''': [[hasTrialTitle::Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology]]
  '''Study Summary''': The study is based on the realization of a meditation program associating patients, caregivers and control subjects
  '''Study Summary''': The study is based on the realization of a meditation program associating patients, caregivers and control subjects
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Cancer
  '''Condition''': Cancer
'''NCTID''': NCT04115007
'''NCTID''': NCT04115007
  '''Title''': Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients
  '''Title''': [[hasTrialTitle::Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients]]
  '''Study Summary''': INDICATION: Oligometastatic hormone-sensitive prostate cancer patients. METHODOLOGY: Open label, double arm, randomized 1:1, multicenter phase III study. PRIMARY OBJECTIVE: To assess the efficacy of ablative radiotherapy (SBRT applied to all oligometastases) administered to all gross tumor sites (metastases and prostate if applicable), in oligometastatic hormone-sensitive prostate cancer patients.
  '''Study Summary''': INDICATION: Oligometastatic hormone-sensitive prostate cancer patients. METHODOLOGY: Open label, double arm, randomized 1:1, multicenter phase III study. PRIMARY OBJECTIVE: To assess the efficacy of ablative radiotherapy (SBRT applied to all oligometastases) administered to all gross tumor sites (metastases and prostate if applicable), in oligometastatic hormone-sensitive prostate cancer patients.
  '''Sponsor''': UNICANCER
  '''Sponsor''': UNICANCER
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  '''Condition''': Oligometastatic Hormone Sensitive Prostate Cancer
  '''Condition''': Oligometastatic Hormone Sensitive Prostate Cancer
'''NCTID''': NCT02298283
'''NCTID''': NCT02298283
  '''Title''': Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD
  '''Title''': [[hasTrialTitle::Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD]]
  '''Study Summary''': This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin’s lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).
  '''Study Summary''': This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin’s lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).
  '''Sponsor''': The Lymphoma Academic Research Organisation
  '''Sponsor''': The Lymphoma Academic Research Organisation
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  '''Condition''': Hodgkin Lymphoma
  '''Condition''': Hodgkin Lymphoma
'''NCTID''': NCT00775307
'''NCTID''': NCT00775307
  '''Title''': Adjuvant Pazopanib in Stage I NSCLC
  '''Title''': [[hasTrialTitle::Adjuvant Pazopanib in Stage I NSCLC]]
  '''Study Summary''': The aim of this study is to evaluate the efficacy and safety of pazopanib compared with placebo in patients with T &lt; or = 5 cm, N0 (stage I according to TNM 2009) completely resected NSCLC.
  '''Study Summary''': The aim of this study is to evaluate the efficacy and safety of pazopanib compared with placebo in patients with T &lt; or = 5 cm, N0 (stage I according to TNM 2009) completely resected NSCLC.
  '''Sponsor''': Intergroupe Francophone de Cancerologie Thoracique
  '''Sponsor''': Intergroupe Francophone de Cancerologie Thoracique
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  '''Condition''': Carcinoma, Non-Small-Cell Lung
  '''Condition''': Carcinoma, Non-Small-Cell Lung
'''NCTID''': NCT01900743
'''NCTID''': NCT01900743
  '''Title''': Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma
  '''Title''': [[hasTrialTitle::Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma]]
  '''Study Summary''': This is an international (France, Austria and Germany), randomized, double-blind, placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS) after failure or intolerance to doxorubicin (or other anthracycline). Five cohorts will be defined: Cohort A: Liposarcoma Cohort B: Leiomyosarcoma Cohort C: Synovial sarcoma Cohort D: other sarcomas (see Appendix C) Cohort E: Leiomyosarcoma, Synovial sarcoma and other sarcomas listed in Appendix C previously treated with pazopanib Approximately 226 patients who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment groups.
  '''Study Summary''': This is an international (France, Austria and Germany), randomized, double-blind, placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS) after failure or intolerance to doxorubicin (or other anthracycline). Five cohorts will be defined: Cohort A: Liposarcoma Cohort B: Leiomyosarcoma Cohort C: Synovial sarcoma Cohort D: other sarcomas (see Appendix C) Cohort E: Leiomyosarcoma, Synovial sarcoma and other sarcomas listed in Appendix C previously treated with pazopanib Approximately 226 patients who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment groups.
  '''Sponsor''': Centre Oscar Lambret
  '''Sponsor''': Centre Oscar Lambret
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  '''Condition''': Sarcoma
  '''Condition''': Sarcoma
'''NCTID''': NCT06041607
'''NCTID''': NCT06041607
  '''Title''': Shared Meditation Involving People With Cancer, Carers and Third Parties
  '''Title''': [[hasTrialTitle::Shared Meditation Involving People With Cancer, Carers and Third Parties]]
  '''Study Summary''': Although the benefits of meditation are increasingly well documented, few hospitals offer this integrative approach in their supportive cancer care. Meditation is sometimes provided, but its potential benefits remain insufficiently evaluated. This project is based on the hypothesis that there could be a benefit in meditating together.
  '''Study Summary''': Although the benefits of meditation are increasingly well documented, few hospitals offer this integrative approach in their supportive cancer care. Meditation is sometimes provided, but its potential benefits remain insufficiently evaluated. This project is based on the hypothesis that there could be a benefit in meditating together.
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Patients With Cancer
  '''Condition''': Patients With Cancer
'''NCTID''': NCT02867033
'''NCTID''': NCT02867033
  '''Title''': National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis (ALTITUDES)
  '''Title''': [[hasTrialTitle::National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis (ALTITUDES)]]
  '''Study Summary''': The purpose of this study is to constitute the French largest Aggressive fibromatosis cohort.
  '''Study Summary''': The purpose of this study is to constitute the French largest Aggressive fibromatosis cohort.
  '''Sponsor''': Centre Oscar Lambret
  '''Sponsor''': Centre Oscar Lambret
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  '''Condition''': Aggressive Fibromatosis
  '''Condition''': Aggressive Fibromatosis
'''NCTID''': NCT01882933
'''NCTID''': NCT01882933
  '''Title''': D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma
  '''Title''': [[hasTrialTitle::D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma]]
  '''Study Summary''': A prospective, opened, multicentric, randomised, phase III trial with two arms: * Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin * Arm B: curative gastrectomy with D1-D2 lymph node dissection Main objective: Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology), treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy alone.
  '''Study Summary''': A prospective, opened, multicentric, randomised, phase III trial with two arms: * Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin * Arm B: curative gastrectomy with D1-D2 lymph node dissection Main objective: Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology), treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy alone.
  '''Sponsor''': Hospices Civils de Lyon
  '''Sponsor''': Hospices Civils de Lyon
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  '''Condition''': Gastric Adenocarcinoma
  '''Condition''': Gastric Adenocarcinoma
'''NCTID''': NCT01362933
'''NCTID''': NCT01362933
  '''Title''': National Evaluation of the Adherence to Recommendations of Venous Thrombo Embolism Treatment in Cancer Patients
  '''Title''': [[hasTrialTitle::National Evaluation of the Adherence to Recommendations of Venous Thrombo Embolism Treatment in Cancer Patients]]
  '''Study Summary''': Treatment of venous thromboembolism in cancer patients is specific and has been validated in trials that favor the use of LMWH (Low Molecular Weight Heparin) instead of VKA (Vitamin K Antagonist) treatment during 6 months. International recommendations have diffused this option.It is necessary to evaluate the compliance of physicians to this treatment by measuring the number of patients with cancer treated with long term use of LMWH.
  '''Study Summary''': Treatment of venous thromboembolism in cancer patients is specific and has been validated in trials that favor the use of LMWH (Low Molecular Weight Heparin) instead of VKA (Vitamin K Antagonist) treatment during 6 months. International recommendations have diffused this option.It is necessary to evaluate the compliance of physicians to this treatment by measuring the number of patients with cancer treated with long term use of LMWH.
  '''Sponsor''': Floralis
  '''Sponsor''': Floralis
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  '''Condition''': Neoplasms
  '''Condition''': Neoplasms
'''NCTID''': NCT02046733
'''NCTID''': NCT02046733
  '''Title''': Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease
  '''Title''': [[hasTrialTitle::Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease]]
  '''Study Summary''': Despite the fact that the majority of the patients with limited disease SCLC will respond very well to the standard treatment, a great proportion will relapse within 12 - 24 months. Several studies in patients with lung cancer suggested a possible favourable association between the increased presence of immunologically active cells in the tumour and survival. Nivolumab and ipilimumab are proteins, which help your immune system to attack and destroy cancer cells by your immune cells. Early clinical trials with nivolumab and ipilimumab have shown activity in a broad range of cancers, including SCLC. The aim of the current study is to investigate the efficacy (how well the treatment works) and tolerability (how severe the side effects are) of the standard treatment (chemotherapy and radiotherapy) alone, compared with the standard treatment followed by nivolumab and ipilimumab in patients with limited SCLC.
  '''Study Summary''': Despite the fact that the majority of the patients with limited disease SCLC will respond very well to the standard treatment, a great proportion will relapse within 12 - 24 months. Several studies in patients with lung cancer suggested a possible favourable association between the increased presence of immunologically active cells in the tumour and survival. Nivolumab and ipilimumab are proteins, which help your immune system to attack and destroy cancer cells by your immune cells. Early clinical trials with nivolumab and ipilimumab have shown activity in a broad range of cancers, including SCLC. The aim of the current study is to investigate the efficacy (how well the treatment works) and tolerability (how severe the side effects are) of the standard treatment (chemotherapy and radiotherapy) alone, compared with the standard treatment followed by nivolumab and ipilimumab in patients with limited SCLC.
  '''Sponsor''': ETOP IBCSG Partners Foundation
  '''Sponsor''': ETOP IBCSG Partners Foundation
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  '''Condition''': Limited Stage Small Cell Lung Cancer
  '''Condition''': Limited Stage Small Cell Lung Cancer
'''NCTID''': NCT04736485
'''NCTID''': NCT04736485
  '''Title''': Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT)
  '''Title''': [[hasTrialTitle::Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT)]]
  '''Study Summary''': Multicenter, open-label, non randomized, phase 2 trial in resectable gastric or gastroesophageal junction adenocarcinoma: Perioperative Treatment by Spartalizumab (PDR001) in Combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT)
  '''Study Summary''': Multicenter, open-label, non randomized, phase 2 trial in resectable gastric or gastroesophageal junction adenocarcinoma: Perioperative Treatment by Spartalizumab (PDR001) in Combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT)
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Gastric Cancer by AJCC V8 Stage
  '''Condition''': Gastric Cancer by AJCC V8 Stage
'''NCTID''': NCT04584086
'''NCTID''': NCT04584086
  '''Title''': Changes in the MRI Signal in Patients With Benign Tumors of the Brain and Meninges Treated With Proton Therapy: Impact of TEL and the Biological Dose Received
  '''Title''': [[hasTrialTitle::Changes in the MRI Signal in Patients With Benign Tumors of the Brain and Meninges Treated With Proton Therapy: Impact of TEL and the Biological Dose Received]]
  '''Study Summary''': The main objective is to detect with TESLA multiparametric 3 MRI, the MRI secondary changes to protontherapy irradiation and to correlate them with TEL mapping, physical dose and biological dose. A model should thus be able to be proposed at the end of the study.
  '''Study Summary''': The main objective is to detect with TESLA multiparametric 3 MRI, the MRI secondary changes to protontherapy irradiation and to correlate them with TEL mapping, physical dose and biological dose. A model should thus be able to be proposed at the end of the study.
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Benign Brain Tumors
  '''Condition''': Benign Brain Tumors
'''NCTID''': NCT05625087
'''NCTID''': NCT05625087
  '''Title''': Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib
  '''Title''': [[hasTrialTitle::Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib]]
  '''Study Summary''': After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was designed as a randomised, open-label, multicentre, phase II study, for comparison of alpelisib to ribociclib in combination with fulvestrant (as the continuation of the CDK4/6 inhibitor-fulvestrant strategy) in terms of progression-free survival (PFS).
  '''Study Summary''': After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was designed as a randomised, open-label, multicentre, phase II study, for comparison of alpelisib to ribociclib in combination with fulvestrant (as the continuation of the CDK4/6 inhibitor-fulvestrant strategy) in terms of progression-free survival (PFS).
  '''Sponsor''': UNICANCER
  '''Sponsor''': UNICANCER
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  '''Condition''': Breast Cancer Stage IV
  '''Condition''': Breast Cancer Stage IV
'''NCTID''': NCT02151214
'''NCTID''': NCT02151214
  '''Title''': Efficacy of Parenteral Nutrition in Patients at the Palliative Phase of Cancer.
  '''Title''': [[hasTrialTitle::Efficacy of Parenteral Nutrition in Patients at the Palliative Phase of Cancer]].
  '''Study Summary''': In malnourished patients in the palliative phase of cancer, the question is raised of the relevance of implementing artificial nutritional assistance instead of oral feeding when this is possible. Medical prescription and implementation of artificial nutrition at this stage of the illness seem less governed by data acquired by science than by subjective reasons (related to beliefs, to a cultural or religious tradition, to the symbolic role of eating, to the deeply ingrained fear of dying of hunger, to a portrayal of care, etc.) while interacting with teams, the patient and his family and relatives. And yet, the benefits/risk balance and the effect on quality of life of parenteral nutrition in a palliative situation for patients presenting with a normal alimentary tract is poorly understood. The discomfort and risks of central venous or nasogastric artificial nutrition require that the benefits of artificial nutrition be proven. The nature of these benefits relate first and foremost to the quality of life experienced by the patient in such a context. Only a controlled randomized study may lead to an optimal palliative nutritional management of undernutrition to be determined, and to inform the patient and his/her relatives clearly in order for them to express their preferences. We hypothesize that abstaining from artificial parenteral central venous nutrition and associated hydration for nutritional purposes improves quality of life without significant loss of survival compared to implementing artificial nutrition, when considered, in the absence of any specific curative treatment in anorexic patients in the palliative phase of cancer. To test this hypothesis, we propose to carry out a multicenter, prospective, controlled, randomized study in order to evaluate the efficacy of implementing parenteral nutrition compared to abstaining from doing so on the quality of life of undernourished patients in the palliative phase of cancer. The effect on overall survival and the nutritional parameters will be evaluated. The ALIM K trial will be carried out in 13 centres specializing in supportive and onco-hematology care .
  '''Study Summary''': In malnourished patients in the palliative phase of cancer, the question is raised of the relevance of implementing artificial nutritional assistance instead of oral feeding when this is possible. Medical prescription and implementation of artificial nutrition at this stage of the illness seem less governed by data acquired by science than by subjective reasons (related to beliefs, to a cultural or religious tradition, to the symbolic role of eating, to the deeply ingrained fear of dying of hunger, to a portrayal of care, etc.) while interacting with teams, the patient and his family and relatives. And yet, the benefits/risk balance and the effect on quality of life of parenteral nutrition in a palliative situation for patients presenting with a normal alimentary tract is poorly understood. The discomfort and risks of central venous or nasogastric artificial nutrition require that the benefits of artificial nutrition be proven. The nature of these benefits relate first and foremost to the quality of life experienced by the patient in such a context. Only a controlled randomized study may lead to an optimal palliative nutritional management of undernutrition to be determined, and to inform the patient and his/her relatives clearly in order for them to express their preferences. We hypothesize that abstaining from artificial parenteral central venous nutrition and associated hydration for nutritional purposes improves quality of life without significant loss of survival compared to implementing artificial nutrition, when considered, in the absence of any specific curative treatment in anorexic patients in the palliative phase of cancer. To test this hypothesis, we propose to carry out a multicenter, prospective, controlled, randomized study in order to evaluate the efficacy of implementing parenteral nutrition compared to abstaining from doing so on the quality of life of undernourished patients in the palliative phase of cancer. The effect on overall survival and the nutritional parameters will be evaluated. The ALIM K trial will be carried out in 13 centres specializing in supportive and onco-hematology care .
  '''Sponsor''': Centre Hospitalier Universitaire de Besancon
  '''Sponsor''': Centre Hospitalier Universitaire de Besancon
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  '''Condition''': Nutrition Aspect of Cancer
  '''Condition''': Nutrition Aspect of Cancer
'''NCTID''': NCT02558907
'''NCTID''': NCT02558907
  '''Title''': Comparison of MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) in Cognitive Assessment in Geriatric Oncology
  '''Title''': [[hasTrialTitle::Comparison of MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) in Cognitive Assessment in Geriatric Oncology]]
  '''Study Summary''': Compare neurocognitive testing MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) to candidates aged patients with 1st line treatment of their cancer will be received an examination oncogériatric
  '''Study Summary''': Compare neurocognitive testing MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) to candidates aged patients with 1st line treatment of their cancer will be received an examination oncogériatric
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Geriatrics
  '''Condition''': Geriatrics
'''NCTID''': NCT02947685
'''NCTID''': NCT02947685
  '''Title''': Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer
  '''Title''': [[hasTrialTitle::Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer]]
  '''Study Summary''': The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
  '''Study Summary''': The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
  '''Sponsor''': Alliance Foundation Trials, LLC.
  '''Sponsor''': Alliance Foundation Trials, LLC.
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  '''Condition''': HER-2 Positive Breast Cancer
  '''Condition''': HER-2 Positive Breast Cancer
'''NCTID''': NCT04764487
'''NCTID''': NCT04764487
  '''Title''': A Web-mediated Follow-up With the Web-application KidneyPRO Versus Standard Follow-up for Patients With Advanced Renal Cell Carcinoma Treated With Axitinib/Pembrolizumab in First Line
  '''Title''': [[hasTrialTitle::A Web-mediated Follow-up With the Web-application KidneyPRO Versus Standard Follow-up for Patients With Advanced Renal Cell Carcinoma Treated With Axitinib/Pembrolizumab in First Line]]
  '''Study Summary''': With the advent of immunotherapy, standard first-line treatment for patients with renal cell carcinoma is now an association with an immune checkpoint inhibitor. In this context, the association axitinib plus pembrolizumab has already been evaluated in several studies with positive results for Progression Free survival, Overall survival and Complete response. The combo received a positive opinion from the Committee for Medicinal Products for Human Use, and the European Commission approves the extension of Marketing Authorization in first line for metastatic renal cell carcinoma patients. In a context of treatment with a new association, it is important to manage the toxicities closely in order to allow the patients to have an optimal treatment. The underlying hypothesis is that the use of new information and communication technologies could improve clinical patient management. In this study, we wish assess the impact of monitoring via the web application KidneyPRO on the quality of life of patients with the new combination of treatment axitinib/pembrolizumab for a renal cell carcinoma in first line.
  '''Study Summary''': With the advent of immunotherapy, standard first-line treatment for patients with renal cell carcinoma is now an association with an immune checkpoint inhibitor. In this context, the association axitinib plus pembrolizumab has already been evaluated in several studies with positive results for Progression Free survival, Overall survival and Complete response. The combo received a positive opinion from the Committee for Medicinal Products for Human Use, and the European Commission approves the extension of Marketing Authorization in first line for metastatic renal cell carcinoma patients. In a context of treatment with a new association, it is important to manage the toxicities closely in order to allow the patients to have an optimal treatment. The underlying hypothesis is that the use of new information and communication technologies could improve clinical patient management. In this study, we wish assess the impact of monitoring via the web application KidneyPRO on the quality of life of patients with the new combination of treatment axitinib/pembrolizumab for a renal cell carcinoma in first line.
  '''Sponsor''': Weprom
  '''Sponsor''': Weprom
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  '''Condition''': Renal Cell Carcinoma Metastatic
  '''Condition''': Renal Cell Carcinoma Metastatic
'''NCTID''': NCT04262687
'''NCTID''': NCT04262687
  '''Title''': Chemotherapy and Immunotherapy as Treatment for MSS Metastatic Colorectal Cancer With High Immune Infiltrate
  '''Title''': [[hasTrialTitle::Chemotherapy and Immunotherapy as Treatment for MSS Metastatic Colorectal Cancer With High Immune Infiltrate]]
  '''Study Summary''': About 85% of cases of non-metastatic colorectal cancer (CRC) are related to chromosomal instability and have a proficient DNA Mismatch-Repair system (pMMR); which are also called CRC with microsatellite stability (MSS). Other CRC, i.e. 15%, are “microsatellite unstable” (MSI) with deficient DNA Mismatch-Repair system (dMMR). These latter are characterised by generation of many neo-antigens, which result in a high anti-tumour immune response and a high peri- and/or intra-tumour lymphocyte infiltration (TIL). Investigators recently showed, with a prospectively validated immune score, that 14% of localised MSS/pMMR CRC are also highly infiltrated by CD3+ lymphocytes. This same immune score has made it possible to measure high lymphocyte infiltration in hepatic metastases, in particular, in patients treated with XELOX/FOLFOX. Pembrolizumab, an anti-PD1 monoclonal antibody (programmed death-1) is an immune checkpoint inhibitor (ICI) of PD1/PD-L1 axis, recently approved in many cancers. Anti-PD1 antibodies have recently been reported as being very effective in patients with dMMR metastatic CRC (mCRC). In the study by Le DT et al. pMMR mCRC did not seem to benefit from anti-PD1 antibodies. However, it is possible that 20% of pMMR mCRC with a high CD3+ infiltrate in the tumour may be a subgroup of pMMR mCRC sensitive to ICI, as is the case for dMMR mCRC. Lastly, immunogenic cell death induced by chemotherapy, such as oxaliplatin, can increase the efficacy of ICI. The prognostic value of lymphocyte infiltrate has been demonstrated in CRC by several teams. However, no validated test is used in routine clinical practice. Previously, investigators described an automated and reproducible method for analysis of TIL and investigators validated it for clinical use. Automated tests evaluating TIL are performed on virtual slides and have showed that, out of 1,220 tumours tested, 20% were highly infiltrated by CD3+ T cells. Patients presenting with a pMMR CRC with a high immune infiltrate had a better progression-free survival (HR=0.70; p=0.02). An immunoscore® described by Galon et al. has also a high prognostic value in CRC and is based on CD3+ and CD8+ T cells infiltration in the center and periphery of the tumour. Finally, approximately 14% of tumours with a high immune infiltrate have been found in patients with metastatic CRC. Investigators formulated the hypothesis that patients with a pMMR CRC with a high immune infiltrate can be sensitive to ICI . Therefore, blocks of resected primary tumour will be collected and analysed prospectively. For each patient, slides containing tumour tissue and adjacent non-tumour tissue will be analysed using two techniques : immunoscore® and TuLIS score.It consist in Immunohistochemistry with CD3 and CD8 staining. Slides will be scanned and analysed by image analysis as previously described . Tumours will then be classified as having a “high” or “low” immune response according to type of lymphocyte infiltrate, which is independent of pre-analytic conditions. Only patients with a high immune response will be eligible for the POCHI trial. Other biomarkers will be analysed like other immune populations or mutational load. If investigators identify an immune score which seems clinically relevant to predict sensitivity to ICI in pMMR mCRC, this will make it possible to plan a randomised phase III trial comparing chemotherapy and anti-angiogenic antibody versus chemotherapy and anti-angiogenic antibody plus pembrolizumab in patients with a pMMR mCRC with a high immune score and/or a hypermutated genotype. Investigators choose PFS at 10 months as primary endpoint in POCHI trial because it is a surrogate marker of OS. Actually median PFS in first-line setting with a doublet plus a biological agent is range from 8 to 11 months in unresectable mCRC, corresponding to a PFS of 50% at 10 months. The alternative clinical hypothesis to obtain 70% of patients alive and without progression at 10 months is ambitious and currently not achieved with current chemotherapies plus a biological agent. Up until now there is no data concerning survivals outcomes of patients with a MSS mCRC with high immune infiltration score.
  '''Study Summary''': About 85% of cases of non-metastatic colorectal cancer (CRC) are related to chromosomal instability and have a proficient DNA Mismatch-Repair system (pMMR); which are also called CRC with microsatellite stability (MSS). Other CRC, i.e. 15%, are “microsatellite unstable” (MSI) with deficient DNA Mismatch-Repair system (dMMR). These latter are characterised by generation of many neo-antigens, which result in a high anti-tumour immune response and a high peri- and/or intra-tumour lymphocyte infiltration (TIL). Investigators recently showed, with a prospectively validated immune score, that 14% of localised MSS/pMMR CRC are also highly infiltrated by CD3+ lymphocytes. This same immune score has made it possible to measure high lymphocyte infiltration in hepatic metastases, in particular, in patients treated with XELOX/FOLFOX. Pembrolizumab, an anti-PD1 monoclonal antibody (programmed death-1) is an immune checkpoint inhibitor (ICI) of PD1/PD-L1 axis, recently approved in many cancers. Anti-PD1 antibodies have recently been reported as being very effective in patients with dMMR metastatic CRC (mCRC). In the study by Le DT et al. pMMR mCRC did not seem to benefit from anti-PD1 antibodies. However, it is possible that 20% of pMMR mCRC with a high CD3+ infiltrate in the tumour may be a subgroup of pMMR mCRC sensitive to ICI, as is the case for dMMR mCRC. Lastly, immunogenic cell death induced by chemotherapy, such as oxaliplatin, can increase the efficacy of ICI. The prognostic value of lymphocyte infiltrate has been demonstrated in CRC by several teams. However, no validated test is used in routine clinical practice. Previously, investigators described an automated and reproducible method for analysis of TIL and investigators validated it for clinical use. Automated tests evaluating TIL are performed on virtual slides and have showed that, out of 1,220 tumours tested, 20% were highly infiltrated by CD3+ T cells. Patients presenting with a pMMR CRC with a high immune infiltrate had a better progression-free survival (HR=0.70; p=0.02). An immunoscore® described by Galon et al. has also a high prognostic value in CRC and is based on CD3+ and CD8+ T cells infiltration in the center and periphery of the tumour. Finally, approximately 14% of tumours with a high immune infiltrate have been found in patients with metastatic CRC. Investigators formulated the hypothesis that patients with a pMMR CRC with a high immune infiltrate can be sensitive to ICI . Therefore, blocks of resected primary tumour will be collected and analysed prospectively. For each patient, slides containing tumour tissue and adjacent non-tumour tissue will be analysed using two techniques : immunoscore® and TuLIS score.It consist in Immunohistochemistry with CD3 and CD8 staining. Slides will be scanned and analysed by image analysis as previously described . Tumours will then be classified as having a “high” or “low” immune response according to type of lymphocyte infiltrate, which is independent of pre-analytic conditions. Only patients with a high immune response will be eligible for the POCHI trial. Other biomarkers will be analysed like other immune populations or mutational load. If investigators identify an immune score which seems clinically relevant to predict sensitivity to ICI in pMMR mCRC, this will make it possible to plan a randomised phase III trial comparing chemotherapy and anti-angiogenic antibody versus chemotherapy and anti-angiogenic antibody plus pembrolizumab in patients with a pMMR mCRC with a high immune score and/or a hypermutated genotype. Investigators choose PFS at 10 months as primary endpoint in POCHI trial because it is a surrogate marker of OS. Actually median PFS in first-line setting with a doublet plus a biological agent is range from 8 to 11 months in unresectable mCRC, corresponding to a PFS of 50% at 10 months. The alternative clinical hypothesis to obtain 70% of patients alive and without progression at 10 months is ambitious and currently not achieved with current chemotherapies plus a biological agent. Up until now there is no data concerning survivals outcomes of patients with a MSS mCRC with high immune infiltration score.
  '''Sponsor''': Federation Francophone de Cancerologie Digestive
  '''Sponsor''': Federation Francophone de Cancerologie Digestive
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  '''Condition''': Colorectal Cancer Metastatic
  '''Condition''': Colorectal Cancer Metastatic
'''NCTID''': NCT01358747
'''NCTID''': NCT01358747
  '''Title''': Study of a Treatment Driven by Early PET Response to a Treatment Not Monitored by Early PET in Patients With AA Stage 3-4 or 2B HL
  '''Title''': [[hasTrialTitle::Study of a Treatment Driven by Early PET Response to a Treatment Not Monitored by Early PET in Patients With AA Stage 3-4 or 2B HL]]
  '''Study Summary''': All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is hoped that patients will achieve a good response to both induction therapies consisting either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD (Adriamycine, Bléomycine, Vinblastine, Décarbazine). The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2) in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc therapy continuation to those patients who achieved only a partial response after 2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2 negative patients. For all patients included in the trial the achievement of a good response to induction treatment will be checked after four cycles of induction treatment including a centrally reviewed PET assessment Patients will be randomized after verification of eligibility and before the start of the protocol treatment.Patients will be randomly assigned to the standard treatment arm not monitored by early PET, or the experimental treatment arm driven by the PET2 result.
  '''Study Summary''': All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is hoped that patients will achieve a good response to both induction therapies consisting either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD (Adriamycine, Bléomycine, Vinblastine, Décarbazine). The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2) in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc therapy continuation to those patients who achieved only a partial response after 2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2 negative patients. For all patients included in the trial the achievement of a good response to induction treatment will be checked after four cycles of induction treatment including a centrally reviewed PET assessment Patients will be randomized after verification of eligibility and before the start of the protocol treatment.Patients will be randomly assigned to the standard treatment arm not monitored by early PET, or the experimental treatment arm driven by the PET2 result.
  '''Sponsor''': Centre Hospitalier Universitaire Dijon
  '''Sponsor''': Centre Hospitalier Universitaire Dijon
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  '''Condition''': Hodgkin’s Lymphoma
  '''Condition''': Hodgkin’s Lymphoma
'''NCTID''': NCT05102747
'''NCTID''': NCT05102747
  '''Title''': Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3''10 Gy) to the Historical Single-dose Radiosurgery (1''20 to 25 Gy) With Medico-economic Evaluation.
  '''Title''': [[hasTrialTitle::Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3''10 Gy) to the Historical Single-dose Radiosurgery (1''20 to 25 Gy) With Medico-economic Evaluation]].
  '''Study Summary''': Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of “oligometastatic” cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible. Stereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature. HSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation. Common adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment. To investigators knowledge, SRS and HSRT have not been prospectively compared.
  '''Study Summary''': Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of “oligometastatic” cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible. Stereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature. HSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation. Common adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment. To investigators knowledge, SRS and HSRT have not been prospectively compared.
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Brain Metastasis
  '''Condition''': Brain Metastasis
'''NCTID''': NCT03745950
'''NCTID''': NCT03745950
  '''Title''': UTOLA: UTerin OLAparib
  '''Title''': [[hasTrialTitle::UTOLA: UTerin OLAparib]]
  '''Study Summary''': This is a phase IIB, national, randomized, double-blinded, comparative, multi-center study, to assess the efficacy of Olaparib as maintenance after a platinum based chemotherapy in patients with Advanced or metastatic endometrial cancer
  '''Study Summary''': This is a phase IIB, national, randomized, double-blinded, comparative, multi-center study, to assess the efficacy of Olaparib as maintenance after a platinum based chemotherapy in patients with Advanced or metastatic endometrial cancer
  '''Sponsor''': ARCAGY/ GINECO GROUP
  '''Sponsor''': ARCAGY/ GINECO GROUP
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  '''Condition''': Endometrial Carcinoma
  '''Condition''': Endometrial Carcinoma
'''NCTID''': NCT04366154
'''NCTID''': NCT04366154
  '''Title''': Impact of the COVID-19 Infectious Epidemic on the Management of Oncology and Onco-hematology Patients and on the Psychological Consequences for Patients and Caregivers
  '''Title''': [[hasTrialTitle::Impact of the COVID-19 Infectious Epidemic on the Management of Oncology and Onco-hematology Patients and on the Psychological Consequences for Patients and Caregivers]]
  '''Study Summary''': This original study will assess the impact of the coronavirus health crisis on the management of patients undergoing medical treatment for cancer, in particularly on the modification of the hospital organization. It will also provide a record of the progress of patients who will have been treated during the epidemic period and infected by the virus. We will also assess the psychological impact of the pandemic in patients but also in caregivers
  '''Study Summary''': This original study will assess the impact of the coronavirus health crisis on the management of patients undergoing medical treatment for cancer, in particularly on the modification of the hospital organization. It will also provide a record of the progress of patients who will have been treated during the epidemic period and infected by the virus. We will also assess the psychological impact of the pandemic in patients but also in caregivers
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': COVID-19
  '''Condition''': COVID-19
'''NCTID''': NCT01641497
'''NCTID''': NCT01641497
  '''Title''': Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer
  '''Title''': [[hasTrialTitle::Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer]]
  '''Study Summary''': Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years with a endometrial cancer.
  '''Study Summary''': Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years with a endometrial cancer.
  '''Sponsor''': Centre Oscar Lambret
  '''Sponsor''': Centre Oscar Lambret
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  '''Condition''': Endometrial Cancer
  '''Condition''': Endometrial Cancer
'''NCTID''': NCT03301454
'''NCTID''': NCT03301454
  '''Title''': Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer
  '''Title''': [[hasTrialTitle::Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer]]
  '''Study Summary''': Phase II study, randomized, open-label, multicentric, willing to establish the benefit of pursuing chemotherapy beyond 6 weeks for non progressive patients. The study will proceed in two successive phases : * non randomized phase in which all patients will undergo chemotherapy * second phase in which only non progressive patients are going to be randomized (“discontinuation design”). Patients that will show progression in their disease during the first 6 weeks will be released of the study
  '''Study Summary''': Phase II study, randomized, open-label, multicentric, willing to establish the benefit of pursuing chemotherapy beyond 6 weeks for non progressive patients. The study will proceed in two successive phases : * non randomized phase in which all patients will undergo chemotherapy * second phase in which only non progressive patients are going to be randomized (“discontinuation design”). Patients that will show progression in their disease during the first 6 weeks will be released of the study
  '''Sponsor''': Centre Oscar Lambret
  '''Sponsor''': Centre Oscar Lambret
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  '''Condition''': Esophageal Cancer, Squamous Cell
  '''Condition''': Esophageal Cancer, Squamous Cell
'''NCTID''': NCT01850303
'''NCTID''': NCT01850303
  '''Title''': Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer
  '''Title''': [[hasTrialTitle::Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer]]
  '''Study Summary''': For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is better than monotherapy in term of overall survival and progression free survival. The current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles). After the treatment is stopped until progression and initiation of a second line treatment. The risk of this strategy is to be confronted to a rapid disease progression during the free interval. Indeed, about 1/3 of the patients whose disease was controlled after the chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of 1st line (induction chemotherapy). There is two types of maintenance : * continuous maintenance therapy which consists in continuing the treatment initially associated with platinum until disease progression. * switch maintenance which consists in introducing a new treatment after the end of induction chemotherapy The two types are validated by several trials. The marketing authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma. Gemcitabine has a good tolerance profile which make possible the use in a maintenance strategy. Several trials evaluated maintenance with this product and some show benefits in term of progression free survival. The objective of this trial is to evaluate the switch maintenance in elderly patient with a controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.
  '''Study Summary''': For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is better than monotherapy in term of overall survival and progression free survival. The current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles). After the treatment is stopped until progression and initiation of a second line treatment. The risk of this strategy is to be confronted to a rapid disease progression during the free interval. Indeed, about 1/3 of the patients whose disease was controlled after the chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of 1st line (induction chemotherapy). There is two types of maintenance : * continuous maintenance therapy which consists in continuing the treatment initially associated with platinum until disease progression. * switch maintenance which consists in introducing a new treatment after the end of induction chemotherapy The two types are validated by several trials. The marketing authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma. Gemcitabine has a good tolerance profile which make possible the use in a maintenance strategy. Several trials evaluated maintenance with this product and some show benefits in term of progression free survival. The objective of this trial is to evaluate the switch maintenance in elderly patient with a controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.
  '''Sponsor''': Intergroupe Francophone de Cancerologie Thoracique
  '''Sponsor''': Intergroupe Francophone de Cancerologie Thoracique
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  '''Condition''': Non Small Cell Lung Cancer (Squamous or Non Squamous)
  '''Condition''': Non Small Cell Lung Cancer (Squamous or Non Squamous)
'''NCTID''': NCT02271659
'''NCTID''': NCT02271659
  '''Title''': Medical and Economic Evaluation for Intermediate-risk Prostate Cancer
  '''Title''': [[hasTrialTitle::Medical and Economic Evaluation for Intermediate-risk Prostate Cancer]]
  '''Study Summary''': The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment. The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.
  '''Study Summary''': The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment. The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.
  '''Sponsor''': Hospices Civils de Lyon
  '''Sponsor''': Hospices Civils de Lyon
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  '''Condition''': Prostate Cancer
  '''Condition''': Prostate Cancer
'''NCTID''': NCT04747054
'''NCTID''': NCT04747054
  '''Title''': Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head &amp; Neck Cancers
  '''Title''': [[hasTrialTitle::Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head &amp; Neck Cancers]]
  '''Study Summary''': Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head &amp; neck cancers
  '''Study Summary''': Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head &amp; neck cancers
  '''Sponsor''': UNICANCER
  '''Sponsor''': UNICANCER
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  '''Condition''': Squamous Cell Carcinoma of Head and Neck
  '''Condition''': Squamous Cell Carcinoma of Head and Neck
'''NCTID''': NCT03169075
'''NCTID''': NCT03169075
  '''Title''': QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program
  '''Title''': [[hasTrialTitle::QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program]]
  '''Study Summary''': This phase II-III study will be randomized (2:1) patients starting first-line oral targeted therapies (OTT) for metastatic cancer between an individualized supervised physical exercise programs (SPEP) by a personal coach, and recommended physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic chemotherapy, Eastern Cooperative Oncology Group Performance status (ECOG PS) ≤2, controlled pain (visual analogue scale (VAS) &lt;3/10), and life expectancy ≥3 months.
  '''Study Summary''': This phase II-III study will be randomized (2:1) patients starting first-line oral targeted therapies (OTT) for metastatic cancer between an individualized supervised physical exercise programs (SPEP) by a personal coach, and recommended physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic chemotherapy, Eastern Cooperative Oncology Group Performance status (ECOG PS) ≤2, controlled pain (visual analogue scale (VAS) &lt;3/10), and life expectancy ≥3 months.
  '''Sponsor''': UNICANCER
  '''Sponsor''': UNICANCER
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  '''Condition''': Home Based Standardised Adapted Physical Activity Programme
  '''Condition''': Home Based Standardised Adapted Physical Activity Programme
'''NCTID''': NCT00535275
'''NCTID''': NCT00535275
  '''Title''': NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy
  '''Title''': [[hasTrialTitle::NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy]]
  '''Study Summary''': Relapses after perioperative chemotherapy and surgery
  '''Study Summary''': Relapses after perioperative chemotherapy and surgery
  '''Sponsor''': Intergroupe Francophone de Cancerologie Thoracique
  '''Sponsor''': Intergroupe Francophone de Cancerologie Thoracique
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  '''Condition''': Carcinoma, Non-Small-Cell Lung
  '''Condition''': Carcinoma, Non-Small-Cell Lung
'''NCTID''': NCT02871167
'''NCTID''': NCT02871167
  '''Title''': Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation
  '''Title''': [[hasTrialTitle::Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation]]
  '''Study Summary''': The aim of the study is to perform a French multicenter prospective interventional study in order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo cryopreservation in young women with breast cancer. The oncologic and reproductive benefit / risk ratio will be investigated in the oncology and reproductive area.
  '''Study Summary''': The aim of the study is to perform a French multicenter prospective interventional study in order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo cryopreservation in young women with breast cancer. The oncologic and reproductive benefit / risk ratio will be investigated in the oncology and reproductive area.
  '''Sponsor''': Centre Oscar Lambret
  '''Sponsor''': Centre Oscar Lambret
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  '''Condition''': Breast Cancer
  '''Condition''': Breast Cancer
'''NCTID''': NCT01564056
'''NCTID''': NCT01564056
  '''Title''': Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment
  '''Title''': [[hasTrialTitle::Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment]]
  '''Study Summary''': The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall survival for elderly patients with breast cancer, in a sub group with a high risk of relapse according to Genomic Grade test.
  '''Study Summary''': The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall survival for elderly patients with breast cancer, in a sub group with a high risk of relapse according to Genomic Grade test.
  '''Sponsor''': UNICANCER
  '''Sponsor''': UNICANCER
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  '''Condition''': Breast Cancer
  '''Condition''': Breast Cancer
'''NCTID''': NCT00651456
'''NCTID''': NCT00651456
  '''Title''': Mesothelioma Avastin Plus Pemetrexed-cisplatin Study
  '''Title''': [[hasTrialTitle::Mesothelioma Avastin Plus Pemetrexed-cisplatin Study]]
  '''Study Summary''': Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.
  '''Study Summary''': Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.
  '''Sponsor''': Intergroupe Francophone de Cancerologie Thoracique
  '''Sponsor''': Intergroupe Francophone de Cancerologie Thoracique
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  '''Condition''': Mesothelioma
  '''Condition''': Mesothelioma
'''NCTID''': NCT01844986
'''NCTID''': NCT01844986
  '''Title''': Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
  '''Title''': [[hasTrialTitle::Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy]].
  '''Study Summary''': Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
  '''Study Summary''': Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
  '''Sponsor''': AstraZeneca
  '''Sponsor''': AstraZeneca
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  '''Condition''': Newly Diagnosed
  '''Condition''': Newly Diagnosed
'''NCTID''': NCT04704219
'''NCTID''': NCT04704219
  '''Title''': Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)
  '''Title''': [[hasTrialTitle::Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)]]
  '''Study Summary''': This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma.
  '''Study Summary''': This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma.
  '''Sponsor''': Merck Sharp &amp; Dohme LLC
  '''Sponsor''': Merck Sharp &amp; Dohme LLC
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  '''Condition''': Renal Cell Carcinoma
  '''Condition''': Renal Cell Carcinoma
'''NCTID''': NCT04949256
'''NCTID''': NCT04949256
  '''Title''': Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
  '''Title''': [[hasTrialTitle::Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)]]
  '''Study Summary''': The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
  '''Study Summary''': The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
  '''Sponsor''': Merck Sharp &amp; Dohme LLC
  '''Sponsor''': Merck Sharp &amp; Dohme LLC
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  '''Condition''': Metastatic Esophageal Squamous Cell Carcinoma
  '''Condition''': Metastatic Esophageal Squamous Cell Carcinoma
'''NCTID''': NCT02383251
'''NCTID''': NCT02383251
  '''Title''': Paclitaxel/Pazopanib for Platinum Resistant/Refractory Ovarian Cancer
  '''Title''': [[hasTrialTitle::Paclitaxel/Pazopanib for Platinum Resistant/Refractory Ovarian Cancer]]
  '''Study Summary''': Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance.
  '''Study Summary''': Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance.
  '''Sponsor''': ARCAGY/ GINECO GROUP
  '''Sponsor''': ARCAGY/ GINECO GROUP
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  '''Condition''': Ovarian Cancer
  '''Condition''': Ovarian Cancer
'''NCTID''': NCT00547651
'''NCTID''': NCT00547651
  '''Title''': AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy
  '''Title''': [[hasTrialTitle::AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy]]
  '''Study Summary''': This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer.
  '''Study Summary''': This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer.
  '''Sponsor''': Celgene
  '''Sponsor''': Celgene
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  '''Condition''': Small Cell Lung Cancer
  '''Condition''': Small Cell Lung Cancer
'''NCTID''': NCT00932451
'''NCTID''': NCT00932451
  '''Title''': An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
  '''Title''': [[hasTrialTitle::An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene]]
  '''Study Summary''': This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.
  '''Study Summary''': This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.
  '''Sponsor''': Pfizer
  '''Sponsor''': Pfizer
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  '''Condition''': Carcinoma, Non-Small-Cell Lung
  '''Condition''': Carcinoma, Non-Small-Cell Lung
'''NCTID''': NCT04300556
'''NCTID''': NCT04300556
  '''Title''': A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types
  '''Title''': [[hasTrialTitle::A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types]]
  '''Study Summary''': The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer <math display="block">OC</math>, endometrial cancer <math display="block">EC</math>, non-small cell lung carcinoma <math display="block">NSCLC</math>, triple-negative breast cancer <math display="block">TNBC</math>), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A <math display="block">OC and EC participants</math> and Part B <math display="block">EC only</math>): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the use of the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days, as mitigation strategy for interstitial lung disease (ILD); and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to further evaluate the safety, tolerability and preliminary efficacy of 2 treatment regimens with farletuzumab ecteribulin (MORAb-202) in participants with advanced EC and to determine the recommended treatment regimen for further development of farletuzumab ecteribulin (MORAb-202).
  '''Study Summary''': The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer <math display="block">OC</math>, endometrial cancer <math display="block">EC</math>, non-small cell lung carcinoma <math display="block">NSCLC</math>, triple-negative breast cancer <math display="block">TNBC</math>), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A <math display="block">OC and EC participants</math> and Part B <math display="block">EC only</math>): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the use of the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days, as mitigation strategy for interstitial lung disease (ILD); and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to further evaluate the safety, tolerability and preliminary efficacy of 2 treatment regimens with farletuzumab ecteribulin (MORAb-202) in participants with advanced EC and to determine the recommended treatment regimen for further development of farletuzumab ecteribulin (MORAb-202).
  '''Sponsor''': Eisai Inc.
  '''Sponsor''': Eisai Inc.
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  '''Condition''': Solid Tumor
  '''Condition''': Solid Tumor
'''NCTID''': NCT05201547
'''NCTID''': NCT05201547
  '''Title''': Endometrial Cancer Patientes MMR Deficient Comparing Chimiotherapy vs Dostarlimab in First Line
  '''Title''': [[hasTrialTitle::Endometrial Cancer Patientes MMR Deficient Comparing Chimiotherapy vs Dostarlimab in First Line]]
  '''Study Summary''': Phase 3, randomized, multicentre study to evaluate the efficacy and safety of dostarlimab versus carboplatin-paclitaxel in patients with MMR deficient relapse or advanced endometrial cancer.
  '''Study Summary''': Phase 3, randomized, multicentre study to evaluate the efficacy and safety of dostarlimab versus carboplatin-paclitaxel in patients with MMR deficient relapse or advanced endometrial cancer.
  '''Sponsor''': ARCAGY/ GINECO GROUP
  '''Sponsor''': ARCAGY/ GINECO GROUP
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  '''Condition''': Endometrial Cancer
  '''Condition''': Endometrial Cancer
'''NCTID''': NCT01460186
'''NCTID''': NCT01460186
  '''Title''': Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer
  '''Title''': [[hasTrialTitle::Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer]]
  '''Study Summary''': This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify germ line genetic factors that influence the risk of metastatic breast cancer. 1500 patients will be enrolled in this study. Blood samples will be collected after informed consent and inclusion in the study. Patients will be treated and followed according to the standards of their treating center. They will be followed during at least 5 years every 6 months for 3 years then every year.
  '''Study Summary''': This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify germ line genetic factors that influence the risk of metastatic breast cancer. 1500 patients will be enrolled in this study. Blood samples will be collected after informed consent and inclusion in the study. Patients will be treated and followed according to the standards of their treating center. They will be followed during at least 5 years every 6 months for 3 years then every year.
  '''Sponsor''': Centre Leon Berard
  '''Sponsor''': Centre Leon Berard
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  '''Condition''': Breast Cancer
  '''Condition''': Breast Cancer
'''NCTID''': NCT02880943
'''NCTID''': NCT02880943
  '''Title''': Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL)
  '''Title''': [[hasTrialTitle::Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL)]]
  '''Study Summary''': This is a prospective, multicentre, open-label, phase I/II study to evaluate the maximum tolerated dose (MTD), and the most successful dose (MSD) of XOFIGO®, in renal cancer patients with metastases to bone, without (Group A) or with (Group B) visceral metastases.
  '''Study Summary''': This is a prospective, multicentre, open-label, phase I/II study to evaluate the maximum tolerated dose (MTD), and the most successful dose (MSD) of XOFIGO®, in renal cancer patients with metastases to bone, without (Group A) or with (Group B) visceral metastases.
  '''Sponsor''': Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
  '''Sponsor''': Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
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  '''Condition''': Clear-cell Metastatic Renal Cell Carcinoma
  '''Condition''': Clear-cell Metastatic Renal Cell Carcinoma
'''NCTID''': NCT00446225
'''NCTID''': NCT00446225
  '''Title''': Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR
  '''Title''': [[hasTrialTitle::Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR]]
  '''Study Summary''': A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK) domain of the EGFR.
  '''Study Summary''': A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK) domain of the EGFR.
  '''Sponsor''': Spanish Lung Cancer Group
  '''Sponsor''': Spanish Lung Cancer Group
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  '''Condition''': Non-Small Cell Lung Cancer
  '''Condition''': Non-Small Cell Lung Cancer
'''NCTID''': NCT05874492
'''NCTID''': NCT05874492
  '''Title''': Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Postoperative Radiotherapy for Breast Cancer
  '''Title''': [[hasTrialTitle::Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Postoperative Radiotherapy for Breast Cancer]]
  '''Study Summary''': FIBROTHERME is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial. The aim of this study is to evaluate the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis 6 months after a dermatologically oriented spa therapy in patients with severe late reactions affecting the skin and/or soft tissues at least 6 months after the end of postoperative radiotherapy for breast cancer.
  '''Study Summary''': FIBROTHERME is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial. The aim of this study is to evaluate the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis 6 months after a dermatologically oriented spa therapy in patients with severe late reactions affecting the skin and/or soft tissues at least 6 months after the end of postoperative radiotherapy for breast cancer.
  '''Sponsor''': Association Francaise pour la Recherche Thermale
  '''Sponsor''': Association Francaise pour la Recherche Thermale
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  '''Condition''': Fibrosis
  '''Condition''': Fibrosis
'''NCTID''': NCT04597125
'''NCTID''': NCT04597125
  '''Title''': Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH
  '''Title''': [[hasTrialTitle::Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH]]
  '''Study Summary''': Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer. Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain.
  '''Study Summary''': Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer. Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain.
  '''Sponsor''': Bayer
  '''Sponsor''': Bayer
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  '''Condition''': Metastatic Castrate Resistant Prostate Cancer (mCRPC)
  '''Condition''': Metastatic Castrate Resistant Prostate Cancer (mCRPC)
'''NCTID''': NCT03818386
'''NCTID''': NCT03818386
  '''Title''': Radiotherapy of Multiple Brain Metastases Using AGuIX®
  '''Title''': [[hasTrialTitle::Radiotherapy of Multiple Brain Metastases Using AGuIX®]]
  '''Study Summary''': This is a Prospective Randomized Open Blinded Endpoint phase II clinical trial. The study will be adaptive: an interim analysis is planned after enrolment of 20 patients in each arm of treatment (WBRT and AGuIX® + WBRT), to select and continue the study with group(s) that present the best response rate to the experimental treatment (AGuIX® + WBRT). The main endpoint will be evaluated by a blinded endpoint committee.
  '''Study Summary''': This is a Prospective Randomized Open Blinded Endpoint phase II clinical trial. The study will be adaptive: an interim analysis is planned after enrolment of 20 patients in each arm of treatment (WBRT and AGuIX® + WBRT), to select and continue the study with group(s) that present the best response rate to the experimental treatment (AGuIX® + WBRT). The main endpoint will be evaluated by a blinded endpoint committee.
  '''Sponsor''': University Hospital, Grenoble
  '''Sponsor''': University Hospital, Grenoble
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  '''Condition''': Brain Metastases, Adult
  '''Condition''': Brain Metastases, Adult
'''NCTID''': NCT06011525
'''NCTID''': NCT06011525
  '''Title''': Prevention of Alopecia in Patients With Localised Breast Cancer
  '''Title''': [[hasTrialTitle::Prevention of Alopecia in Patients With Localised Breast Cancer]]
  '''Study Summary''': The prevention of chemotherapy-induced alopecia (CIA) is still imperfectly managed in France. Strengthening the evidence base on the benefits of strategies to prevent CIA, based on robust methodologies, remains a prerequisite for better integration of appropriate supportive care for patients receiving chemotherapy. This research should provide new knowledge on the benefits of scalp refrigeration during anthracycline- and taxane-based chemotherapy in preventing ACI, for each of the 2 refrigeration techniques. In addition to effectiveness in preventing ACI, quality of life, self-image and satisfaction with care will be assessed by patients during and after chemotherapy. The medico-economic aspects will also be assessed for each of the two refrigeration modalities. The results of the various proposed assessments will be used to guide the choice between these two techniques for preventing ACI.
  '''Study Summary''': The prevention of chemotherapy-induced alopecia (CIA) is still imperfectly managed in France. Strengthening the evidence base on the benefits of strategies to prevent CIA, based on robust methodologies, remains a prerequisite for better integration of appropriate supportive care for patients receiving chemotherapy. This research should provide new knowledge on the benefits of scalp refrigeration during anthracycline- and taxane-based chemotherapy in preventing ACI, for each of the 2 refrigeration techniques. In addition to effectiveness in preventing ACI, quality of life, self-image and satisfaction with care will be assessed by patients during and after chemotherapy. The medico-economic aspects will also be assessed for each of the two refrigeration modalities. The results of the various proposed assessments will be used to guide the choice between these two techniques for preventing ACI.
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Chemotherapy-induced Alopecia
  '''Condition''': Chemotherapy-induced Alopecia
'''NCTID''': NCT01578655
'''NCTID''': NCT01578655
  '''Title''': Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer
  '''Title''': [[hasTrialTitle::Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer]]
  '''Study Summary''': This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms.
  '''Study Summary''': This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms.
  '''Sponsor''': Achieve Life Sciences
  '''Sponsor''': Achieve Life Sciences
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  '''Condition''': Prostate Cancer
  '''Condition''': Prostate Cancer
'''NCTID''': NCT03663725
'''NCTID''': NCT03663725
  '''Title''': Treatment Intensification With Temozolomide in Adults With a Glioblastoma
  '''Title''': [[hasTrialTitle::Treatment Intensification With Temozolomide in Adults With a Glioblastoma]]
  '''Study Summary''': Due to conflicting data on the optimal moment to start TMZ chemotherapy and the impact of prolongation of the adjuvant phase with TMZ, the ANOCEF (Association des Neuro-Oncologues d’Expression Francophone) group proposes this randomized trial comparing an intensified arm (early TMZ and extended adjuvant TMZ until toxicity, progression or patient refusal) versus the classical EORTC regimen as control (RT and concomitant TMZ started 4-6 weeks after surgery followed by a number of adjuvant TMZ cycles strictly limited to 6) for primary GBM adult patients.
  '''Study Summary''': Due to conflicting data on the optimal moment to start TMZ chemotherapy and the impact of prolongation of the adjuvant phase with TMZ, the ANOCEF (Association des Neuro-Oncologues d’Expression Francophone) group proposes this randomized trial comparing an intensified arm (early TMZ and extended adjuvant TMZ until toxicity, progression or patient refusal) versus the classical EORTC regimen as control (RT and concomitant TMZ started 4-6 weeks after surgery followed by a number of adjuvant TMZ cycles strictly limited to 6) for primary GBM adult patients.
  '''Sponsor''': Centre Oscar Lambret
  '''Sponsor''': Centre Oscar Lambret
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  '''Condition''': Glioblastoma
  '''Condition''': Glioblastoma
'''NCTID''': NCT02438007
'''NCTID''': NCT02438007
  '''Title''': A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC
  '''Title''': [[hasTrialTitle::A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC]]
  '''Study Summary''': The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).
  '''Study Summary''': The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).
  '''Sponsor''': LTN PHARMACEUTICALS, INC.
  '''Sponsor''': LTN PHARMACEUTICALS, INC.
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  '''Condition''': Prostate Cancer
  '''Condition''': Prostate Cancer
'''NCTID''': NCT02797405
'''NCTID''': NCT02797405
  '''Title''': Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay
  '''Title''': [[hasTrialTitle::Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay]]
  '''Study Summary''': THEODORA is a prospective pilot clinical trial aiming at first to evaluate and validate the predictive value of the A &amp; MS bioassays on tumor control by radiotherapy.
  '''Study Summary''': THEODORA is a prospective pilot clinical trial aiming at first to evaluate and validate the predictive value of the A &amp; MS bioassays on tumor control by radiotherapy.
  '''Sponsor''': Centre Leon Berard
  '''Sponsor''': Centre Leon Berard
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  '''Condition''': Sarcoma
  '''Condition''': Sarcoma
'''NCTID''': NCT05241405
'''NCTID''': NCT05241405
  '''Title''': Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer
  '''Title''': [[hasTrialTitle::Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer]]
  '''Study Summary''': This is a multicenter randomized trial in breast cancer patients reporting cancer-related fatigue to evaluate the efficacy and safety of Qiseng® based on extract of American ginseng combined with vitamin C from extract of Camu Camu berries
  '''Study Summary''': This is a multicenter randomized trial in breast cancer patients reporting cancer-related fatigue to evaluate the efficacy and safety of Qiseng® based on extract of American ginseng combined with vitamin C from extract of Camu Camu berries
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Breast Cancer
  '''Condition''': Breast Cancer
'''NCTID''': NCT01206205
'''NCTID''': NCT01206205
  '''Title''': Frontline Therapy in de Novo Multiple Myeloma Patients Under 65
  '''Title''': [[hasTrialTitle::Frontline Therapy in de Novo Multiple Myeloma Patients Under 65]]
  '''Study Summary''': The purpose of this Phase 2 study is to evaluate the efficacy and safety of treatment with bortezomib, lenalidomide and dexamethasone in patients with untreated multiple myeloma. This study will evaluate whether the addition of lenalidomide to bortezomib and dexamethasone will increase the Complete Response (CR)/ very good partial response (VGPR) rate before and after High Dose Therapy (HDT) with ASCT.
  '''Study Summary''': The purpose of this Phase 2 study is to evaluate the efficacy and safety of treatment with bortezomib, lenalidomide and dexamethasone in patients with untreated multiple myeloma. This study will evaluate whether the addition of lenalidomide to bortezomib and dexamethasone will increase the Complete Response (CR)/ very good partial response (VGPR) rate before and after High Dose Therapy (HDT) with ASCT.
  '''Sponsor''': University Hospital, Toulouse
  '''Sponsor''': University Hospital, Toulouse
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  '''Condition''': Multiple Myeloma
  '''Condition''': Multiple Myeloma
'''NCTID''': NCT03473652
'''NCTID''': NCT03473652
  '''Title''': Feasibility of Adapted Physical Activity Based on a Walking Platform in Hospitalized Old Patients for Cancer
  '''Title''': [[hasTrialTitle::Feasibility of Adapted Physical Activity Based on a Walking Platform in Hospitalized Old Patients for Cancer]]
  '''Study Summary''': The investigator propose to evaluate the interest of the provision of a suitable treadmill offering fall protection and verticalization assistance.
  '''Study Summary''': The investigator propose to evaluate the interest of the provision of a suitable treadmill offering fall protection and verticalization assistance.
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Oncology
  '''Condition''': Oncology
'''NCTID''': NCT02323568
'''NCTID''': NCT02323568
  '''Title''': Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs.
  '''Title''': [[hasTrialTitle::Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs]].
  '''Study Summary''': This project is part of a large multicenter multidisciplinary program that will thoroughly explore the needs and difficulties of patients with BCR as well as those involved in their care. The results of this research program will propose recommendations for better structure and understand the follow up of these patients. From the limited data in the literature, the long-term remission in patients with ovarian cancer reported a significant and persistent fatigue, poor QoL, disorders of sexuality as well as somatic and mental illness; consumption is also a medical records for these patients. In this context, our team has initiated a large case-control study to assess fatigue (identified major problem in the long-term remission in patients with ovarian cancer), QoL and rehabilitation of patients in remission from an epithelial ovarian cancer (regardless of the stage of cancer at diagnosis, early or advanced) 3 years after the initial treatment, compared with women of the same age without ovarian cancer or serious chronic disease , from the general population. Patients and controls complement standardized and validated self-administered questionnaire (part 1). This study investigated 215 patients in long remission from ovarian cancer compared to 215 women of the same age without cancer. Recruitment of patients is currently underway, in close collaboration with teams from the Group GINECO very involved in this project. Following this step, an additional component is planned: it is to offer patients who participated in part 1, a specific gynecological consultation to assess in detail the effects of the treatments in order to better meet the needs of patients .dropoff window
  '''Study Summary''': This project is part of a large multicenter multidisciplinary program that will thoroughly explore the needs and difficulties of patients with BCR as well as those involved in their care. The results of this research program will propose recommendations for better structure and understand the follow up of these patients. From the limited data in the literature, the long-term remission in patients with ovarian cancer reported a significant and persistent fatigue, poor QoL, disorders of sexuality as well as somatic and mental illness; consumption is also a medical records for these patients. In this context, our team has initiated a large case-control study to assess fatigue (identified major problem in the long-term remission in patients with ovarian cancer), QoL and rehabilitation of patients in remission from an epithelial ovarian cancer (regardless of the stage of cancer at diagnosis, early or advanced) 3 years after the initial treatment, compared with women of the same age without ovarian cancer or serious chronic disease , from the general population. Patients and controls complement standardized and validated self-administered questionnaire (part 1). This study investigated 215 patients in long remission from ovarian cancer compared to 215 women of the same age without cancer. Recruitment of patients is currently underway, in close collaboration with teams from the Group GINECO very involved in this project. Following this step, an additional component is planned: it is to offer patients who participated in part 1, a specific gynecological consultation to assess in detail the effects of the treatments in order to better meet the needs of patients .dropoff window
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Epithelial Ovarian Cancer
  '''Condition''': Epithelial Ovarian Cancer
'''NCTID''': NCT03324282
'''NCTID''': NCT03324282
  '''Title''': First-line Gemcitabine/Cisplatin +/- Avelumab in Locally Advanced or Metastatic Bladder Carcinoma
  '''Title''': [[hasTrialTitle::First-line Gemcitabine/Cisplatin +/- Avelumab in Locally Advanced or Metastatic Bladder Carcinoma]]
  '''Study Summary''': This study will assess efficacy (based on response rate) and safety (based on grade ≥ 3 severe adverse effects) of the combination Gemcitabine Cisplatin (GC) + anti-PD-L1 (avelumab) in first-line treatment for locally advanced or metastatic urothelial bladder cancer patients, after 6 cycles of treatment (or at 18 weeks if less than 6 cycles have been given, or earlier if a second line treatment is needed, before this new anticancer treatment has been started).
  '''Study Summary''': This study will assess efficacy (based on response rate) and safety (based on grade ≥ 3 severe adverse effects) of the combination Gemcitabine Cisplatin (GC) + anti-PD-L1 (avelumab) in first-line treatment for locally advanced or metastatic urothelial bladder cancer patients, after 6 cycles of treatment (or at 18 weeks if less than 6 cycles have been given, or earlier if a second line treatment is needed, before this new anticancer treatment has been started).
  '''Sponsor''': University Hospital, Bordeaux
  '''Sponsor''': University Hospital, Bordeaux
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  '''Condition''': Bladder Carcinoma
  '''Condition''': Bladder Carcinoma
'''NCTID''': NCT00397345
'''NCTID''': NCT00397345
  '''Title''': TroVax Renal Immunotherapy Survival Trial
  '''Title''': [[hasTrialTitle::TroVax Renal Immunotherapy Survival Trial]]
  '''Study Summary''': The purpose of this study is to investigate whether TroVax, when added to first line standard of care therapy, improves survival for patients with locally advanced or metastatic clear cell renal adenocarcinoma.
  '''Study Summary''': The purpose of this study is to investigate whether TroVax, when added to first line standard of care therapy, improves survival for patients with locally advanced or metastatic clear cell renal adenocarcinoma.
  '''Sponsor''': Oxford BioMedica
  '''Sponsor''': Oxford BioMedica
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  '''Condition''': Clear Cell Renal Carcinoma
  '''Condition''': Clear Cell Renal Carcinoma
'''NCTID''': NCT03752216
'''NCTID''': NCT03752216
  '''Title''': NIraparib and Quality Of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib.
  '''Title''': [[hasTrialTitle::NIraparib and Quality Of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib]].
  '''Study Summary''': This is a longitudinal, national, open, multi-centre phase IV study which will recruit up to 141 patients with ovarian cancer in late relapse treated with niraparib according to the labelling In France.
  '''Study Summary''': This is a longitudinal, national, open, multi-centre phase IV study which will recruit up to 141 patients with ovarian cancer in late relapse treated with niraparib according to the labelling In France.
  '''Sponsor''': ARCAGY/ GINECO GROUP
  '''Sponsor''': ARCAGY/ GINECO GROUP
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  '''Condition''': Ovarian Cancer
  '''Condition''': Ovarian Cancer
'''NCTID''': NCT06036706
'''NCTID''': NCT06036706
  '''Title''': Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma:
  '''Title''': [[hasTrialTitle::Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma]]
  '''Study Summary''': For the purpose of this research, investigator will constitute several cohorts of patients, treated either by intensity-modulated radiotherapy, stereotactic radiotherapy or proton-therapy. This will allow better understanding the cognitive and anatomical damages caused by new radiotherapy techniques and better understanding how ionising radiation (X-rays or protons) acts in the long term on brain tissue. Longitudinal follow-up will be multimodal, based on yearly multi-parametric brain MRI to assess morphological changes, in relation with dosimetric data as well as neuropsychological performances, health-related quality of life, anxiety and depression disorders, memory tasks, and socio-professional reintegration. This will notably make it possible to evaluate the relationship between dosimetric data, age at the time of treatment, region of the brain irradiated, type of radiation used, dose per fraction, neurocognitive and neuro-anatomical consequences. A Normal Tissue Control Probability (NTCP) model will be also developed. Overall, the results of this study should contribute to the improvement of treatment techniques, in particular by preserving as much as possible the significant cerebral zones (hippocampi, frontal lobe, sub-ventricular zones, etc.), and to the management of patients by proposing appropriate support measures. In the proton-therapy cohort, evaluations will make it possible to establish more precisely the place that this new irradiation strategy should occupy in the management of low grade meningioma. Importantly, investigator have planned to constitute a last cohort, with subjects free of any neurological disease, to make it easier the interpretation of cognitive performances over time among patients in the three brain radiation cohorts.
  '''Study Summary''': For the purpose of this research, investigator will constitute several cohorts of patients, treated either by intensity-modulated radiotherapy, stereotactic radiotherapy or proton-therapy. This will allow better understanding the cognitive and anatomical damages caused by new radiotherapy techniques and better understanding how ionising radiation (X-rays or protons) acts in the long term on brain tissue. Longitudinal follow-up will be multimodal, based on yearly multi-parametric brain MRI to assess morphological changes, in relation with dosimetric data as well as neuropsychological performances, health-related quality of life, anxiety and depression disorders, memory tasks, and socio-professional reintegration. This will notably make it possible to evaluate the relationship between dosimetric data, age at the time of treatment, region of the brain irradiated, type of radiation used, dose per fraction, neurocognitive and neuro-anatomical consequences. A Normal Tissue Control Probability (NTCP) model will be also developed. Overall, the results of this study should contribute to the improvement of treatment techniques, in particular by preserving as much as possible the significant cerebral zones (hippocampi, frontal lobe, sub-ventricular zones, etc.), and to the management of patients by proposing appropriate support measures. In the proton-therapy cohort, evaluations will make it possible to establish more precisely the place that this new irradiation strategy should occupy in the management of low grade meningioma. Importantly, investigator have planned to constitute a last cohort, with subjects free of any neurological disease, to make it easier the interpretation of cognitive performances over time among patients in the three brain radiation cohorts.
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Meningioma
  '''Condition''': Meningioma
'''NCTID''': NCT04348045
'''NCTID''': NCT04348045
  '''Title''': Phase II Study to Evaluate MAintenance Therapy With Olaparib or Selumetinib Plus Durvalumab According to BRCAness and KRAS Somatic Status Personalized in Metastatic Pancreatic Adenocarcinoma Patients
  '''Title''': [[hasTrialTitle::Phase II Study to Evaluate MAintenance Therapy With Olaparib or Selumetinib Plus Durvalumab According to BRCAness and KRAS Somatic Status Personalized in Metastatic Pancreatic Adenocarcinoma Patients]]
  '''Study Summary''': MAZEPPA is open-label, phase II study to assess the efficacy of a genomic-driven maintenance therapy in terms of PFS in Pancreatic ductal adenocarcinoma (PDAC) patients with disease controlled after 4 months of mFOLFIRINOX chemotherapy as following: Patients with a BRCAness somatic profile: olaparib Arm A. Patients with no BRCAness profile and with KRAS mutation randomization between durvalumab plus selumetinib Arm B, versus FOLFIRI Arm C.
  '''Study Summary''': MAZEPPA is open-label, phase II study to assess the efficacy of a genomic-driven maintenance therapy in terms of PFS in Pancreatic ductal adenocarcinoma (PDAC) patients with disease controlled after 4 months of mFOLFIRINOX chemotherapy as following: Patients with a BRCAness somatic profile: olaparib Arm A. Patients with no BRCAness profile and with KRAS mutation randomization between durvalumab plus selumetinib Arm B, versus FOLFIRI Arm C.
  '''Sponsor''': GERCOR - Multidisciplinary Oncology Cooperative Group
  '''Sponsor''': GERCOR - Multidisciplinary Oncology Cooperative Group
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  '''Condition''': Metastatic Pancreatic Adenocarcinoma
  '''Condition''': Metastatic Pancreatic Adenocarcinoma
'''NCTID''': NCT02730416
'''NCTID''': NCT02730416
  '''Title''': Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer
  '''Title''': [[hasTrialTitle::Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer]]
  '''Study Summary''': This study will evaluate the role of addition of an anti-angiogenic agent (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance treatment in primary advanced or with first relapse of endometrial cancer.
  '''Study Summary''': This study will evaluate the role of addition of an anti-angiogenic agent (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance treatment in primary advanced or with first relapse of endometrial cancer.
  '''Sponsor''': Nordic Society of Gynaecological Oncology - Clinical Trials Unit
  '''Sponsor''': Nordic Society of Gynaecological Oncology - Clinical Trials Unit
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  '''Condition''': Endometrial Cancer
  '''Condition''': Endometrial Cancer
'''NCTID''': NCT01613482
'''NCTID''': NCT01613482
  '''Title''': TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention
  '''Title''': [[hasTrialTitle::TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention]]
  '''Study Summary''': Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.
  '''Study Summary''': Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.
  '''Sponsor''': Centre Oscar Lambret
  '''Sponsor''': Centre Oscar Lambret
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  '''Condition''': Breast Cancer
  '''Condition''': Breast Cancer
'''NCTID''': NCT04547504
'''NCTID''': NCT04547504
  '''Title''': PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 %
  '''Title''': [[hasTrialTitle::PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 %]]
  '''Study Summary''': PERSEE is a French national phase 3 academic study comparing the chemotherapy-pembrolizumab combination to pembrolizumab alone as a first-line treatment for advanced NSCLC molecularly defined by a PDL1 expression ≥ 50% of tumour cells and no EGFR mutations or ALK rearrangement. The main hypothesis is the superiority of the chemo-immunotherapy combination over mono-immunotherapy in terms of progression-free survival evaluated by an independent review committee. One of the anticipated benefits of using the chemotherapy-pembrolizumab combination starting from the first line setting for NSCLC patients with PD L1 ≥ 50% is a reduced risk of early progression, which is known to occur with pembrolizumab monotherapy, and therefore, a better PFS.
  '''Study Summary''': PERSEE is a French national phase 3 academic study comparing the chemotherapy-pembrolizumab combination to pembrolizumab alone as a first-line treatment for advanced NSCLC molecularly defined by a PDL1 expression ≥ 50% of tumour cells and no EGFR mutations or ALK rearrangement. The main hypothesis is the superiority of the chemo-immunotherapy combination over mono-immunotherapy in terms of progression-free survival evaluated by an independent review committee. One of the anticipated benefits of using the chemotherapy-pembrolizumab combination starting from the first line setting for NSCLC patients with PD L1 ≥ 50% is a reduced risk of early progression, which is known to occur with pembrolizumab monotherapy, and therefore, a better PFS.
  '''Sponsor''': University Hospital, Brest
  '''Sponsor''': University Hospital, Brest
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  '''Condition''': Non-small-cell Lung Cancer
  '''Condition''': Non-small-cell Lung Cancer
'''NCTID''': NCT02364206
'''NCTID''': NCT02364206
  '''Title''': Study of LY2228820 With Radiotherapy Plus Concomitant TMZ in the Treatment of Newly Diagnosed Glioblastoma
  '''Title''': [[hasTrialTitle::Study of LY2228820 With Radiotherapy Plus Concomitant TMZ in the Treatment of Newly Diagnosed Glioblastoma]]
  '''Study Summary''': Glioblastomas are extremely resistant to treatment, including radiotherapy and/or chemotherapy. Mitogen-activated protein kinase (MAPK) cascades are key signaling pathways involved in the regulation of normal cell proliferation, survival and differentiation. Activation of p38 MAPK has been associated with a poor prognosis among patients with glioblastoma during the temozolomide (TMZ) era and represents a compensatory response by tumor cell to environmental stress such as radiation or chemotherapy. LY2228820 is a potent and selective inhibitor of p38 MAPK, and reduces phosphorylation of its cellular target, MAPK-activated protein kinase 2 (MAPKAPK-2) . LY2228820 is a good candidate to target malignant glioma resistance to the gold standard treatment combining radiation and TMZ by acting on both tumor and stromal cells. The primary objectives of this study were to determine the recommended dose of LY2228820 in combination with TMZ and radiotherapy during chemoradiotherapy period (phase I) and to estimate the 6-month progression free survival (PFS) rate of patients treated with LY2228820 when administered at the recommended dose in combination with radiotherapy and concomitant TMZ (phase II)
  '''Study Summary''': Glioblastomas are extremely resistant to treatment, including radiotherapy and/or chemotherapy. Mitogen-activated protein kinase (MAPK) cascades are key signaling pathways involved in the regulation of normal cell proliferation, survival and differentiation. Activation of p38 MAPK has been associated with a poor prognosis among patients with glioblastoma during the temozolomide (TMZ) era and represents a compensatory response by tumor cell to environmental stress such as radiation or chemotherapy. LY2228820 is a potent and selective inhibitor of p38 MAPK, and reduces phosphorylation of its cellular target, MAPK-activated protein kinase 2 (MAPKAPK-2) . LY2228820 is a good candidate to target malignant glioma resistance to the gold standard treatment combining radiation and TMZ by acting on both tumor and stromal cells. The primary objectives of this study were to determine the recommended dose of LY2228820 in combination with TMZ and radiotherapy during chemoradiotherapy period (phase I) and to estimate the 6-month progression free survival (PFS) rate of patients treated with LY2228820 when administered at the recommended dose in combination with radiotherapy and concomitant TMZ (phase II)
  '''Sponsor''': Centre Jean Perrin
  '''Sponsor''': Centre Jean Perrin
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  '''Condition''': Adult Glioblastoma
  '''Condition''': Adult Glioblastoma
'''NCTID''': NCT03670927
'''NCTID''': NCT03670927
  '''Title''': Etiosarc: Environmental Aetiology of Sarcomas From a Multicenter French Population-based Case-control Study Among Adults
  '''Title''': [[hasTrialTitle::Etiosarc: Environmental Aetiology of Sarcomas From a Multicenter French Population-based Case-control Study Among Adults]]
  '''Study Summary''': Introduction: Sarcomas are rare tumors of connective tissue. The exact overall incidence of sarcomas is unknown due to diagnostic difficulties and the various histological subtypes (over 80 subtypes). However, the apparent increasing incidence of sarcomas suggests environmental causes such as pesticides. Except for some specific factors (i.e. ionizing radiation, vinyl chloride, dioxin, and genetic predispositions) the scientific knowledge on the aetiology of sarcomas is sparse and inconsistent. France is a particularly appropriate country to set up a study investigating the causes of sarcoma occurrence due to the French organization in treatment and care of sarcoma patients, which is highly structured and revolved around national expert networks. The main objective of the ETIOSARC project is to study the role of lifestyle, environmental and occupational factors in the occurrence of sarcomas among adults from a multicentric population-based case-control study. Methods and analysis: Cases will be all incident cases (older than 18 years old) identified in 15 districts of France covered by a cancer registry and/or a reference center in sarcoma’s patient care over a three-year period with an inclusion start date ranging from the 1st October 2018 to the 1st January 2020 and histologically confirmed by a second review of the diagnosis. Two controls will be individually-matched by sex, age (5-years group), and districts of residence and randomly selected from electoral list. A standardized questionnaire will be administered by a trained interviewer in order to gather information about occupational and residential history, demographic and socioeconomic characteristics and lifestyle factors. At the end of the interview, a saliva sample will be systematically proposed. This study will permit to validate or not already suspected risk factors for sarcomas such as phenoxyherbicides, chlorophenol and to generate new hypothesis to increase our understanding about the genetic and environmental contributions in the carcinogenicity process.
  '''Study Summary''': Introduction: Sarcomas are rare tumors of connective tissue. The exact overall incidence of sarcomas is unknown due to diagnostic difficulties and the various histological subtypes (over 80 subtypes). However, the apparent increasing incidence of sarcomas suggests environmental causes such as pesticides. Except for some specific factors (i.e. ionizing radiation, vinyl chloride, dioxin, and genetic predispositions) the scientific knowledge on the aetiology of sarcomas is sparse and inconsistent. France is a particularly appropriate country to set up a study investigating the causes of sarcoma occurrence due to the French organization in treatment and care of sarcoma patients, which is highly structured and revolved around national expert networks. The main objective of the ETIOSARC project is to study the role of lifestyle, environmental and occupational factors in the occurrence of sarcomas among adults from a multicentric population-based case-control study. Methods and analysis: Cases will be all incident cases (older than 18 years old) identified in 15 districts of France covered by a cancer registry and/or a reference center in sarcoma’s patient care over a three-year period with an inclusion start date ranging from the 1st October 2018 to the 1st January 2020 and histologically confirmed by a second review of the diagnosis. Two controls will be individually-matched by sex, age (5-years group), and districts of residence and randomly selected from electoral list. A standardized questionnaire will be administered by a trained interviewer in order to gather information about occupational and residential history, demographic and socioeconomic characteristics and lifestyle factors. At the end of the interview, a saliva sample will be systematically proposed. This study will permit to validate or not already suspected risk factors for sarcomas such as phenoxyherbicides, chlorophenol and to generate new hypothesis to increase our understanding about the genetic and environmental contributions in the carcinogenicity process.
  '''Sponsor''': Institut National de la Santé Et de la Recherche Médicale, France
  '''Sponsor''': Institut National de la Santé Et de la Recherche Médicale, France
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  '''Condition''': Sarcoma
  '''Condition''': Sarcoma
'''NCTID''': NCT01710605
'''NCTID''': NCT01710605
  '''Title''': Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers
  '''Title''': [[hasTrialTitle::Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers]]
  '''Study Summary''': The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (CTC) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of treatment will be decided by clinicians, taking into account the criteria usually used in this setting. In the CTC arm, the type of treatment will be decided by CTC count: hormone-therapy if &lt;5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the progression-free survival: 994 patients are needed, and will be accrued in French cancer centers. Secondary clinical objectives are to compare toxicity, quality of life and overall survival between the two arms. The medico-economic study will compare cost per progression-free life years gained of the two strategies. The financial impact of centralized (one platform) vs decentralized (several platforms) CTC testing will be evaluated.
  '''Study Summary''': The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (CTC) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of treatment will be decided by clinicians, taking into account the criteria usually used in this setting. In the CTC arm, the type of treatment will be decided by CTC count: hormone-therapy if &lt;5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the progression-free survival: 994 patients are needed, and will be accrued in French cancer centers. Secondary clinical objectives are to compare toxicity, quality of life and overall survival between the two arms. The medico-economic study will compare cost per progression-free life years gained of the two strategies. The financial impact of centralized (one platform) vs decentralized (several platforms) CTC testing will be evaluated.
  '''Sponsor''': Institut Curie
  '''Sponsor''': Institut Curie
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  '''Condition''': Ductal Infiltrating Metastatic Breast Cancer
  '''Condition''': Ductal Infiltrating Metastatic Breast Cancer
'''NCTID''': NCT03652493
'''NCTID''': NCT03652493
  '''Title''': Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway
  '''Title''': [[hasTrialTitle::Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway]]
  '''Study Summary''': The investigators propose a phase II study to evaluate the efficacy of carboplatin monotherapy in the tumor subgroup of metastatic castration-resistant prostatic carcinomas with somatic abnormality in the Homologous Recombination (HR) pathway. This study may also better characterize the molecular abnormalities of tumors required for the carboplatin response
  '''Study Summary''': The investigators propose a phase II study to evaluate the efficacy of carboplatin monotherapy in the tumor subgroup of metastatic castration-resistant prostatic carcinomas with somatic abnormality in the Homologous Recombination (HR) pathway. This study may also better characterize the molecular abnormalities of tumors required for the carboplatin response
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Castration-resistant Prostate Cancer
  '''Condition''': Castration-resistant Prostate Cancer
'''NCTID''': NCT03410693
'''NCTID''': NCT03410693
  '''Title''': Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma
  '''Title''': [[hasTrialTitle::Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma]]
  '''Study Summary''': This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.
  '''Study Summary''': This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.
  '''Sponsor''': Bayer
  '''Sponsor''': Bayer
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  '''Condition''': Carcinoma, Transitional Cell
  '''Condition''': Carcinoma, Transitional Cell
'''NCTID''': NCT00932893
'''NCTID''': NCT00932893
  '''Title''': An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
  '''Title''': [[hasTrialTitle::An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene]]
  '''Study Summary''': This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.
  '''Study Summary''': This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.
  '''Sponsor''': Pfizer
  '''Sponsor''': Pfizer
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  '''Condition''': Carcinoma, Non-Small-Cell Lung
  '''Condition''': Carcinoma, Non-Small-Cell Lung
'''NCTID''': NCT05617963
'''NCTID''': NCT05617963
  '''Title''': Durvalumab Maintenance After Thoracic Chemoradiotherapy in Frail Small Cell Lung Cancer Patients Whose Disease is Limited to the Thorax
  '''Title''': [[hasTrialTitle::Durvalumab Maintenance After Thoracic Chemoradiotherapy in Frail Small Cell Lung Cancer Patients Whose Disease is Limited to the Thorax]]
  '''Study Summary''': This study is an academic-lead, open-label, multicenter, randomized phase II trial for frail limited disease Small Cell Lung Cancer (LD-SCLC) patients. Frail conditions are: Eastern Cooperative Oncology Group performance status (ECOG PS) 2 or ECOG PS 0-1 and older than 70 or ECOG PS 0-1 and did not receive a concomitant thoracic chemo-radiotherapy (CRT) because of comorbidities. During the screening phase, patients complete either the standard concomitant thoracic CRT and cisplatin-etoposide regimen or a sequential CRT and carboplatin. Patients showing a disease control (defined as stable disease <math display="block">SD</math>, partial response <math display="block">PR</math>, or complete response <math display="block">CR</math> according to RECIST v1.1) at the radiological evaluation performed after the end of thoracic CRT can receive prophylactic cranial irradiation (PCI) as per local practice. They will then be randomized to receive durvalumab every 4 weeks (experimental arm A) or surveillance (control arm B) as per standard of care. Thus, DURVALUNG study aims to evaluate the efficacy of durvalumab maintenance treatment in frail LD-SCLC patients who have not progressed following platinum-based concomitant or sequential CRT.
  '''Study Summary''': This study is an academic-lead, open-label, multicenter, randomized phase II trial for frail limited disease Small Cell Lung Cancer (LD-SCLC) patients. Frail conditions are: Eastern Cooperative Oncology Group performance status (ECOG PS) 2 or ECOG PS 0-1 and older than 70 or ECOG PS 0-1 and did not receive a concomitant thoracic chemo-radiotherapy (CRT) because of comorbidities. During the screening phase, patients complete either the standard concomitant thoracic CRT and cisplatin-etoposide regimen or a sequential CRT and carboplatin. Patients showing a disease control (defined as stable disease <math display="block">SD</math>, partial response <math display="block">PR</math>, or complete response <math display="block">CR</math> according to RECIST v1.1) at the radiological evaluation performed after the end of thoracic CRT can receive prophylactic cranial irradiation (PCI) as per local practice. They will then be randomized to receive durvalumab every 4 weeks (experimental arm A) or surveillance (control arm B) as per standard of care. Thus, DURVALUNG study aims to evaluate the efficacy of durvalumab maintenance treatment in frail LD-SCLC patients who have not progressed following platinum-based concomitant or sequential CRT.
  '''Sponsor''': UNICANCER
  '''Sponsor''': UNICANCER
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  '''Condition''': Small Cell Lung Carcinoma
  '''Condition''': Small Cell Lung Carcinoma
'''NCTID''': NCT01976182
'''NCTID''': NCT01976182
  '''Title''': Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia
  '''Title''': [[hasTrialTitle::Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia]]
  '''Study Summary''': LGL leukemia represents a rare subtype of chronic T or NK lymphoproliferative disorders. It is an indolent disease, the main hematological or autoimmune complications lead to a treatment in more than 60% of patients. Investigators set up at the University Hospital of Rennes, a database of more than 300 patients with LGL leukemia from major French services that support this disease, and published in 2010 the largest series of patients in the world (n = 229). However, the limited heterogeneity and retrospective data collected, as all previously released, makes it difficult the proposal of consensual treatment options. If first and second line treatments are based on the use of immunosuppression with methotrexate, cyclophosphamide, or cyclosporin A, no molecule has proven superiority over others. Methotrexate and cyclophosphamide are mainly used in the first line. Invetigators just have in the literature data on about 100 patients treated with either of these drugs. Combining the results of our series with those in the literature, invetigators estimate the respective overall response rate (RG) and complete response rate (CR) in 55% and 30% for methotrexate, and 60% and 50% for cyclophosphamide. Thus, there are four objective in this study : 1. to compare the respective efficacies of methotrexate and cyclophosphamide when administered as first-line therapies in patients suffering from TK LGL leukemia with severe neutropenia or neutropenia associated with infections, and/or anemia requiring transfusions, and/or auto-immune associated disease 2. to evaluate the percentage of patients refractory to methotrexate or cyclophosphamide for which a second line treatment is efficacious 3. to explore, in case of non-response to the first-line therapy, the efficacy of ciclosporine A, the comparison being performed with the treatment which was not administered in the first-line therapy 4. to evaluate the response rate according to the phenotypic subtype of LGL leukemia.
  '''Study Summary''': LGL leukemia represents a rare subtype of chronic T or NK lymphoproliferative disorders. It is an indolent disease, the main hematological or autoimmune complications lead to a treatment in more than 60% of patients. Investigators set up at the University Hospital of Rennes, a database of more than 300 patients with LGL leukemia from major French services that support this disease, and published in 2010 the largest series of patients in the world (n = 229). However, the limited heterogeneity and retrospective data collected, as all previously released, makes it difficult the proposal of consensual treatment options. If first and second line treatments are based on the use of immunosuppression with methotrexate, cyclophosphamide, or cyclosporin A, no molecule has proven superiority over others. Methotrexate and cyclophosphamide are mainly used in the first line. Invetigators just have in the literature data on about 100 patients treated with either of these drugs. Combining the results of our series with those in the literature, invetigators estimate the respective overall response rate (RG) and complete response rate (CR) in 55% and 30% for methotrexate, and 60% and 50% for cyclophosphamide. Thus, there are four objective in this study : 1. to compare the respective efficacies of methotrexate and cyclophosphamide when administered as first-line therapies in patients suffering from TK LGL leukemia with severe neutropenia or neutropenia associated with infections, and/or anemia requiring transfusions, and/or auto-immune associated disease 2. to evaluate the percentage of patients refractory to methotrexate or cyclophosphamide for which a second line treatment is efficacious 3. to explore, in case of non-response to the first-line therapy, the efficacy of ciclosporine A, the comparison being performed with the treatment which was not administered in the first-line therapy 4. to evaluate the response rate according to the phenotypic subtype of LGL leukemia.
  '''Sponsor''': Rennes University Hospital
  '''Sponsor''': Rennes University Hospital
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  '''Condition''': Large Granular Lymphocytes Leukemia
  '''Condition''': Large Granular Lymphocytes Leukemia
'''NCTID''': NCT02323516
'''NCTID''': NCT02323516
  '''Title''': Evaluation of the Efficacy of Low-dose Acetylsalicylic Acid on Diarrhea Induced by Anti-cancer Targeted Therapies.
  '''Title''': [[hasTrialTitle::Evaluation of the Efficacy of Low-dose Acetylsalicylic Acid on Diarrhea Induced by Anti-cancer Targeted Therapies]].
  '''Study Summary''': The mechanisms of action of the side effects associated with targeted therapies are still poorly understood. He was found in patients treated with gefitinib, increased levels of thromboxane B2 and P-selectin Thromboxane B2 is the result of the hydrolysis of thromboxane A2, which is itself obtained from Prostaglandin H2 under the action of the thromboxane synthetase. The thromboxane A2 is produced by platelets and the active pro-thrombotic properties as follows: stimulation of platelets and activation of other increased platelet aggregation. The selectins are cell adhesion proteins with a role in the adhesion phenomena. P-selectin is expressed by platelets and endothelial cells. The demonstration of increased plasma levels of thromboxane B2 and P-selectin leaves suggest a role of platelet activation in the occurrence of side effects associated with targeted therapies. Kanazawa’s study was conducted in 39 Japanese patients, trying to assess the value of low-dose acetylsalicylic acid or 100mg per day, that is to say, anti-aggrégantes doses, the occurrence rash and diarrhea induced by gefitinib. In this study, the group of patients treated with acetylsalicylic acid presented a lower rate of side effects significantly, 58.3% versus 77.8%. The frequency of diarrhea was 18.5% (or 5 patients) in the standard group versus 0% in the group with acetylsalicylic acid. Similarly, it was found a reduction in the occurrence of skin rash, 33.3% or 4 patients in the acetylsalicylic acid group versus 74.1% s, 20 patients in the standard group. Finally, in this study, it was not revealed significant differences in terms of response to treatment with gefitinib (37% in the standard group versus 33% in the group treated with aspirin patient) It does not exist in our knowledge of prospective data evaluating the effect of acetylsalicylic acid on the reduction of side effects associated with targeted in a population of patients of Caucasian-type treatment.
  '''Study Summary''': The mechanisms of action of the side effects associated with targeted therapies are still poorly understood. He was found in patients treated with gefitinib, increased levels of thromboxane B2 and P-selectin Thromboxane B2 is the result of the hydrolysis of thromboxane A2, which is itself obtained from Prostaglandin H2 under the action of the thromboxane synthetase. The thromboxane A2 is produced by platelets and the active pro-thrombotic properties as follows: stimulation of platelets and activation of other increased platelet aggregation. The selectins are cell adhesion proteins with a role in the adhesion phenomena. P-selectin is expressed by platelets and endothelial cells. The demonstration of increased plasma levels of thromboxane B2 and P-selectin leaves suggest a role of platelet activation in the occurrence of side effects associated with targeted therapies. Kanazawa’s study was conducted in 39 Japanese patients, trying to assess the value of low-dose acetylsalicylic acid or 100mg per day, that is to say, anti-aggrégantes doses, the occurrence rash and diarrhea induced by gefitinib. In this study, the group of patients treated with acetylsalicylic acid presented a lower rate of side effects significantly, 58.3% versus 77.8%. The frequency of diarrhea was 18.5% (or 5 patients) in the standard group versus 0% in the group with acetylsalicylic acid. Similarly, it was found a reduction in the occurrence of skin rash, 33.3% or 4 patients in the acetylsalicylic acid group versus 74.1% s, 20 patients in the standard group. Finally, in this study, it was not revealed significant differences in terms of response to treatment with gefitinib (37% in the standard group versus 33% in the group treated with aspirin patient) It does not exist in our knowledge of prospective data evaluating the effect of acetylsalicylic acid on the reduction of side effects associated with targeted in a population of patients of Caucasian-type treatment.
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Cancer
  '''Condition''': Cancer
'''NCTID''': NCT05132582
'''NCTID''': NCT05132582
  '''Title''': A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
  '''Title''': [[hasTrialTitle::A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer]]
  '''Study Summary''': This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.
  '''Study Summary''': This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.
  '''Sponsor''': Seagen Inc.
  '''Sponsor''': Seagen Inc.
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  '''Condition''': HER2 Positive Breast Cancer
  '''Condition''': HER2 Positive Breast Cancer
'''NCTID''': NCT03420105
'''NCTID''': NCT03420105
  '''Title''': Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep
  '''Title''': [[hasTrialTitle::Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep]]
  '''Study Summary''': The results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. In the long term, a better understanding will make it possible to envisage appropriate treatments to compensate for these memory difficulties and to improve the autonomy of the patients.
  '''Study Summary''': The results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. In the long term, a better understanding will make it possible to envisage appropriate treatments to compensate for these memory difficulties and to improve the autonomy of the patients.
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Breast Cancer
  '''Condition''': Breast Cancer
'''NCTID''': NCT03197805
'''NCTID''': NCT03197805
  '''Title''': Assessment of the Impact of RNA Genomic Profile on Treatment Decision-making in HER2 Equivocal Breast Cancer Patients
  '''Title''': [[hasTrialTitle::Assessment of the Impact of RNA Genomic Profile on Treatment Decision-making in HER2 Equivocal Breast Cancer Patients]]
  '''Study Summary''': The American Society of Clinical Oncology (ASCO) and the /College of American Pathologists (CAP) recommend that HER2 status (negative or positive) must be determined in all patients with invasive breast cancer. The knowledge of HER2 status will help the oncologist in prescribing or not a HER2-targeted therapy to patients. Presently, two main methods are used to assess HER2 status: immunohistochemistry (IHC, protein expression) and in situ hybridization (ISH, gene expression) in order to classify tumor sample as positive, negative or equivocal. When a tumor is classified HER 2+ by IHC method, a second test is performed using ISH methods (FISH, SISH, CISH). In case of HER2 equivocal result with ISH method (4 ≤HER2 gene number copy &lt;6), the patient is eligible to an anti-HER2 therapy after discussed during MD-MM. This decision should be individualized on the basis of patient status (comorbidities and prognosis) and patient preferences after discussing available clinical evidence. Based on molecular classification, RNA expression could help to discriminate breast cancer subtypes (luminal A, luminal B, HER2-overexpressed and triple negative). Prosigna is a genomic test, developed by NanoString® based on the PAM50 gene signature, which measures the expression of 50 genes to classify tumors into 1 of 4 intrinsic subtypes and could allow determining the HER2 status. This study was designed in order to define if such a test could help the oncologist to define the better therapeutic decision in a HER2 equivocal population. In addition, concordance tests will be performed. The aim of this study is to assess the modification decision rate between the first and the second multidisciplinary decision-making meeting in HER2 equivocal patients using genomic testing.
  '''Study Summary''': The American Society of Clinical Oncology (ASCO) and the /College of American Pathologists (CAP) recommend that HER2 status (negative or positive) must be determined in all patients with invasive breast cancer. The knowledge of HER2 status will help the oncologist in prescribing or not a HER2-targeted therapy to patients. Presently, two main methods are used to assess HER2 status: immunohistochemistry (IHC, protein expression) and in situ hybridization (ISH, gene expression) in order to classify tumor sample as positive, negative or equivocal. When a tumor is classified HER 2+ by IHC method, a second test is performed using ISH methods (FISH, SISH, CISH). In case of HER2 equivocal result with ISH method (4 ≤HER2 gene number copy &lt;6), the patient is eligible to an anti-HER2 therapy after discussed during MD-MM. This decision should be individualized on the basis of patient status (comorbidities and prognosis) and patient preferences after discussing available clinical evidence. Based on molecular classification, RNA expression could help to discriminate breast cancer subtypes (luminal A, luminal B, HER2-overexpressed and triple negative). Prosigna is a genomic test, developed by NanoString® based on the PAM50 gene signature, which measures the expression of 50 genes to classify tumors into 1 of 4 intrinsic subtypes and could allow determining the HER2 status. This study was designed in order to define if such a test could help the oncologist to define the better therapeutic decision in a HER2 equivocal population. In addition, concordance tests will be performed. The aim of this study is to assess the modification decision rate between the first and the second multidisciplinary decision-making meeting in HER2 equivocal patients using genomic testing.
  '''Sponsor''': Centre Jean Perrin
  '''Sponsor''': Centre Jean Perrin
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  '''Condition''': Breast Cancer
  '''Condition''': Breast Cancer
'''NCTID''': NCT04290663
'''NCTID''': NCT04290663
  '''Title''': Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up
  '''Title''': [[hasTrialTitle::Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up]]
  '''Study Summary''': This trial is comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy
  '''Study Summary''': This trial is comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Thyroid Cancer
  '''Condition''': Thyroid Cancer
'''NCTID''': NCT02317393
'''NCTID''': NCT02317393
  '''Title''': Contribution of the Imaging to the Expression of intégrines αvβ3 for the Characterization of Residual Masses of Non-seminoma Tumors at the End of Chemotherapy
  '''Title''': [[hasTrialTitle::Contribution of the Imaging to the Expression of intégrines αvβ3 for the Characterization of Residual Masses of Non-seminoma Tumors at the End of Chemotherapy]]
  '''Study Summary''': The purpose of this study is to evaluate the contribution of the imaging to the expression of intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the end of chemotherapy. The investigators hope that the results of this first stage of the clinical trial come to consolidate the preclinical results obtained by the investigators team to characterizing the interest and the strong contribution of the use of a tracer resting on the expression of αvβ3 integrine for the diagnosis of simple necrosed mass at the end of the treatment of a non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients.
  '''Study Summary''': The purpose of this study is to evaluate the contribution of the imaging to the expression of intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the end of chemotherapy. The investigators hope that the results of this first stage of the clinical trial come to consolidate the preclinical results obtained by the investigators team to characterizing the interest and the strong contribution of the use of a tracer resting on the expression of αvβ3 integrine for the diagnosis of simple necrosed mass at the end of the treatment of a non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients.
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Non-seminomatous Germ Cell Tumors
  '''Condition''': Non-seminomatous Germ Cell Tumors
'''NCTID''': NCT05122806
'''NCTID''': NCT05122806
  '''Title''': Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC
  '''Title''': [[hasTrialTitle::Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC]]
  '''Study Summary''': BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with next generation TKIs in first line, included in the national EXPLORE ALK cohort (GFPC 03-2019), a non-interventional, national, multi-center cohort of ALK-rearranged NSCLC patients. BioExALK study will be proposed to every patient included in the Explore ALK GFPC 03-2019 study. Biological analysis will be performed on tumor tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA (ctDNA). For plasma testing, after obtained patient consent, blood samples will be taken and analyzed at the Léon Bérard Center (Lyon). Biological analysis on tissue obtained at diagnosis and at disease progression will be collected and be sent for centralized analysis to the Rouen University Hospital.
  '''Study Summary''': BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with next generation TKIs in first line, included in the national EXPLORE ALK cohort (GFPC 03-2019), a non-interventional, national, multi-center cohort of ALK-rearranged NSCLC patients. BioExALK study will be proposed to every patient included in the Explore ALK GFPC 03-2019 study. Biological analysis will be performed on tumor tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA (ctDNA). For plasma testing, after obtained patient consent, blood samples will be taken and analyzed at the Léon Bérard Center (Lyon). Biological analysis on tissue obtained at diagnosis and at disease progression will be collected and be sent for centralized analysis to the Rouen University Hospital.
  '''Sponsor''': Groupe Francais De Pneumo-Cancerologie
  '''Sponsor''': Groupe Francais De Pneumo-Cancerologie
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  '''Condition''': Non-small Cell Lung Cancer
  '''Condition''': Non-small Cell Lung Cancer
'''NCTID''': NCT01740427
'''NCTID''': NCT01740427
  '''Title''': A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
  '''Title''': [[hasTrialTitle::A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)]]
  '''Study Summary''': The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.
  '''Study Summary''': The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.
  '''Sponsor''': Pfizer
  '''Sponsor''': Pfizer
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  '''Condition''': Breast Neoplasms
  '''Condition''': Breast Neoplasms
'''NCTID''': NCT03275506
'''NCTID''': NCT03275506
  '''Title''': PEMBRO With Chemo in Neo Adj Treatment of Ovarian Cancer .
  '''Title''': [[hasTrialTitle::PEMBRO With Chemo in Neo Adj Treatment of Ovarian Cancer]].
  '''Study Summary''': There are several data suggesting that pembrolizumab and bevacizumab may be synergistic. Enhanced tumor angiogenesis is commonly associated with absence of tumor-infiltrating T cells in patients. There is evidence in OC that tumor expression of VEGF is negatively correlated to the density of CD3+TILs and this phenotype is associated with early recurrence, consistent with prior studies showing a correlation of VEGF to early recurrence and short survival. Furthermore, in ascites, high levels of VEGF correlate to low numbers of NK T-like CD3+CD56+ cells This randomized phase II study aims to evaluate the efficacy of pembrolizumab in combina-tion with the standard neo adjuvant chemotherapy followed by IDS and the safety of this strategy in patients with advanced ovarian cancer. We assume that its administration in the neo adjuvant setting combination with standard of care (4 cycles of standard chemotherapy) would improve the response rate and consequently will help to achieve optimal debulking rate at IDS. After surgery, patients will continue to be treated with standard of care (chemotherapy for 2 to 5 cycles plus or less bevacizumab) or the same combination plus pembrolizumab (keytruda).
  '''Study Summary''': There are several data suggesting that pembrolizumab and bevacizumab may be synergistic. Enhanced tumor angiogenesis is commonly associated with absence of tumor-infiltrating T cells in patients. There is evidence in OC that tumor expression of VEGF is negatively correlated to the density of CD3+TILs and this phenotype is associated with early recurrence, consistent with prior studies showing a correlation of VEGF to early recurrence and short survival. Furthermore, in ascites, high levels of VEGF correlate to low numbers of NK T-like CD3+CD56+ cells This randomized phase II study aims to evaluate the efficacy of pembrolizumab in combina-tion with the standard neo adjuvant chemotherapy followed by IDS and the safety of this strategy in patients with advanced ovarian cancer. We assume that its administration in the neo adjuvant setting combination with standard of care (4 cycles of standard chemotherapy) would improve the response rate and consequently will help to achieve optimal debulking rate at IDS. After surgery, patients will continue to be treated with standard of care (chemotherapy for 2 to 5 cycles plus or less bevacizumab) or the same combination plus pembrolizumab (keytruda).
  '''Sponsor''': ARCAGY/ GINECO GROUP
  '''Sponsor''': ARCAGY/ GINECO GROUP
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  '''Condition''': Ovarian Cancer Stage IV
  '''Condition''': Ovarian Cancer Stage IV
'''NCTID''': NCT03518606
'''NCTID''': NCT03518606
  '''Title''': Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours
  '''Title''': [[hasTrialTitle::Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours]]
  '''Study Summary''': This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours.
  '''Study Summary''': This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours.
  '''Sponsor''': UNICANCER
  '''Sponsor''': UNICANCER
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  '''Condition''': Advanced Solid Tumours
  '''Condition''': Advanced Solid Tumours
'''NCTID''': NCT00467506
'''NCTID''': NCT00467506
  '''Title''': Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma
  '''Title''': [[hasTrialTitle::Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma]]
  '''Study Summary''': Phase II clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy using anti-CEAxanti-DTPA bispecific antibody and di-DTPA-131I peptide in patients with reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling time lower than 5 years)
  '''Study Summary''': Phase II clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy using anti-CEAxanti-DTPA bispecific antibody and di-DTPA-131I peptide in patients with reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling time lower than 5 years)
  '''Sponsor''': Nantes University Hospital
  '''Sponsor''': Nantes University Hospital
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  '''Condition''': Thyroid Neoplasms
  '''Condition''': Thyroid Neoplasms
'''NCTID''': NCT03651206
'''NCTID''': NCT03651206
  '''Title''': Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib
  '''Title''': [[hasTrialTitle::Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib]]
  '''Study Summary''': Carcinosarcomas (CS) (malignant mixed Müllerian tumors) are highly aggressive and rare tumors with a worldwide annual incidence between 0.5-3.3 cases/100.000 women. Gynecological CS, i.e. ovarian CS (OCS) and uterine CS (UCS), have a 5-year overall survival (OS) &lt; 10% and a poor prognosis. After initial treatment (surgery +/- adjuvant radiotherapies +/- chemotherapies (CT)), vast majority of patients relapsed and received diverse CT producing modest benefits, and nearly all patients will die. After first line CT including platinum salt, monotherapy (doxorubicin or paclitaxel) is frequently used for relapsed patients, but the response rate (RR) is &lt;20%, progression-free survival (PFS) &lt;4 months, and OS &lt;1 year. In this unmet need situation, a better knowledge of these aggressive neoplasms is essential to propose new therapeutic options.
  '''Study Summary''': Carcinosarcomas (CS) (malignant mixed Müllerian tumors) are highly aggressive and rare tumors with a worldwide annual incidence between 0.5-3.3 cases/100.000 women. Gynecological CS, i.e. ovarian CS (OCS) and uterine CS (UCS), have a 5-year overall survival (OS) &lt; 10% and a poor prognosis. After initial treatment (surgery +/- adjuvant radiotherapies +/- chemotherapies (CT)), vast majority of patients relapsed and received diverse CT producing modest benefits, and nearly all patients will die. After first line CT including platinum salt, monotherapy (doxorubicin or paclitaxel) is frequently used for relapsed patients, but the response rate (RR) is &lt;20%, progression-free survival (PFS) &lt;4 months, and OS &lt;1 year. In this unmet need situation, a better knowledge of these aggressive neoplasms is essential to propose new therapeutic options.
  '''Sponsor''': ARCAGY/ GINECO GROUP
  '''Sponsor''': ARCAGY/ GINECO GROUP
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  '''Condition''': Ovarian Carcinosarcoma
  '''Condition''': Ovarian Carcinosarcoma
'''NCTID''': NCT03438552
'''NCTID''': NCT03438552
  '''Title''': Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence
  '''Title''': [[hasTrialTitle::Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence]]
  '''Study Summary''': Stereo-Re-Pro aims to provide further evidence of Stereotactic Body Radiotherapy (SBRT) as a supplementary non-invasive curative treatment for local recurrence following radiotherapy. The objective of the first part of the trial (Phase I) is to select the recommended dose for salvage SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy) based on dose-limiting toxicity observed during the 18 weeks following the initiation of salvage-SBRT. Particular attention will be paid to the quality of life and tolerance of the treatment. The objective of the second part of the trial (phase II) is to estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate.
  '''Study Summary''': Stereo-Re-Pro aims to provide further evidence of Stereotactic Body Radiotherapy (SBRT) as a supplementary non-invasive curative treatment for local recurrence following radiotherapy. The objective of the first part of the trial (Phase I) is to select the recommended dose for salvage SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy) based on dose-limiting toxicity observed during the 18 weeks following the initiation of salvage-SBRT. Particular attention will be paid to the quality of life and tolerance of the treatment. The objective of the second part of the trial (phase II) is to estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate.
  '''Sponsor''': UNICANCER
  '''Sponsor''': UNICANCER
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  '''Condition''': Local Recurrence of Malignant Tumor of Prostate
  '''Condition''': Local Recurrence of Malignant Tumor of Prostate
'''NCTID''': NCT01792726
'''NCTID''': NCT01792726
  '''Title''': A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer.
  '''Title''': [[hasTrialTitle::A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer]].
  '''Study Summary''': TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial in which each participating centre can use the local predefined inclusion/exclusion criteria for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are eligible to enter patients into the trial. Eligible patients are those with a higher risk of local recurrence after breast conserving surgery. After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All patients will receive whole breast EBRT. They may receive any other adjuvant treatments as deemed necessary. The protocol recommends that patients be followed at six monthly intervals for three years and then annually. The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are relapse-free survival, site of recurrence, overall survival (breast-cancer specific and non-breast cancer deaths) patient satisfaction and quality of life.
  '''Study Summary''': TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial in which each participating centre can use the local predefined inclusion/exclusion criteria for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are eligible to enter patients into the trial. Eligible patients are those with a higher risk of local recurrence after breast conserving surgery. After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All patients will receive whole breast EBRT. They may receive any other adjuvant treatments as deemed necessary. The protocol recommends that patients be followed at six monthly intervals for three years and then annually. The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are relapse-free survival, site of recurrence, overall survival (breast-cancer specific and non-breast cancer deaths) patient satisfaction and quality of life.
  '''Sponsor''': University College, London
  '''Sponsor''': University College, London
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  '''Condition''': Early Breast Cancer
  '''Condition''': Early Breast Cancer
'''NCTID''': NCT04015804
'''NCTID''': NCT04015804
  '''Title''': Robotic Low Rectum Anterior Resection
  '''Title''': [[hasTrialTitle::Robotic Low Rectum Anterior Resection]]
  '''Study Summary''': The laparoscopic approach for total mesorectal excision (L-TME) results improved short-term outcomes. However this approach has technical limitations when the pelvis is narrow and deep. Indeed there is a limited mobility of straight laparoscopic instruments and associated loss of dexterity, unstable camera view and compromised ergonomics for the surgeon. Robotic technology was developed to reduce these limitations and offers the advantages of intuitive manipulation of laparoscopic instruments with wrist articulation, a 3-dimensional field of view, a stable camera platform with zoom magnification, dexterity enhancement and an ergonomic operating environment. A major advantage of the robotic approach is the surgeon’s simultaneous control of the camera and of the two or three additional instruments. This advantage facilitates traction and counter-traction. The technological advantages of robotic surgery should also allow a finer dissection in a narrow pelvic cavity.
  '''Study Summary''': The laparoscopic approach for total mesorectal excision (L-TME) results improved short-term outcomes. However this approach has technical limitations when the pelvis is narrow and deep. Indeed there is a limited mobility of straight laparoscopic instruments and associated loss of dexterity, unstable camera view and compromised ergonomics for the surgeon. Robotic technology was developed to reduce these limitations and offers the advantages of intuitive manipulation of laparoscopic instruments with wrist articulation, a 3-dimensional field of view, a stable camera platform with zoom magnification, dexterity enhancement and an ergonomic operating environment. A major advantage of the robotic approach is the surgeon’s simultaneous control of the camera and of the two or three additional instruments. This advantage facilitates traction and counter-traction. The technological advantages of robotic surgery should also allow a finer dissection in a narrow pelvic cavity.
  '''Sponsor''': Institut du Cancer de Montpellier - Val d’Aurelle
  '''Sponsor''': Institut du Cancer de Montpellier - Val d’Aurelle
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  '''Condition''': Rectum Cancer
  '''Condition''': Rectum Cancer
'''NCTID''': NCT04675827
'''NCTID''': NCT04675827
  '''Title''': De-escalation Adjuvant Chemo in HER2+/ER-ode-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo &amp; Dual HER2 Blockade
  '''Title''': [[hasTrialTitle::De-escalation Adjuvant Chemo in HER2+/ER-ode-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo; Dual HER2 Blockade]]
  '''Study Summary''': DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4 cycles) combined with subcutaneous (SC) fixed dose combination (FDC) of pertuzumab and trastuzumab (loading dose of 1200 mg pertuzumab and 600 mg trastuzumab, followed by 600 mg pertuzumab and 600 mg trastuzumab) every 3 weeks for 4 cycles. Surgery will be performed according to local guidelines in all subjects after neoadjuvant treatment. After surgery, subjects who achieve a pCR (defined as pT0/Tis pN0) will receive adjuvant pertuzumab and trastuzumab FDC SC for additional 14 cycles. Subjects with residual invasive disease will receive salvage adjuvant trastuzumab emtansine (T-DM1, 3.6 mg/kg, IV every 3 weeks) for 14 cycles. In subjects whose residual invasive disease is classified per RCB score as ≥2, 3 to 4 cycles of anthracycline-based chemotherapy may be administered, at the investigator’s discretion, before the 14 cycles of T-DM1. If histopathological analysis finds that the surgical specimen from a subject with residual disease is ER-positive and/or PR-positive, adjuvant endocrine therapy may be administered concomitantly with study treatment, at the investigator’s discretion and according to local guidelines. Adjuvant radiotherapy will be mandatory after breast-conserving surgery, whereas it will be performed according to local guidelines after mastectomy, and it will be administered concomitantly with pertuzumab and trastuzumab FDC SC in subjects who achieve a pCR, and concomitantly with T-DM1 in subjects with residual invasive disease (after anthracycline-based chemotherapy in subjects assigned to receive this treatment).
  '''Study Summary''': DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4 cycles) combined with subcutaneous (SC) fixed dose combination (FDC) of pertuzumab and trastuzumab (loading dose of 1200 mg pertuzumab and 600 mg trastuzumab, followed by 600 mg pertuzumab and 600 mg trastuzumab) every 3 weeks for 4 cycles. Surgery will be performed according to local guidelines in all subjects after neoadjuvant treatment. After surgery, subjects who achieve a pCR (defined as pT0/Tis pN0) will receive adjuvant pertuzumab and trastuzumab FDC SC for additional 14 cycles. Subjects with residual invasive disease will receive salvage adjuvant trastuzumab emtansine (T-DM1, 3.6 mg/kg, IV every 3 weeks) for 14 cycles. In subjects whose residual invasive disease is classified per RCB score as ≥2, 3 to 4 cycles of anthracycline-based chemotherapy may be administered, at the investigator’s discretion, before the 14 cycles of T-DM1. If histopathological analysis finds that the surgical specimen from a subject with residual disease is ER-positive and/or PR-positive, adjuvant endocrine therapy may be administered concomitantly with study treatment, at the investigator’s discretion and according to local guidelines. Adjuvant radiotherapy will be mandatory after breast-conserving surgery, whereas it will be performed according to local guidelines after mastectomy, and it will be administered concomitantly with pertuzumab and trastuzumab FDC SC in subjects who achieve a pCR, and concomitantly with T-DM1 in subjects with residual invasive disease (after anthracycline-based chemotherapy in subjects assigned to receive this treatment).
  '''Sponsor''': Jules Bordet Institute
  '''Sponsor''': Jules Bordet Institute
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  '''Condition''': HER2-positive Breast Cancer
  '''Condition''': HER2-positive Breast Cancer
'''NCTID''': NCT01436617
'''NCTID''': NCT01436617
  '''Title''': Assessing the Value of a Dosage of Anti-cetuximab in the Therapeutic Management of Patients With Colon Cancer or Upper Aero-digestive Tract and Candidates for Treatment With Cetuximab
  '''Title''': [[hasTrialTitle::Assessing the Value of a Dosage of Anti-cetuximab in the Therapeutic Management of Patients With Colon Cancer or Upper Aero-digestive Tract and Candidates for Treatment With Cetuximab]]
  '''Study Summary''': The main objective of this study is to validate the utility of IgE anti-cetuximab in the treatment strategy to identify patients at risk for a severe allergic reaction to cetuximab (grade 3 or 4 of the classification of NCI) and thus reduce the incidence of severe reactions.
  '''Study Summary''': The main objective of this study is to validate the utility of IgE anti-cetuximab in the treatment strategy to identify patients at risk for a severe allergic reaction to cetuximab (grade 3 or 4 of the classification of NCI) and thus reduce the incidence of severe reactions.
  '''Sponsor''': Centre Francois Baclesse
  '''Sponsor''': Centre Francois Baclesse
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  '''Condition''': Colon Cancer
  '''Condition''': Colon Cancer
'''NCTID''': NCT03428217
'''NCTID''': NCT03428217
  '''Title''': CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma
  '''Title''': [[hasTrialTitle::CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma]]
  '''Study Summary''': Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC).
  '''Study Summary''': Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC).
  '''Sponsor''': Calithera Biosciences, Inc
  '''Sponsor''': Calithera Biosciences, Inc
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  '''Recruitment Status''': COMPLETED
  '''Recruitment Status''': COMPLETED
  '''Condition''': Advanced Renal Cell Carcinoma
  '''Condition''': Advanced Renal Cell Carcinoma
<span style="display:none">hasTrialTitle::Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer</span>
<span style="display:none">hasTrialTitle::Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas</span>
<span style="display:none">hasTrialTitle::SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients</span>
<span style="display:none">hasTrialTitle::Pemetrexed Plus Cisplatin for Brain Metastasis of Advanced Non - Small Cell Lung Cancer (NSCLC)</span>
<span style="display:none">hasTrialTitle::Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract</span>
<span style="display:none">hasTrialTitle::Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer</span>
<span style="display:none">hasTrialTitle::OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC</span>
<span style="display:none">hasTrialTitle::Impact of a Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients</span>
<span style="display:none">hasTrialTitle::Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology</span>
<span style="display:none">hasTrialTitle::Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients</span>
<span style="display:none">hasTrialTitle::Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD</span>
<span style="display:none">hasTrialTitle::Adjuvant Pazopanib in Stage I NSCLC</span>
<span style="display:none">hasTrialTitle::Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma</span>
<span style="display:none">hasTrialTitle::Shared Meditation Involving People With Cancer, Carers and Third Parties</span>
<span style="display:none">hasTrialTitle::National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis (ALTITUDES)</span>
<span style="display:none">hasTrialTitle::D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma</span>
<span style="display:none">hasTrialTitle::National Evaluation of the Adherence to Recommendations of Venous Thrombo Embolism Treatment in Cancer Patients</span>
<span style="display:none">hasTrialTitle::Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease</span>
<span style="display:none">hasTrialTitle::Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT)</span>
<span style="display:none">hasTrialTitle::Changes in the MRI Signal in Patients With Benign Tumors of the Brain and Meninges Treated With Proton Therapy: Impact of TEL and the Biological Dose Received</span>
<span style="display:none">hasTrialTitle::Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib</span>
<span style="display:none">hasTrialTitle::Efficacy of Parenteral Nutrition in Patients at the Palliative Phase of Cancer</span>
<span style="display:none">hasTrialTitle::Comparison of MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) in Cognitive Assessment in Geriatric Oncology</span>
<span style="display:none">hasTrialTitle::Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer</span>
<span style="display:none">hasTrialTitle::A Web-mediated Follow-up With the Web-application KidneyPRO Versus Standard Follow-up for Patients With Advanced Renal Cell Carcinoma Treated With Axitinib/Pembrolizumab in First Line</span>
<span style="display:none">hasTrialTitle::Chemotherapy and Immunotherapy as Treatment for MSS Metastatic Colorectal Cancer With High Immune Infiltrate</span>
<span style="display:none">hasTrialTitle::Study of a Treatment Driven by Early PET Response to a Treatment Not Monitored by Early PET in Patients With AA Stage 3-4 or 2B HL</span>
<span style="display:none">hasTrialTitle::Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3''10 Gy) to the Historical Single-dose Radiosurgery (1''20 to 25 Gy) With Medico-economic Evaluation</span>
<span style="display:none">hasTrialTitle::UTOLA: UTerin OLAparib</span>
<span style="display:none">hasTrialTitle::Impact of the COVID-19 Infectious Epidemic on the Management of Oncology and Onco-hematology Patients and on the Psychological Consequences for Patients and Caregivers</span>
<span style="display:none">hasTrialTitle::Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer</span>
<span style="display:none">hasTrialTitle::Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer</span>
<span style="display:none">hasTrialTitle::Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer</span>
<span style="display:none">hasTrialTitle::Medical and Economic Evaluation for Intermediate-risk Prostate Cancer</span>
<span style="display:none">hasTrialTitle::Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head &amp; Neck Cancers</span>
<span style="display:none">hasTrialTitle::QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program</span>
<span style="display:none">hasTrialTitle::NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy</span>
<span style="display:none">hasTrialTitle::Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation</span>
<span style="display:none">hasTrialTitle::Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment</span>
<span style="display:none">hasTrialTitle::Mesothelioma Avastin Plus Pemetrexed-cisplatin Study</span>
<span style="display:none">hasTrialTitle::Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy</span>
<span style="display:none">hasTrialTitle::Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)</span>
<span style="display:none">hasTrialTitle::Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)</span>
<span style="display:none">hasTrialTitle::Paclitaxel/Pazopanib for Platinum Resistant/Refractory Ovarian Cancer</span>
<span style="display:none">hasTrialTitle::AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy</span>
<span style="display:none">hasTrialTitle::An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene</span>
<span style="display:none">hasTrialTitle::A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types</span>
<span style="display:none">hasTrialTitle::Endometrial Cancer Patientes MMR Deficient Comparing Chimiotherapy vs Dostarlimab in First Line</span>
<span style="display:none">hasTrialTitle::Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer</span>
<span style="display:none">hasTrialTitle::Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL)</span>
<span style="display:none">hasTrialTitle::Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR</span>
<span style="display:none">hasTrialTitle::Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Postoperative Radiotherapy for Breast Cancer</span>
<span style="display:none">hasTrialTitle::Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH</span>
<span style="display:none">hasTrialTitle::Radiotherapy of Multiple Brain Metastases Using AGuIX®</span>
<span style="display:none">hasTrialTitle::Prevention of Alopecia in Patients With Localised Breast Cancer</span>
<span style="display:none">hasTrialTitle::Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer</span>
<span style="display:none">hasTrialTitle::Treatment Intensification With Temozolomide in Adults With a Glioblastoma</span>
<span style="display:none">hasTrialTitle::A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC</span>
<span style="display:none">hasTrialTitle::Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay</span>
<span style="display:none">hasTrialTitle::Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer</span>
<span style="display:none">hasTrialTitle::Frontline Therapy in de Novo Multiple Myeloma Patients Under 65</span>
<span style="display:none">hasTrialTitle::Feasibility of Adapted Physical Activity Based on a Walking Platform in Hospitalized Old Patients for Cancer</span>
<span style="display:none">hasTrialTitle::Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs</span>
<span style="display:none">hasTrialTitle::First-line Gemcitabine/Cisplatin +/- Avelumab in Locally Advanced or Metastatic Bladder Carcinoma</span>
<span style="display:none">hasTrialTitle::TroVax Renal Immunotherapy Survival Trial</span>
<span style="display:none">hasTrialTitle::NIraparib and Quality Of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib</span>
<span style="display:none">hasTrialTitle::Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma</span>
<span style="display:none">hasTrialTitle::Phase II Study to Evaluate MAintenance Therapy With Olaparib or Selumetinib Plus Durvalumab According to BRCAness and KRAS Somatic Status Personalized in Metastatic Pancreatic Adenocarcinoma Patients</span>
<span style="display:none">hasTrialTitle::Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer</span>
<span style="display:none">hasTrialTitle::TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention</span>
<span style="display:none">hasTrialTitle::PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 %</span>
<span style="display:none">hasTrialTitle::Study of LY2228820 With Radiotherapy Plus Concomitant TMZ in the Treatment of Newly Diagnosed Glioblastoma</span>
<span style="display:none">hasTrialTitle::Etiosarc: Environmental Aetiology of Sarcomas From a Multicenter French Population-based Case-control Study Among Adults</span>
<span style="display:none">hasTrialTitle::Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers</span>
<span style="display:none">hasTrialTitle::Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway</span>
<span style="display:none">hasTrialTitle::Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma</span>
<span style="display:none">hasTrialTitle::An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene</span>
<span style="display:none">hasTrialTitle::Durvalumab Maintenance After Thoracic Chemoradiotherapy in Frail Small Cell Lung Cancer Patients Whose Disease is Limited to the Thorax</span>
<span style="display:none">hasTrialTitle::Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia</span>
<span style="display:none">hasTrialTitle::Evaluation of the Efficacy of Low-dose Acetylsalicylic Acid on Diarrhea Induced by Anti-cancer Targeted Therapies</span>
<span style="display:none">hasTrialTitle::A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer</span>
<span style="display:none">hasTrialTitle::Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep</span>
<span style="display:none">hasTrialTitle::Assessment of the Impact of RNA Genomic Profile on Treatment Decision-making in HER2 Equivocal Breast Cancer Patients</span>
<span style="display:none">hasTrialTitle::Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up</span>
<span style="display:none">hasTrialTitle::Contribution of the Imaging to the Expression of intégrines αvβ3 for the Characterization of Residual Masses of Non-seminoma Tumors at the End of Chemotherapy</span>
<span style="display:none">hasTrialTitle::Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC</span>
<span style="display:none">hasTrialTitle::A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)</span>
<span style="display:none">hasTrialTitle::PEMBRO With Chemo in Neo Adj Treatment of Ovarian Cancer</span>
<span style="display:none">hasTrialTitle::Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours</span>
<span style="display:none">hasTrialTitle::Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma</span>
<span style="display:none">hasTrialTitle::Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib</span>
<span style="display:none">hasTrialTitle::Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence</span>
<span style="display:none">hasTrialTitle::A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer</span>
<span style="display:none">hasTrialTitle::Robotic Low Rectum Anterior Resection</span>
<span style="display:none">hasTrialTitle::De-escalation Adjuvant Chemo in HER2+/ER-ode-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo; Dual HER2 Blockade</span>
<span style="display:none">hasTrialTitle::Assessing the Value of a Dosage of Anti-cetuximab in the Therapeutic Management of Patients With Colon Cancer or Upper Aero-digestive Tract and Candidates for Treatment With Cetuximab</span>
<span style="display:none">hasTrialTitle::CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma</span>
<span style="display:none">hasCancerType::C00-D48: All neoplasms</span>
<span style="display:none">hasCancerType::C00-C97: All cancer types</span>
<span style="display:none">hasCancerType::C00-C14: Mouth/throat cancers</span>
<span style="display:none">hasCancerType::C15-C26: Digestive system cancers</span>
<span style="display:none">hasCancerType::C30-C39: Lung/chest cancers</span>
<span style="display:none">hasCancerType::C40-C41: Bone cancers</span>
<span style="display:none">hasCancerType::C43-C44: Skin cancers/melanoma</span>
<span style="display:none">hasCancerType::C45-C49: Soft tissue cancer</span>
<span style="display:none">hasCancerType::C50: Breast cancer</span>
<span style="display:none">hasCancerType::C51-C58: Female genitalia cancers</span>
<span style="display:none">hasCancerType::C60-C63: Male genitalia cancer</span>
<span style="display:none">hasCancerType::C64-C68: Urinary system cancers</span>
<span style="display:none">hasCancerType::C69-C72: Eye and brain cancer</span>
<span style="display:none">hasCancerType::C73-C75: Thyroid and other gland cancers</span>
<span style="display:none">hasCancerType::C76-C80: Cancers of unknown or unspecified areas</span>
<span style="display:none">hasCancerType::C81-C96: Cancers of the blood and immune system</span>
<span style="display:none">hasCancerType::C97-C97: Cancers in multiple locations from the start</span>
<span style="display:none">hasCancerType::D00-D09: Early-stage cancers not yet spread</span>
<span style="display:none">hasCancerType::D10-D36: Benign tumour</span>
<span style="display:none">hasCancerType::D37-D48: Growths of uncertain nature</span>
<span style="display:none">hasCancerType::unknown</span>
<span style="display:none">isTrial</span>

Latest revision as of 18:44, 14 December 2025

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NCTID: NCT01827943 

Title: Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer
Study Summary: In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival.
Sponsor: Institut Bergonié
Intervention: Temsirolimus
Start Date: 2009-06
Last Updated: 2021-05-06
Number of Patients: 54
Recruitment Status: COMPLETED
Condition: Relapsed Bladder Cancer

NCTID: NCT01303497 

Title: Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas
Study Summary: Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma
Sponsor: Centre Oscar Lambret
Intervention: Paclitaxel
Start Date: 2010-09-10
Last Updated: 2019-05-30
Number of Patients: 70
Recruitment Status: COMPLETED
Condition: Angiosarcoma

NCTID: NCT02117167 

Title: SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients
Study Summary: Open label multicentric randomized phase II trial, using high throughput genome analysis as a therapeutic decision tool, aimed at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with a standard treatment (pemetrexed in Non-squamous patients and erlotinib in squamous cells, targeted substudy 1) as well as immunotherapy with maintenance therapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).
Sponsor: UNICANCER
Intervention: AZD2014
Start Date: 2014-04-23
Last Updated: 2022-08-02
Number of Patients: 999
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: Non-small Cell Lung Cancer Metastatic

NCTID: NCT00744900 

Title: Pemetrexed Plus Cisplatin for Brain Metastasis of Advanced Non - Small Cell Lung Cancer (NSCLC)
Study Summary: NSCLC patients often have cerebral metastasis : 10% at diagnosis and 40% during disease management. Neurosurgery is not indicated in the majority of cases because of presence of several lesions in the brain, failure of primary tumor control or presence of extra-cerebral metastasis. Cerebral metastasis lead to death in 30 to 50% of these cases. Management of these patients in this situation is based on supportive care and whole-brain radiotherapy. The place of chemotherapy for patients with good performance status was discussed for a long time and it is now admitted. However, the place of new drugs such as pemetrexed, which is currently used as a second line treatment for NSCLC, needs to be further studied. It is known that pemetrexed when added to cisplatin for treatment of NSCLC provides a similar effectiveness when compared to other drugs associations commonly used in this indication. In addition, Cisplatin with Pemetrexed probably present a better safety profile. The present study is based upon the hypothesis stipulating that the association cisplatin-pemetrexed will be at least as efficient as the others association currently used for treatment of NSCLC and will present a better safety profile. The primary objective of this study is overall response rate on brain metastasis according to RECIST criteria. Secondary judgment criterias are : Overall response rate, PFS after first-line CDDP plus pemetrexed, safety profile, quality of life, neurological symptoms, overall survival. The trial will enroll up to 45 patients in this single-arm two-stage sequential phase II study with the possibility of stopping the study early because of lack of efficacy.
Sponsor: University Hospital, Brest
Intervention: Pemetrexed, cisplatin
Start Date: 2008-09
Last Updated: 2009-07-28
Number of Patients: 45
Recruitment Status: COMPLETED
Condition: Lung Cancer

NCTID: NCT01361100 

Title: Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract
Study Summary: This is a multicentric feasibility study aimed to evaluate the Oncoral® test. The study includes 2 steps. The first one aims to validate the algorithm defined at the time when the test was developed in patients with different tumour stages. Patients will be enrolled before any treatment. They will immediately undergo the test. No follow-up will be realized. In total, 100 patients will be included in this first step. The estimated period of inclusion is 6 months. If the algorithm is validated, the second step of the study will start. The purpose is to determine the characteristics of the test. Enrollment will concern smokers and alcohol drinkers at high risk of developing an epidermoid carcinoma of the upper aerodigestive tract. Patient follow-up will vary with both the result of the test and the biopsy, up to a maximum of one year. In total, 385 patients will be enrolled in this step during an estimated period of 18 months.
Sponsor: Centre Leon Berard
Intervention: Oncoral® test
Start Date: 2010-12
Last Updated: 2012-10-02
Number of Patients: 485
Recruitment Status: UNKNOWN
Condition: Carcinoma

NCTID: NCT01583322 

Title: Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer
Study Summary: Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy. In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing. Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib). This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin & paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib).
Sponsor: ARCAGY/ GINECO GROUP
Intervention: vargatef
Start Date: 2012-06
Last Updated: 2023-09-06
Number of Patients: 188
Recruitment Status: COMPLETED
Condition: Ovarian Cancer

NCTID: NCT04713514 

Title: OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC
Study Summary: The proposed study is an international randomized phase II, multicenter, open-label, three arms trial to assess best supportive care (BSC) vs OSE2101 and vs OSE2101 + pembrolizumab as maintenance treatment for patients with platinum sensitive relapsed ovarian cancers, previously treated with chemotherapy (regardless of the number of prior lines of platinum-based chemotherapy), bevacizumab (if eligible) and a PARP inhibitor (if eligible). Patients in Complete Response, Partial Response, or Stable Disease at the end of chemotherapy with at least 4 cycles of platinum based chemotherapy will be randomized in one of the three arms (randomization 1:1:2). They will receive one or the two study treatments or BSC until progression, or intolerance, or up to 2 years (from 1st study treatment dose).
Sponsor: ARCAGY/ GINECO GROUP
Intervention: OSE2101
Start Date: 2021-08-05
Last Updated: 2023-09-05
Number of Patients: 180
Recruitment Status: RECRUITING
Condition: Platinum-sensitive Ovarian Cancer

NCTID: NCT05588700 

Title: Impact of a Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients
Study Summary: Testicular germ cell tumor (TGCT) is the most common malignancy in men between 15 and 40 years. Although TCGT survivors have a good survival prognosis, they suffer from short- and long-term sequelae such as chronic fatigue, psychological disorders, cardiovascular toxicities and second malignancies. The benefits of physical activity (PA) during treatments have been demonstrated in cancer patients to improve quality of life (QoL) and physical fitness and to reduce fatigue. However, few PA programs have been proposed to TGCT patients and their effects on sequelae have not been assessed yet. A growing body of evidence links treatment-related alteration in the gut microbiota to sequelae of cancer survivors, including fatigue and cardiovascular toxicities. Also, PA has been known as a possible modulator of the gut microbiota composition. To date, no study has been conducted to examine how the gut microbiota and its metabolites moderate the effect of PA on fatigue and other late effects in TGCT survivors. The objectives will be to assess the impact of a PA program on fatigue and other sequelae and to investigate how the gut microbiota and its metabolites moderate the associations between PA and sequelae. We will conduct a prospective, multicenter, phase III, randomized controlled trial of a one-year supervised PA program. 236 men with metastatic TGCT and eligible for a first line of chemotherapy will be randomly assigned to either PA intervention or control arm. All patients will benefit from a connected activity tracker and PA recommendations. In the intervention arm, PA will be based on supervised sessions and motivational interviews. The primary endpoint (fatigue) will be assessed at 3 years. The trial will provide novel insights into the impact of PA on fatigue and other sequelae in TGCT survivors with understanding a potential underlying mechanism of gut microbiota. This evidence will support the development of targeted PA guidelines to improve QoL and reduce sequelae in TGCT survivors.
Sponsor: Centre Leon Berard
Intervention: Physical activity recommendations
Start Date: 2023-09-30
Last Updated: 2023-08-30
Number of Patients: 236
Recruitment Status: NOT_YET_RECRUITING
Condition: Metastatic Testicular Cancer

NCTID: NCT04410185 

Title: Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology
Study Summary: The study is based on the realization of a meditation program associating patients, caregivers and control subjects
Sponsor: Centre Francois Baclesse
Intervention: Meditation
Start Date: 2020-09-10
Last Updated: 2021-03-04
Number of Patients: 31
Recruitment Status: COMPLETED
Condition: Cancer

NCTID: NCT04115007 

Title: Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients
Study Summary: INDICATION: Oligometastatic hormone-sensitive prostate cancer patients. METHODOLOGY: Open label, double arm, randomized 1:1, multicenter phase III study. PRIMARY OBJECTIVE: To assess the efficacy of ablative radiotherapy (SBRT applied to all oligometastases) administered to all gross tumor sites (metastases and prostate if applicable), in oligometastatic hormone-sensitive prostate cancer patients.
Sponsor: UNICANCER
Intervention: Stereotactic Body Radiotherapy (SBRT) + Standard of care
Start Date: 2020-06-23
Last Updated: 2023-02-17
Number of Patients: 350
Recruitment Status: RECRUITING
Condition: Oligometastatic Hormone Sensitive Prostate Cancer

NCTID: NCT02298283 

Title: Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD
Study Summary: This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin’s lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).
Sponsor: The Lymphoma Academic Research Organisation
Intervention: brentuximab vedotin
Start Date: 2015-04
Last Updated: 2021-07-26
Number of Patients: 40
Recruitment Status: COMPLETED
Condition: Hodgkin Lymphoma

NCTID: NCT00775307 

Title: Adjuvant Pazopanib in Stage I NSCLC
Study Summary: The aim of this study is to evaluate the efficacy and safety of pazopanib compared with placebo in patients with T < or = 5 cm, N0 (stage I according to TNM 2009) completely resected NSCLC.
Sponsor: Intergroupe Francophone de Cancerologie Thoracique
Intervention: PAZOPANIB
Start Date: 2008-11
Last Updated: 2019-09-24
Number of Patients: 142
Recruitment Status: COMPLETED
Condition: Carcinoma, Non-Small-Cell Lung

NCTID: NCT01900743 

Title: Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma
Study Summary: This is an international (France, Austria and Germany), randomized, double-blind, placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS) after failure or intolerance to doxorubicin (or other anthracycline). Five cohorts will be defined: Cohort A: Liposarcoma Cohort B: Leiomyosarcoma Cohort C: Synovial sarcoma Cohort D: other sarcomas (see Appendix C) Cohort E: Leiomyosarcoma, Synovial sarcoma and other sarcomas listed in Appendix C previously treated with pazopanib Approximately 226 patients who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment groups.
Sponsor: Centre Oscar Lambret
Intervention: Regorafenib
Start Date: 2013-06-05
Last Updated: 2021-04-09
Number of Patients: 219
Recruitment Status: COMPLETED
Condition: Sarcoma

NCTID: NCT06041607 

Title: Shared Meditation Involving People With Cancer, Carers and Third Parties
Study Summary: Although the benefits of meditation are increasingly well documented, few hospitals offer this integrative approach in their supportive cancer care. Meditation is sometimes provided, but its potential benefits remain insufficiently evaluated. This project is based on the hypothesis that there could be a benefit in meditating together.
Sponsor: Centre Francois Baclesse
Intervention: Shared meditation
Start Date: 2023-11
Last Updated: 2023-09-21
Number of Patients: 96
Recruitment Status: RECRUITING
Condition: Patients With Cancer

NCTID: NCT02867033 

Title: National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis (ALTITUDES)
Study Summary: The purpose of this study is to constitute the French largest Aggressive fibromatosis cohort.
Sponsor: Centre Oscar Lambret
Intervention: biopsy
Start Date: 2016-03-22
Last Updated: 2023-02-08
Number of Patients: 628
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: Aggressive Fibromatosis

NCTID: NCT01882933 

Title: D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma
Study Summary: A prospective, opened, multicentric, randomised, phase III trial with two arms: * Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin * Arm B: curative gastrectomy with D1-D2 lymph node dissection Main objective: Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology), treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy alone.
Sponsor: Hospices Civils de Lyon
Intervention: HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin
Start Date: 2013-06
Last Updated: 2023-04-19
Number of Patients: 367
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: Gastric Adenocarcinoma

NCTID: NCT01362933 

Title: National Evaluation of the Adherence to Recommendations of Venous Thrombo Embolism Treatment in Cancer Patients
Study Summary: Treatment of venous thromboembolism in cancer patients is specific and has been validated in trials that favor the use of LMWH (Low Molecular Weight Heparin) instead of VKA (Vitamin K Antagonist) treatment during 6 months. International recommendations have diffused this option.It is necessary to evaluate the compliance of physicians to this treatment by measuring the number of patients with cancer treated with long term use of LMWH.
Sponsor: Floralis
Intervention: VTE treatment in cancer patient description
Start Date: 2011-05
Last Updated: 2015-03-06
Number of Patients: 502
Recruitment Status: COMPLETED
Condition: Neoplasms

NCTID: NCT02046733 

Title: Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease
Study Summary: Despite the fact that the majority of the patients with limited disease SCLC will respond very well to the standard treatment, a great proportion will relapse within 12 - 24 months. Several studies in patients with lung cancer suggested a possible favourable association between the increased presence of immunologically active cells in the tumour and survival. Nivolumab and ipilimumab are proteins, which help your immune system to attack and destroy cancer cells by your immune cells. Early clinical trials with nivolumab and ipilimumab have shown activity in a broad range of cancers, including SCLC. The aim of the current study is to investigate the efficacy (how well the treatment works) and tolerability (how severe the side effects are) of the standard treatment (chemotherapy and radiotherapy) alone, compared with the standard treatment followed by nivolumab and ipilimumab in patients with limited SCLC.
Sponsor: ETOP IBCSG Partners Foundation
Intervention: Ipilimumab
Start Date: 2014-07-28
Last Updated: 2021-02-08
Number of Patients: 174
Recruitment Status: UNKNOWN
Condition: Limited Stage Small Cell Lung Cancer

NCTID: NCT04736485 

Title: Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT)
Study Summary: Multicenter, open-label, non randomized, phase 2 trial in resectable gastric or gastroesophageal junction adenocarcinoma: Perioperative Treatment by Spartalizumab (PDR001) in Combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT)
Sponsor: Centre Francois Baclesse
Intervention: perioperative treatment
Start Date: 2021-06-28
Last Updated: 2022-12-23
Number of Patients: 67
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: Gastric Cancer by AJCC V8 Stage

NCTID: NCT04584086 

Title: Changes in the MRI Signal in Patients With Benign Tumors of the Brain and Meninges Treated With Proton Therapy: Impact of TEL and the Biological Dose Received
Study Summary: The main objective is to detect with TESLA multiparametric 3 MRI, the MRI secondary changes to protontherapy irradiation and to correlate them with TEL mapping, physical dose and biological dose. A model should thus be able to be proposed at the end of the study.
Sponsor: Centre Francois Baclesse
Intervention: MRI 3 tesla
Start Date: 2021-04-22
Last Updated: 2023-03-08
Number of Patients: 20
Recruitment Status: COMPLETED
Condition: Benign Brain Tumors

NCTID: NCT05625087 

Title: Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib
Study Summary: After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was designed as a randomised, open-label, multicentre, phase II study, for comparison of alpelisib to ribociclib in combination with fulvestrant (as the continuation of the CDK4/6 inhibitor-fulvestrant strategy) in terms of progression-free survival (PFS).
Sponsor: UNICANCER
Intervention: Alpelisib
Start Date: 2023-10-19
Last Updated: 2023-11-22
Number of Patients: 162
Recruitment Status: RECRUITING
Condition: Breast Cancer Stage IV

NCTID: NCT02151214 

Title: Efficacy of Parenteral Nutrition in Patients at the Palliative Phase of Cancer.
Study Summary: In malnourished patients in the palliative phase of cancer, the question is raised of the relevance of implementing artificial nutritional assistance instead of oral feeding when this is possible. Medical prescription and implementation of artificial nutrition at this stage of the illness seem less governed by data acquired by science than by subjective reasons (related to beliefs, to a cultural or religious tradition, to the symbolic role of eating, to the deeply ingrained fear of dying of hunger, to a portrayal of care, etc.) while interacting with teams, the patient and his family and relatives. And yet, the benefits/risk balance and the effect on quality of life of parenteral nutrition in a palliative situation for patients presenting with a normal alimentary tract is poorly understood. The discomfort and risks of central venous or nasogastric artificial nutrition require that the benefits of artificial nutrition be proven. The nature of these benefits relate first and foremost to the quality of life experienced by the patient in such a context. Only a controlled randomized study may lead to an optimal palliative nutritional management of undernutrition to be determined, and to inform the patient and his/her relatives clearly in order for them to express their preferences. We hypothesize that abstaining from artificial parenteral central venous nutrition and associated hydration for nutritional purposes improves quality of life without significant loss of survival compared to implementing artificial nutrition, when considered, in the absence of any specific curative treatment in anorexic patients in the palliative phase of cancer. To test this hypothesis, we propose to carry out a multicenter, prospective, controlled, randomized study in order to evaluate the efficacy of implementing parenteral nutrition compared to abstaining from doing so on the quality of life of undernourished patients in the palliative phase of cancer. The effect on overall survival and the nutritional parameters will be evaluated. The ALIM K trial will be carried out in 13 centres specializing in supportive and onco-hematology care .
Sponsor: Centre Hospitalier Universitaire de Besancon
Intervention: Parenteral nutrition
Start Date: 2012-07-27
Last Updated: 2018-09-17
Number of Patients: 106
Recruitment Status: COMPLETED
Condition: Nutrition Aspect of Cancer

NCTID: NCT02558907 

Title: Comparison of MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) in Cognitive Assessment in Geriatric Oncology
Study Summary: Compare neurocognitive testing MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) to candidates aged patients with 1st line treatment of their cancer will be received an examination oncogériatric
Sponsor: Centre Francois Baclesse
Intervention: cognitive evaluation by MMS (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) tests
Start Date: 2015-09
Last Updated: 2017-04-04
Number of Patients: 66
Recruitment Status: COMPLETED
Condition: Geriatrics

NCTID: NCT02947685 

Title: Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer
Study Summary: The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
Sponsor: Alliance Foundation Trials, LLC.
Intervention: palbociclib
Start Date: 2017-06-21
Last Updated: 2023-05-30
Number of Patients: 496
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: HER-2 Positive Breast Cancer

NCTID: NCT04764487 

Title: A Web-mediated Follow-up With the Web-application KidneyPRO Versus Standard Follow-up for Patients With Advanced Renal Cell Carcinoma Treated With Axitinib/Pembrolizumab in First Line
Study Summary: With the advent of immunotherapy, standard first-line treatment for patients with renal cell carcinoma is now an association with an immune checkpoint inhibitor. In this context, the association axitinib plus pembrolizumab has already been evaluated in several studies with positive results for Progression Free survival, Overall survival and Complete response. The combo received a positive opinion from the Committee for Medicinal Products for Human Use, and the European Commission approves the extension of Marketing Authorization in first line for metastatic renal cell carcinoma patients. In a context of treatment with a new association, it is important to manage the toxicities closely in order to allow the patients to have an optimal treatment. The underlying hypothesis is that the use of new information and communication technologies could improve clinical patient management. In this study, we wish assess the impact of monitoring via the web application KidneyPRO on the quality of life of patients with the new combination of treatment axitinib/pembrolizumab for a renal cell carcinoma in first line.
Sponsor: Weprom
Intervention: KidneyPRO
Start Date: 2021-06-07
Last Updated: 2022-05-03
Number of Patients: 178
Recruitment Status: RECRUITING
Condition: Renal Cell Carcinoma Metastatic

NCTID: NCT04262687 

Title: Chemotherapy and Immunotherapy as Treatment for MSS Metastatic Colorectal Cancer With High Immune Infiltrate
Study Summary: About 85% of cases of non-metastatic colorectal cancer (CRC) are related to chromosomal instability and have a proficient DNA Mismatch-Repair system (pMMR); which are also called CRC with microsatellite stability (MSS). Other CRC, i.e. 15%, are “microsatellite unstable” (MSI) with deficient DNA Mismatch-Repair system (dMMR). These latter are characterised by generation of many neo-antigens, which result in a high anti-tumour immune response and a high peri- and/or intra-tumour lymphocyte infiltration (TIL). Investigators recently showed, with a prospectively validated immune score, that 14% of localised MSS/pMMR CRC are also highly infiltrated by CD3+ lymphocytes. This same immune score has made it possible to measure high lymphocyte infiltration in hepatic metastases, in particular, in patients treated with XELOX/FOLFOX. Pembrolizumab, an anti-PD1 monoclonal antibody (programmed death-1) is an immune checkpoint inhibitor (ICI) of PD1/PD-L1 axis, recently approved in many cancers. Anti-PD1 antibodies have recently been reported as being very effective in patients with dMMR metastatic CRC (mCRC). In the study by Le DT et al. pMMR mCRC did not seem to benefit from anti-PD1 antibodies. However, it is possible that 20% of pMMR mCRC with a high CD3+ infiltrate in the tumour may be a subgroup of pMMR mCRC sensitive to ICI, as is the case for dMMR mCRC. Lastly, immunogenic cell death induced by chemotherapy, such as oxaliplatin, can increase the efficacy of ICI. The prognostic value of lymphocyte infiltrate has been demonstrated in CRC by several teams. However, no validated test is used in routine clinical practice. Previously, investigators described an automated and reproducible method for analysis of TIL and investigators validated it for clinical use. Automated tests evaluating TIL are performed on virtual slides and have showed that, out of 1,220 tumours tested, 20% were highly infiltrated by CD3+ T cells. Patients presenting with a pMMR CRC with a high immune infiltrate had a better progression-free survival (HR=0.70; p=0.02). An immunoscore® described by Galon et al. has also a high prognostic value in CRC and is based on CD3+ and CD8+ T cells infiltration in the center and periphery of the tumour. Finally, approximately 14% of tumours with a high immune infiltrate have been found in patients with metastatic CRC. Investigators formulated the hypothesis that patients with a pMMR CRC with a high immune infiltrate can be sensitive to ICI . Therefore, blocks of resected primary tumour will be collected and analysed prospectively. For each patient, slides containing tumour tissue and adjacent non-tumour tissue will be analysed using two techniques : immunoscore® and TuLIS score.It consist in Immunohistochemistry with CD3 and CD8 staining. Slides will be scanned and analysed by image analysis as previously described . Tumours will then be classified as having a “high” or “low” immune response according to type of lymphocyte infiltrate, which is independent of pre-analytic conditions. Only patients with a high immune response will be eligible for the POCHI trial. Other biomarkers will be analysed like other immune populations or mutational load. If investigators identify an immune score which seems clinically relevant to predict sensitivity to ICI in pMMR mCRC, this will make it possible to plan a randomised phase III trial comparing chemotherapy and anti-angiogenic antibody versus chemotherapy and anti-angiogenic antibody plus pembrolizumab in patients with a pMMR mCRC with a high immune score and/or a hypermutated genotype. Investigators choose PFS at 10 months as primary endpoint in POCHI trial because it is a surrogate marker of OS. Actually median PFS in first-line setting with a doublet plus a biological agent is range from 8 to 11 months in unresectable mCRC, corresponding to a PFS of 50% at 10 months. The alternative clinical hypothesis to obtain 70% of patients alive and without progression at 10 months is ambitious and currently not achieved with current chemotherapies plus a biological agent. Up until now there is no data concerning survivals outcomes of patients with a MSS mCRC with high immune infiltration score.
Sponsor: Federation Francophone de Cancerologie Digestive
Intervention: Capecitabine
Start Date: 2021-04-06
Last Updated: 2023-08-18
Number of Patients: 55
Recruitment Status: RECRUITING
Condition: Colorectal Cancer Metastatic

NCTID: NCT01358747 

Title: Study of a Treatment Driven by Early PET Response to a Treatment Not Monitored by Early PET in Patients With AA Stage 3-4 or 2B HL
Study Summary: All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is hoped that patients will achieve a good response to both induction therapies consisting either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD (Adriamycine, Bléomycine, Vinblastine, Décarbazine). The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2) in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc therapy continuation to those patients who achieved only a partial response after 2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2 negative patients. For all patients included in the trial the achievement of a good response to induction treatment will be checked after four cycles of induction treatment including a centrally reviewed PET assessment Patients will be randomized after verification of eligibility and before the start of the protocol treatment.Patients will be randomly assigned to the standard treatment arm not monitored by early PET, or the experimental treatment arm driven by the PET2 result.
Sponsor: Centre Hospitalier Universitaire Dijon
Intervention: BEACOPPesc
Start Date: 2011-05
Last Updated: 2014-05-21
Number of Patients: NA
Recruitment Status: COMPLETED
Condition: Hodgkin’s Lymphoma

NCTID: NCT05102747 

Title: Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (310 Gy) to the Historical Single-dose Radiosurgery (120 to 25 Gy) With Medico-economic Evaluation.
Study Summary: Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of “oligometastatic” cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible. Stereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature. HSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation. Common adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment. To investigators knowledge, SRS and HSRT have not been prospectively compared.
Sponsor: Centre Francois Baclesse
Intervention: Hypofractionated SRT (stereotactic radiotherapy)
Start Date: 2022-06-29
Last Updated: 2022-08-10
Number of Patients: 504
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: Brain Metastasis

NCTID: NCT03745950 

Title: UTOLA: UTerin OLAparib
Study Summary: This is a phase IIB, national, randomized, double-blinded, comparative, multi-center study, to assess the efficacy of Olaparib as maintenance after a platinum based chemotherapy in patients with Advanced or metastatic endometrial cancer
Sponsor: ARCAGY/ GINECO GROUP
Intervention: Olaparib Oral Capsule
Start Date: 2019-02-01
Last Updated: 2023-11-07
Number of Patients: 147
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: Endometrial Carcinoma

NCTID: NCT04366154 

Title: Impact of the COVID-19 Infectious Epidemic on the Management of Oncology and Onco-hematology Patients and on the Psychological Consequences for Patients and Caregivers
Study Summary: This original study will assess the impact of the coronavirus health crisis on the management of patients undergoing medical treatment for cancer, in particularly on the modification of the hospital organization. It will also provide a record of the progress of patients who will have been treated during the epidemic period and infected by the virus. We will also assess the psychological impact of the pandemic in patients but also in caregivers
Sponsor: Centre Francois Baclesse
Intervention: Questionnaire
Start Date: 2020-04-15
Last Updated: 2020-12-14
Number of Patients: 809
Recruitment Status: UNKNOWN
Condition: COVID-19

NCTID: NCT01641497 

Title: Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer
Study Summary: Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years with a endometrial cancer.
Sponsor: Centre Oscar Lambret
Intervention: 3D conformational radiation
Start Date: 2012-05
Last Updated: 2017-07-21
Number of Patients: 26
Recruitment Status: TERMINATED
Condition: Endometrial Cancer

NCTID: NCT03301454 

Title: Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer
Study Summary: Phase II study, randomized, open-label, multicentric, willing to establish the benefit of pursuing chemotherapy beyond 6 weeks for non progressive patients. The study will proceed in two successive phases : * non randomized phase in which all patients will undergo chemotherapy * second phase in which only non progressive patients are going to be randomized (“discontinuation design”). Patients that will show progression in their disease during the first 6 weeks will be released of the study
Sponsor: Centre Oscar Lambret
Intervention: pursuit of chemotherapy
Start Date: 2018-09
Last Updated: 2018-08-08
Number of Patients: 80
Recruitment Status: UNKNOWN
Condition: Esophageal Cancer, Squamous Cell

NCTID: NCT01850303 

Title: Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer
Study Summary: For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is better than monotherapy in term of overall survival and progression free survival. The current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles). After the treatment is stopped until progression and initiation of a second line treatment. The risk of this strategy is to be confronted to a rapid disease progression during the free interval. Indeed, about 1/3 of the patients whose disease was controlled after the chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of 1st line (induction chemotherapy). There is two types of maintenance : * continuous maintenance therapy which consists in continuing the treatment initially associated with platinum until disease progression. * switch maintenance which consists in introducing a new treatment after the end of induction chemotherapy The two types are validated by several trials. The marketing authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma. Gemcitabine has a good tolerance profile which make possible the use in a maintenance strategy. Several trials evaluated maintenance with this product and some show benefits in term of progression free survival. The objective of this trial is to evaluate the switch maintenance in elderly patient with a controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.
Sponsor: Intergroupe Francophone de Cancerologie Thoracique
Intervention: Pemetrexed
Start Date: 2013-05-16
Last Updated: 2023-03-14
Number of Patients: 632
Recruitment Status: COMPLETED
Condition: Non Small Cell Lung Cancer (Squamous or Non Squamous)

NCTID: NCT02271659 

Title: Medical and Economic Evaluation for Intermediate-risk Prostate Cancer
Study Summary: The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment. The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.
Sponsor: Hospices Civils de Lyon
Intervention: Brachytherapy boost with external beam radiotherapy
Start Date: 2013-06
Last Updated: 2016-09-13
Number of Patients: 298
Recruitment Status: UNKNOWN
Condition: Prostate Cancer

NCTID: NCT04747054 

Title: Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers
Study Summary: Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head & neck cancers
Sponsor: UNICANCER
Intervention: Pembrolizumab
Start Date: 2021-12-01
Last Updated: 2023-10-13
Number of Patients: 148
Recruitment Status: RECRUITING
Condition: Squamous Cell Carcinoma of Head and Neck

NCTID: NCT03169075 

Title: QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program
Study Summary: This phase II-III study will be randomized (2:1) patients starting first-line oral targeted therapies (OTT) for metastatic cancer between an individualized supervised physical exercise programs (SPEP) by a personal coach, and recommended physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic chemotherapy, Eastern Cooperative Oncology Group Performance status (ECOG PS) ≤2, controlled pain (visual analogue scale (VAS) <3/10), and life expectancy ≥3 months.
Sponsor: UNICANCER
Intervention: Supervised physical exercise programs
Start Date: 2017-07-11
Last Updated: 2023-11-08
Number of Patients: 190
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: Home Based Standardised Adapted Physical Activity Programme

NCTID: NCT00535275 

Title: NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy
Study Summary: Relapses after perioperative chemotherapy and surgery
Sponsor: Intergroupe Francophone de Cancerologie Thoracique
Intervention: Chemotherapy with platine
Start Date: 2007-09
Last Updated: 2015-02-16
Number of Patients: 88
Recruitment Status: TERMINATED
Condition: Carcinoma, Non-Small-Cell Lung

NCTID: NCT02871167 

Title: Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation
Study Summary: The aim of the study is to perform a French multicenter prospective interventional study in order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo cryopreservation in young women with breast cancer. The oncologic and reproductive benefit / risk ratio will be investigated in the oncology and reproductive area.
Sponsor: Centre Oscar Lambret
Intervention: Controlled ovarian hyperstimulation (COH)
Start Date: 2016-12
Last Updated: 2023-02-14
Number of Patients: 120
Recruitment Status: RECRUITING
Condition: Breast Cancer

NCTID: NCT01564056 

Title: Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment
Study Summary: The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall survival for elderly patients with breast cancer, in a sub group with a high risk of relapse according to Genomic Grade test.
Sponsor: UNICANCER
Intervention: HORMONOTHERAPY
Start Date: 2012-04-12
Last Updated: 2023-04-06
Number of Patients: 1989
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: Breast Cancer

NCTID: NCT00651456 

Title: Mesothelioma Avastin Plus Pemetrexed-cisplatin Study
Study Summary: Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.
Sponsor: Intergroupe Francophone de Cancerologie Thoracique
Intervention: Standard Chemotherapy (Pemetrexed and Cisplatin)
Start Date: 2008-02
Last Updated: 2023-03-13
Number of Patients: 448
Recruitment Status: COMPLETED
Condition: Mesothelioma

NCTID: NCT01844986 

Title: Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Study Summary: Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
Sponsor: AstraZeneca
Intervention: Olaparib 300mg tablets
Start Date: 2013-08-26
Last Updated: 2023-11-28
Number of Patients: 450
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: Newly Diagnosed

NCTID: NCT04704219 

Title: Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)
Study Summary: This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma.
Sponsor: Merck Sharp & Dohme LLC
Intervention: Pembrolizumab
Start Date: 2021-02-23
Last Updated: 2023-08-29
Number of Patients: 152
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: Renal Cell Carcinoma

NCTID: NCT04949256 

Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Sponsor: Merck Sharp & Dohme LLC
Intervention: Pembrolizumab
Start Date: 2021-07-28
Last Updated: 2023-11-24
Number of Patients: 862
Recruitment Status: RECRUITING
Condition: Metastatic Esophageal Squamous Cell Carcinoma

NCTID: NCT02383251 

Title: Paclitaxel/Pazopanib for Platinum Resistant/Refractory Ovarian Cancer
Study Summary: Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance.
Sponsor: ARCAGY/ GINECO GROUP
Intervention: Pazopanib
Start Date: 2015-06-15
Last Updated: 2023-09-06
Number of Patients: 118
Recruitment Status: COMPLETED
Condition: Ovarian Cancer

NCTID: NCT00547651 

Title: AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy
Study Summary: This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer.
Sponsor: Celgene
Intervention: Amrubicin
Start Date: 2007-09-01
Last Updated: 2019-11-06
Number of Patients: 637
Recruitment Status: COMPLETED
Condition: Small Cell Lung Cancer

NCTID: NCT00932451 

Title: An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
Study Summary: This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.
Sponsor: Pfizer
Intervention: PF-02341066
Start Date: 2010-01
Last Updated: 2017-01-13
Number of Patients: 1069
Recruitment Status: COMPLETED
Condition: Carcinoma, Non-Small-Cell Lung

NCTID: NCT04300556 

Title: A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types
Study Summary: The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer <math display="block">OC</math>, endometrial cancer <math display="block">EC</math>, non-small cell lung carcinoma <math display="block">NSCLC</math>, triple-negative breast cancer <math display="block">TNBC</math>), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A <math display="block">OC and EC participants</math> and Part B <math display="block">EC only</math>): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the use of the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days, as mitigation strategy for interstitial lung disease (ILD); and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to further evaluate the safety, tolerability and preliminary efficacy of 2 treatment regimens with farletuzumab ecteribulin (MORAb-202) in participants with advanced EC and to determine the recommended treatment regimen for further development of farletuzumab ecteribulin (MORAb-202).
Sponsor: Eisai Inc.
Intervention: Farletuzumab ecteribulin
Start Date: 2020-08-06
Last Updated: 2023-11-01
Number of Patients: 142
Recruitment Status: RECRUITING
Condition: Solid Tumor

NCTID: NCT05201547 

Title: Endometrial Cancer Patientes MMR Deficient Comparing Chimiotherapy vs Dostarlimab in First Line
Study Summary: Phase 3, randomized, multicentre study to evaluate the efficacy and safety of dostarlimab versus carboplatin-paclitaxel in patients with MMR deficient relapse or advanced endometrial cancer.
Sponsor: ARCAGY/ GINECO GROUP
Intervention: Carboplatin-Paclitaxel
Start Date: 2022-04-15
Last Updated: 2023-07-27
Number of Patients: 260
Recruitment Status: RECRUITING
Condition: Endometrial Cancer

NCTID: NCT01460186 

Title: Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer
Study Summary: This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify germ line genetic factors that influence the risk of metastatic breast cancer. 1500 patients will be enrolled in this study. Blood samples will be collected after informed consent and inclusion in the study. Patients will be treated and followed according to the standards of their treating center. They will be followed during at least 5 years every 6 months for 3 years then every year.
Sponsor: Centre Leon Berard
Intervention: Blood sample for genetic analysis (Identification of germ line genetic factors that influence the risk of metastatic breast cancer)
Start Date: 2011-12
Last Updated: 2019-01-15
Number of Patients: 1000
Recruitment Status: COMPLETED
Condition: Breast Cancer

NCTID: NCT02880943 

Title: Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL)
Study Summary: This is a prospective, multicentre, open-label, phase I/II study to evaluate the maximum tolerated dose (MTD), and the most successful dose (MSD) of XOFIGO®, in renal cancer patients with metastases to bone, without (Group A) or with (Group B) visceral metastases.
Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Intervention: XOFIGO
Start Date: 2016-10
Last Updated: 2016-11-08
Number of Patients: 42
Recruitment Status: UNKNOWN
Condition: Clear-cell Metastatic Renal Cell Carcinoma

NCTID: NCT00446225 

Title: Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR
Study Summary: A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK) domain of the EGFR.
Sponsor: Spanish Lung Cancer Group
Intervention: Erlotinib
Start Date: 2007-02
Last Updated: 2022-06-13
Number of Patients: 174
Recruitment Status: COMPLETED
Condition: Non-Small Cell Lung Cancer

NCTID: NCT05874492 

Title: Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Postoperative Radiotherapy for Breast Cancer
Study Summary: FIBROTHERME is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial. The aim of this study is to evaluate the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis 6 months after a dermatologically oriented spa therapy in patients with severe late reactions affecting the skin and/or soft tissues at least 6 months after the end of postoperative radiotherapy for breast cancer.
Sponsor: Association Francaise pour la Recherche Thermale
Intervention: Thermal cure with a primary dermatological indication
Start Date: 2023-09
Last Updated: 2023-06-22
Number of Patients: 110
Recruitment Status: NOT_YET_RECRUITING
Condition: Fibrosis

NCTID: NCT04597125 

Title: Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH
Study Summary: Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer. Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain.
Sponsor: Bayer
Intervention: Radium-223 dichloride (Xofigo, BAY88-8223)
Start Date: 2020-11-09
Last Updated: 2023-11-14
Number of Patients: 696
Recruitment Status: RECRUITING
Condition: Metastatic Castrate Resistant Prostate Cancer (mCRPC)

NCTID: NCT03818386 

Title: Radiotherapy of Multiple Brain Metastases Using AGuIX®
Study Summary: This is a Prospective Randomized Open Blinded Endpoint phase II clinical trial. The study will be adaptive: an interim analysis is planned after enrolment of 20 patients in each arm of treatment (WBRT and AGuIX® + WBRT), to select and continue the study with group(s) that present the best response rate to the experimental treatment (AGuIX® + WBRT). The main endpoint will be evaluated by a blinded endpoint committee.
Sponsor: University Hospital, Grenoble
Intervention: AGuIX®
Start Date: 2019-03-26
Last Updated: 2023-08-18
Number of Patients: 100
Recruitment Status: RECRUITING
Condition: Brain Metastases, Adult

NCTID: NCT06011525 

Title: Prevention of Alopecia in Patients With Localised Breast Cancer
Study Summary: The prevention of chemotherapy-induced alopecia (CIA) is still imperfectly managed in France. Strengthening the evidence base on the benefits of strategies to prevent CIA, based on robust methodologies, remains a prerequisite for better integration of appropriate supportive care for patients receiving chemotherapy. This research should provide new knowledge on the benefits of scalp refrigeration during anthracycline- and taxane-based chemotherapy in preventing ACI, for each of the 2 refrigeration techniques. In addition to effectiveness in preventing ACI, quality of life, self-image and satisfaction with care will be assessed by patients during and after chemotherapy. The medico-economic aspects will also be assessed for each of the two refrigeration modalities. The results of the various proposed assessments will be used to guide the choice between these two techniques for preventing ACI.
Sponsor: Centre Francois Baclesse
Intervention: standard cold cap
Start Date: 2023-08-03
Last Updated: 2023-08-25
Number of Patients: 196
Recruitment Status: RECRUITING
Condition: Chemotherapy-induced Alopecia

NCTID: NCT01578655 

Title: Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer
Study Summary: This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms.
Sponsor: Achieve Life Sciences
Intervention: cabazitaxel
Start Date: 2012-08
Last Updated: 2016-10-12
Number of Patients: 630
Recruitment Status: COMPLETED
Condition: Prostate Cancer

NCTID: NCT03663725 

Title: Treatment Intensification With Temozolomide in Adults With a Glioblastoma
Study Summary: Due to conflicting data on the optimal moment to start TMZ chemotherapy and the impact of prolongation of the adjuvant phase with TMZ, the ANOCEF (Association des Neuro-Oncologues d’Expression Francophone) group proposes this randomized trial comparing an intensified arm (early TMZ and extended adjuvant TMZ until toxicity, progression or patient refusal) versus the classical EORTC regimen as control (RT and concomitant TMZ started 4-6 weeks after surgery followed by a number of adjuvant TMZ cycles strictly limited to 6) for primary GBM adult patients.
Sponsor: Centre Oscar Lambret
Intervention: Intensified protocol
Start Date: 2019-03-13
Last Updated: 2022-07-20
Number of Patients: 486
Recruitment Status: RECRUITING
Condition: Glioblastoma

NCTID: NCT02438007 

Title: A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC
Study Summary: The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).
Sponsor: LTN PHARMACEUTICALS, INC.
Intervention: Galeterone
Start Date: 2015-06
Last Updated: 2023-03-15
Number of Patients: 953
Recruitment Status: TERMINATED
Condition: Prostate Cancer

NCTID: NCT02797405 

Title: Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay
Study Summary: THEODORA is a prospective pilot clinical trial aiming at first to evaluate and validate the predictive value of the A & MS bioassays on tumor control by radiotherapy.
Sponsor: Centre Leon Berard
Intervention: Standard treatment
Start Date: 2016-10
Last Updated: 2020-03-25
Number of Patients: 97
Recruitment Status: TERMINATED
Condition: Sarcoma

NCTID: NCT05241405 

Title: Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer
Study Summary: This is a multicenter randomized trial in breast cancer patients reporting cancer-related fatigue to evaluate the efficacy and safety of Qiseng® based on extract of American ginseng combined with vitamin C from extract of Camu Camu berries
Sponsor: Centre Francois Baclesse
Intervention: QISENG
Start Date: 2022-09-27
Last Updated: 2023-11-13
Number of Patients: 354
Recruitment Status: RECRUITING
Condition: Breast Cancer

NCTID: NCT01206205 

Title: Frontline Therapy in de Novo Multiple Myeloma Patients Under 65
Study Summary: The purpose of this Phase 2 study is to evaluate the efficacy and safety of treatment with bortezomib, lenalidomide and dexamethasone in patients with untreated multiple myeloma. This study will evaluate whether the addition of lenalidomide to bortezomib and dexamethasone will increase the Complete Response (CR)/ very good partial response (VGPR) rate before and after High Dose Therapy (HDT) with ASCT.
Sponsor: University Hospital, Toulouse
Intervention: Lenalidomide, Bortezomib
Start Date: 2009-08
Last Updated: 2017-05-12
Number of Patients: 31
Recruitment Status: COMPLETED
Condition: Multiple Myeloma

NCTID: NCT03473652 

Title: Feasibility of Adapted Physical Activity Based on a Walking Platform in Hospitalized Old Patients for Cancer
Study Summary: The investigator propose to evaluate the interest of the provision of a suitable treadmill offering fall protection and verticalization assistance.
Sponsor: Centre Francois Baclesse
Intervention: Adapted walking platform
Start Date: 2018-05-29
Last Updated: 2019-01-16
Number of Patients: 45
Recruitment Status: COMPLETED
Condition: Oncology

NCTID: NCT02323568 

Title: Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs.
Study Summary: This project is part of a large multicenter multidisciplinary program that will thoroughly explore the needs and difficulties of patients with BCR as well as those involved in their care. The results of this research program will propose recommendations for better structure and understand the follow up of these patients. From the limited data in the literature, the long-term remission in patients with ovarian cancer reported a significant and persistent fatigue, poor QoL, disorders of sexuality as well as somatic and mental illness; consumption is also a medical records for these patients. In this context, our team has initiated a large case-control study to assess fatigue (identified major problem in the long-term remission in patients with ovarian cancer), QoL and rehabilitation of patients in remission from an epithelial ovarian cancer (regardless of the stage of cancer at diagnosis, early or advanced) 3 years after the initial treatment, compared with women of the same age without ovarian cancer or serious chronic disease , from the general population. Patients and controls complement standardized and validated self-administered questionnaire (part 1). This study investigated 215 patients in long remission from ovarian cancer compared to 215 women of the same age without cancer. Recruitment of patients is currently underway, in close collaboration with teams from the Group GINECO very involved in this project. Following this step, an additional component is planned: it is to offer patients who participated in part 1, a specific gynecological consultation to assess in detail the effects of the treatments in order to better meet the needs of patients .dropoff window
Sponsor: Centre Francois Baclesse
Intervention: Gynecological consultation
Start Date: 2014-12
Last Updated: 2017-02-10
Number of Patients: 179
Recruitment Status: COMPLETED
Condition: Epithelial Ovarian Cancer

NCTID: NCT03324282 

Title: First-line Gemcitabine/Cisplatin +/- Avelumab in Locally Advanced or Metastatic Bladder Carcinoma
Study Summary: This study will assess efficacy (based on response rate) and safety (based on grade ≥ 3 severe adverse effects) of the combination Gemcitabine Cisplatin (GC) + anti-PD-L1 (avelumab) in first-line treatment for locally advanced or metastatic urothelial bladder cancer patients, after 6 cycles of treatment (or at 18 weeks if less than 6 cycles have been given, or earlier if a second line treatment is needed, before this new anticancer treatment has been started).
Sponsor: University Hospital, Bordeaux
Intervention: Avelumab
Start Date: 2018-02-23
Last Updated: 2022-05-03
Number of Patients: 65
Recruitment Status: TERMINATED
Condition: Bladder Carcinoma

NCTID: NCT00397345 

Title: TroVax Renal Immunotherapy Survival Trial
Study Summary: The purpose of this study is to investigate whether TroVax, when added to first line standard of care therapy, improves survival for patients with locally advanced or metastatic clear cell renal adenocarcinoma.
Sponsor: Oxford BioMedica
Intervention: Trovax
Start Date: 2006-09
Last Updated: 2020-10-19
Number of Patients: 733
Recruitment Status: COMPLETED
Condition: Clear Cell Renal Carcinoma

NCTID: NCT03752216 

Title: NIraparib and Quality Of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib.
Study Summary: This is a longitudinal, national, open, multi-centre phase IV study which will recruit up to 141 patients with ovarian cancer in late relapse treated with niraparib according to the labelling In France.
Sponsor: ARCAGY/ GINECO GROUP
Intervention: Niraparib
Start Date: 2019-04-03
Last Updated: 2023-09-06
Number of Patients: 141
Recruitment Status: COMPLETED
Condition: Ovarian Cancer

NCTID: NCT06036706 

Title: Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma
Study Summary: For the purpose of this research, investigator will constitute several cohorts of patients, treated either by intensity-modulated radiotherapy, stereotactic radiotherapy or proton-therapy. This will allow better understanding the cognitive and anatomical damages caused by new radiotherapy techniques and better understanding how ionising radiation (X-rays or protons) acts in the long term on brain tissue. Longitudinal follow-up will be multimodal, based on yearly multi-parametric brain MRI to assess morphological changes, in relation with dosimetric data as well as neuropsychological performances, health-related quality of life, anxiety and depression disorders, memory tasks, and socio-professional reintegration. This will notably make it possible to evaluate the relationship between dosimetric data, age at the time of treatment, region of the brain irradiated, type of radiation used, dose per fraction, neurocognitive and neuro-anatomical consequences. A Normal Tissue Control Probability (NTCP) model will be also developed. Overall, the results of this study should contribute to the improvement of treatment techniques, in particular by preserving as much as possible the significant cerebral zones (hippocampi, frontal lobe, sub-ventricular zones, etc.), and to the management of patients by proposing appropriate support measures. In the proton-therapy cohort, evaluations will make it possible to establish more precisely the place that this new irradiation strategy should occupy in the management of low grade meningioma. Importantly, investigator have planned to constitute a last cohort, with subjects free of any neurological disease, to make it easier the interpretation of cognitive performances over time among patients in the three brain radiation cohorts.
Sponsor: Centre Francois Baclesse
Intervention: Normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning
Start Date: 2023-09-13
Last Updated: 2023-09-14
Number of Patients: 108
Recruitment Status: RECRUITING
Condition: Meningioma

NCTID: NCT04348045 

Title: Phase II Study to Evaluate MAintenance Therapy With Olaparib or Selumetinib Plus Durvalumab According to BRCAness and KRAS Somatic Status Personalized in Metastatic Pancreatic Adenocarcinoma Patients
Study Summary: MAZEPPA is open-label, phase II study to assess the efficacy of a genomic-driven maintenance therapy in terms of PFS in Pancreatic ductal adenocarcinoma (PDAC) patients with disease controlled after 4 months of mFOLFIRINOX chemotherapy as following: Patients with a BRCAness somatic profile: olaparib Arm A. Patients with no BRCAness profile and with KRAS mutation randomization between durvalumab plus selumetinib Arm B, versus FOLFIRI Arm C.
Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Intervention: Arm A - Olaparib
Start Date: 2020-12-07
Last Updated: 2023-03-07
Number of Patients: 307
Recruitment Status: RECRUITING
Condition: Metastatic Pancreatic Adenocarcinoma

NCTID: NCT02730416 

Title: Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer
Study Summary: This study will evaluate the role of addition of an anti-angiogenic agent (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance treatment in primary advanced or with first relapse of endometrial cancer.
Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Intervention: Nintedanib or Placebo; Carboplatin, Paclitaxel
Start Date: 2016-12-12
Last Updated: 2023-09-21
Number of Patients: 146
Recruitment Status: COMPLETED
Condition: Endometrial Cancer

NCTID: NCT01613482 

Title: TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention
Study Summary: Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.
Sponsor: Centre Oscar Lambret
Intervention: cerebral prophylactic radiation
Start Date: 2007-10
Last Updated: 2012-06-07
Number of Patients: 13
Recruitment Status: TERMINATED
Condition: Breast Cancer

NCTID: NCT04547504 

Title: PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 %
Study Summary: PERSEE is a French national phase 3 academic study comparing the chemotherapy-pembrolizumab combination to pembrolizumab alone as a first-line treatment for advanced NSCLC molecularly defined by a PDL1 expression ≥ 50% of tumour cells and no EGFR mutations or ALK rearrangement. The main hypothesis is the superiority of the chemo-immunotherapy combination over mono-immunotherapy in terms of progression-free survival evaluated by an independent review committee. One of the anticipated benefits of using the chemotherapy-pembrolizumab combination starting from the first line setting for NSCLC patients with PD L1 ≥ 50% is a reduced risk of early progression, which is known to occur with pembrolizumab monotherapy, and therefore, a better PFS.
Sponsor: University Hospital, Brest
Intervention: Pembrolizumab
Start Date: 2020-12-22
Last Updated: 2021-03-12
Number of Patients: 292
Recruitment Status: RECRUITING
Condition: Non-small-cell Lung Cancer

NCTID: NCT02364206 

Title: Study of LY2228820 With Radiotherapy Plus Concomitant TMZ in the Treatment of Newly Diagnosed Glioblastoma
Study Summary: Glioblastomas are extremely resistant to treatment, including radiotherapy and/or chemotherapy. Mitogen-activated protein kinase (MAPK) cascades are key signaling pathways involved in the regulation of normal cell proliferation, survival and differentiation. Activation of p38 MAPK has been associated with a poor prognosis among patients with glioblastoma during the temozolomide (TMZ) era and represents a compensatory response by tumor cell to environmental stress such as radiation or chemotherapy. LY2228820 is a potent and selective inhibitor of p38 MAPK, and reduces phosphorylation of its cellular target, MAPK-activated protein kinase 2 (MAPKAPK-2) . LY2228820 is a good candidate to target malignant glioma resistance to the gold standard treatment combining radiation and TMZ by acting on both tumor and stromal cells. The primary objectives of this study were to determine the recommended dose of LY2228820 in combination with TMZ and radiotherapy during chemoradiotherapy period (phase I) and to estimate the 6-month progression free survival (PFS) rate of patients treated with LY2228820 when administered at the recommended dose in combination with radiotherapy and concomitant TMZ (phase II)
Sponsor: Centre Jean Perrin
Intervention: LY2228820
Start Date: 2015-06-08
Last Updated: 2019-08-14
Number of Patients: 18
Recruitment Status: COMPLETED
Condition: Adult Glioblastoma

NCTID: NCT03670927 

Title: Etiosarc: Environmental Aetiology of Sarcomas From a Multicenter French Population-based Case-control Study Among Adults
Study Summary: Introduction: Sarcomas are rare tumors of connective tissue. The exact overall incidence of sarcomas is unknown due to diagnostic difficulties and the various histological subtypes (over 80 subtypes). However, the apparent increasing incidence of sarcomas suggests environmental causes such as pesticides. Except for some specific factors (i.e. ionizing radiation, vinyl chloride, dioxin, and genetic predispositions) the scientific knowledge on the aetiology of sarcomas is sparse and inconsistent. France is a particularly appropriate country to set up a study investigating the causes of sarcoma occurrence due to the French organization in treatment and care of sarcoma patients, which is highly structured and revolved around national expert networks. The main objective of the ETIOSARC project is to study the role of lifestyle, environmental and occupational factors in the occurrence of sarcomas among adults from a multicentric population-based case-control study. Methods and analysis: Cases will be all incident cases (older than 18 years old) identified in 15 districts of France covered by a cancer registry and/or a reference center in sarcoma’s patient care over a three-year period with an inclusion start date ranging from the 1st October 2018 to the 1st January 2020 and histologically confirmed by a second review of the diagnosis. Two controls will be individually-matched by sex, age (5-years group), and districts of residence and randomly selected from electoral list. A standardized questionnaire will be administered by a trained interviewer in order to gather information about occupational and residential history, demographic and socioeconomic characteristics and lifestyle factors. At the end of the interview, a saliva sample will be systematically proposed. This study will permit to validate or not already suspected risk factors for sarcomas such as phenoxyherbicides, chlorophenol and to generate new hypothesis to increase our understanding about the genetic and environmental contributions in the carcinogenicity process.
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Intervention: Environmental, occupational and lifestyle-related exposures
Start Date: 2019-04-25
Last Updated: 2021-08-26
Number of Patients: 6462
Recruitment Status: UNKNOWN
Condition: Sarcoma

NCTID: NCT01710605 

Title: Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers
Study Summary: The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (CTC) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of treatment will be decided by clinicians, taking into account the criteria usually used in this setting. In the CTC arm, the type of treatment will be decided by CTC count: hormone-therapy if <5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the progression-free survival: 994 patients are needed, and will be accrued in French cancer centers. Secondary clinical objectives are to compare toxicity, quality of life and overall survival between the two arms. The medico-economic study will compare cost per progression-free life years gained of the two strategies. The financial impact of centralized (one platform) vs decentralized (several platforms) CTC testing will be evaluated.
Sponsor: Institut Curie
Intervention: Circulating tumor cells counting at baseline
Start Date: 2012-02
Last Updated: 2018-04-09
Number of Patients: 800
Recruitment Status: UNKNOWN
Condition: Ductal Infiltrating Metastatic Breast Cancer

NCTID: NCT03652493 

Title: Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway
Study Summary: The investigators propose a phase II study to evaluate the efficacy of carboplatin monotherapy in the tumor subgroup of metastatic castration-resistant prostatic carcinomas with somatic abnormality in the Homologous Recombination (HR) pathway. This study may also better characterize the molecular abnormalities of tumors required for the carboplatin response
Sponsor: Centre Francois Baclesse
Intervention: Carboplatin
Start Date: 2018-09-10
Last Updated: 2021-04-30
Number of Patients: 16
Recruitment Status: TERMINATED
Condition: Castration-resistant Prostate Cancer

NCTID: NCT03410693 

Title: Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma
Study Summary: This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.
Sponsor: Bayer
Intervention: Rogaratinib (BAY1163877)
Start Date: 2018-05-31
Last Updated: 2022-09-28
Number of Patients: 175
Recruitment Status: COMPLETED
Condition: Carcinoma, Transitional Cell

NCTID: NCT00932893 

Title: An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
Study Summary: This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.
Sponsor: Pfizer
Intervention: PF-02341066
Start Date: 2009-09
Last Updated: 2017-01-02
Number of Patients: 347
Recruitment Status: COMPLETED
Condition: Carcinoma, Non-Small-Cell Lung

NCTID: NCT05617963 

Title: Durvalumab Maintenance After Thoracic Chemoradiotherapy in Frail Small Cell Lung Cancer Patients Whose Disease is Limited to the Thorax
Study Summary: This study is an academic-lead, open-label, multicenter, randomized phase II trial for frail limited disease Small Cell Lung Cancer (LD-SCLC) patients. Frail conditions are: Eastern Cooperative Oncology Group performance status (ECOG PS) 2 or ECOG PS 0-1 and older than 70 or ECOG PS 0-1 and did not receive a concomitant thoracic chemo-radiotherapy (CRT) because of comorbidities. During the screening phase, patients complete either the standard concomitant thoracic CRT and cisplatin-etoposide regimen or a sequential CRT and carboplatin. Patients showing a disease control (defined as stable disease <math display="block">SD</math>, partial response <math display="block">PR</math>, or complete response <math display="block">CR</math> according to RECIST v1.1) at the radiological evaluation performed after the end of thoracic CRT can receive prophylactic cranial irradiation (PCI) as per local practice. They will then be randomized to receive durvalumab every 4 weeks (experimental arm A) or surveillance (control arm B) as per standard of care. Thus, DURVALUNG study aims to evaluate the efficacy of durvalumab maintenance treatment in frail LD-SCLC patients who have not progressed following platinum-based concomitant or sequential CRT.
Sponsor: UNICANCER
Intervention: Durvalumab
Start Date: 2023-03-24
Last Updated: 2023-03-28
Number of Patients: 550
Recruitment Status: RECRUITING
Condition: Small Cell Lung Carcinoma

NCTID: NCT01976182 

Title: Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia
Study Summary: LGL leukemia represents a rare subtype of chronic T or NK lymphoproliferative disorders. It is an indolent disease, the main hematological or autoimmune complications lead to a treatment in more than 60% of patients. Investigators set up at the University Hospital of Rennes, a database of more than 300 patients with LGL leukemia from major French services that support this disease, and published in 2010 the largest series of patients in the world (n = 229). However, the limited heterogeneity and retrospective data collected, as all previously released, makes it difficult the proposal of consensual treatment options. If first and second line treatments are based on the use of immunosuppression with methotrexate, cyclophosphamide, or cyclosporin A, no molecule has proven superiority over others. Methotrexate and cyclophosphamide are mainly used in the first line. Invetigators just have in the literature data on about 100 patients treated with either of these drugs. Combining the results of our series with those in the literature, invetigators estimate the respective overall response rate (RG) and complete response rate (CR) in 55% and 30% for methotrexate, and 60% and 50% for cyclophosphamide. Thus, there are four objective in this study : 1. to compare the respective efficacies of methotrexate and cyclophosphamide when administered as first-line therapies in patients suffering from TK LGL leukemia with severe neutropenia or neutropenia associated with infections, and/or anemia requiring transfusions, and/or auto-immune associated disease 2. to evaluate the percentage of patients refractory to methotrexate or cyclophosphamide for which a second line treatment is efficacious 3. to explore, in case of non-response to the first-line therapy, the efficacy of ciclosporine A, the comparison being performed with the treatment which was not administered in the first-line therapy 4. to evaluate the response rate according to the phenotypic subtype of LGL leukemia.
Sponsor: Rennes University Hospital
Intervention: Methotrexate
Start Date: 2013-11-26
Last Updated: 2023-09-14
Number of Patients: 166
Recruitment Status: RECRUITING
Condition: Large Granular Lymphocytes Leukemia

NCTID: NCT02323516 

Title: Evaluation of the Efficacy of Low-dose Acetylsalicylic Acid on Diarrhea Induced by Anti-cancer Targeted Therapies.
Study Summary: The mechanisms of action of the side effects associated with targeted therapies are still poorly understood. He was found in patients treated with gefitinib, increased levels of thromboxane B2 and P-selectin Thromboxane B2 is the result of the hydrolysis of thromboxane A2, which is itself obtained from Prostaglandin H2 under the action of the thromboxane synthetase. The thromboxane A2 is produced by platelets and the active pro-thrombotic properties as follows: stimulation of platelets and activation of other increased platelet aggregation. The selectins are cell adhesion proteins with a role in the adhesion phenomena. P-selectin is expressed by platelets and endothelial cells. The demonstration of increased plasma levels of thromboxane B2 and P-selectin leaves suggest a role of platelet activation in the occurrence of side effects associated with targeted therapies. Kanazawa’s study was conducted in 39 Japanese patients, trying to assess the value of low-dose acetylsalicylic acid or 100mg per day, that is to say, anti-aggrégantes doses, the occurrence rash and diarrhea induced by gefitinib. In this study, the group of patients treated with acetylsalicylic acid presented a lower rate of side effects significantly, 58.3% versus 77.8%. The frequency of diarrhea was 18.5% (or 5 patients) in the standard group versus 0% in the group with acetylsalicylic acid. Similarly, it was found a reduction in the occurrence of skin rash, 33.3% or 4 patients in the acetylsalicylic acid group versus 74.1% s, 20 patients in the standard group. Finally, in this study, it was not revealed significant differences in terms of response to treatment with gefitinib (37% in the standard group versus 33% in the group treated with aspirin patient) It does not exist in our knowledge of prospective data evaluating the effect of acetylsalicylic acid on the reduction of side effects associated with targeted in a population of patients of Caucasian-type treatment.
Sponsor: Centre Francois Baclesse
Intervention: Acetylsalicylic acid + loperamide
Start Date: 2014-12
Last Updated: 2015-12-08
Number of Patients: 0
Recruitment Status: WITHDRAWN
Condition: Cancer

NCTID: NCT05132582 

Title: A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
Study Summary: This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.
Sponsor: Seagen Inc.
Intervention: Tucatinib
Start Date: 2022-03-07
Last Updated: 2023-11-21
Number of Patients: 650
Recruitment Status: RECRUITING
Condition: HER2 Positive Breast Cancer

NCTID: NCT03420105 

Title: Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep
Study Summary: The results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. In the long term, a better understanding will make it possible to envisage appropriate treatments to compensate for these memory difficulties and to improve the autonomy of the patients.
Sponsor: Centre Francois Baclesse
Intervention: Neuropsychological, psycho-pathological and quality of life assessments
Start Date: 2018-01-05
Last Updated: 2020-03-09
Number of Patients: 75
Recruitment Status: COMPLETED
Condition: Breast Cancer

NCTID: NCT03197805 

Title: Assessment of the Impact of RNA Genomic Profile on Treatment Decision-making in HER2 Equivocal Breast Cancer Patients
Study Summary: The American Society of Clinical Oncology (ASCO) and the /College of American Pathologists (CAP) recommend that HER2 status (negative or positive) must be determined in all patients with invasive breast cancer. The knowledge of HER2 status will help the oncologist in prescribing or not a HER2-targeted therapy to patients. Presently, two main methods are used to assess HER2 status: immunohistochemistry (IHC, protein expression) and in situ hybridization (ISH, gene expression) in order to classify tumor sample as positive, negative or equivocal. When a tumor is classified HER 2+ by IHC method, a second test is performed using ISH methods (FISH, SISH, CISH). In case of HER2 equivocal result with ISH method (4 ≤HER2 gene number copy <6), the patient is eligible to an anti-HER2 therapy after discussed during MD-MM. This decision should be individualized on the basis of patient status (comorbidities and prognosis) and patient preferences after discussing available clinical evidence. Based on molecular classification, RNA expression could help to discriminate breast cancer subtypes (luminal A, luminal B, HER2-overexpressed and triple negative). Prosigna is a genomic test, developed by NanoString® based on the PAM50 gene signature, which measures the expression of 50 genes to classify tumors into 1 of 4 intrinsic subtypes and could allow determining the HER2 status. This study was designed in order to define if such a test could help the oncologist to define the better therapeutic decision in a HER2 equivocal population. In addition, concordance tests will be performed. The aim of this study is to assess the modification decision rate between the first and the second multidisciplinary decision-making meeting in HER2 equivocal patients using genomic testing.
Sponsor: Centre Jean Perrin
Intervention: PAM 50 test
Start Date: 2017-10-16
Last Updated: 2019-07-25
Number of Patients: 26
Recruitment Status: TERMINATED
Condition: Breast Cancer

NCTID: NCT04290663 

Title: Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up
Study Summary: This trial is comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy
Sponsor: Centre Francois Baclesse
Intervention: Systematic RAI-treatment
Start Date: 2020-03-02
Last Updated: 2023-09-07
Number of Patients: 476
Recruitment Status: RECRUITING
Condition: Thyroid Cancer

NCTID: NCT02317393 

Title: Contribution of the Imaging to the Expression of intégrines αvβ3 for the Characterization of Residual Masses of Non-seminoma Tumors at the End of Chemotherapy
Study Summary: The purpose of this study is to evaluate the contribution of the imaging to the expression of intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the end of chemotherapy. The investigators hope that the results of this first stage of the clinical trial come to consolidate the preclinical results obtained by the investigators team to characterizing the interest and the strong contribution of the use of a tracer resting on the expression of αvβ3 integrine for the diagnosis of simple necrosed mass at the end of the treatment of a non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients.
Sponsor: Centre Francois Baclesse
Intervention: K5-RGD PET
Start Date: 2014-12
Last Updated: 2020-07-09
Number of Patients: 16
Recruitment Status: COMPLETED
Condition: Non-seminomatous Germ Cell Tumors

NCTID: NCT05122806 

Title: Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC
Study Summary: BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with next generation TKIs in first line, included in the national EXPLORE ALK cohort (GFPC 03-2019), a non-interventional, national, multi-center cohort of ALK-rearranged NSCLC patients. BioExALK study will be proposed to every patient included in the Explore ALK GFPC 03-2019 study. Biological analysis will be performed on tumor tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA (ctDNA). For plasma testing, after obtained patient consent, blood samples will be taken and analyzed at the Léon Bérard Center (Lyon). Biological analysis on tissue obtained at diagnosis and at disease progression will be collected and be sent for centralized analysis to the Rouen University Hospital.
Sponsor: Groupe Francais De Pneumo-Cancerologie
Intervention: RNAseq
Start Date: 2021-09-22
Last Updated: 2023-10-19
Number of Patients: 100
Recruitment Status: RECRUITING
Condition: Non-small Cell Lung Cancer

NCTID: NCT01740427 

Title: A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
Study Summary: The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.
Sponsor: Pfizer
Intervention: PD-0332991
Start Date: 2013-02-22
Last Updated: 2022-12-08
Number of Patients: 666
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: Breast Neoplasms

NCTID: NCT03275506 

Title: PEMBRO With Chemo in Neo Adj Treatment of Ovarian Cancer.
Study Summary: There are several data suggesting that pembrolizumab and bevacizumab may be synergistic. Enhanced tumor angiogenesis is commonly associated with absence of tumor-infiltrating T cells in patients. There is evidence in OC that tumor expression of VEGF is negatively correlated to the density of CD3+TILs and this phenotype is associated with early recurrence, consistent with prior studies showing a correlation of VEGF to early recurrence and short survival. Furthermore, in ascites, high levels of VEGF correlate to low numbers of NK T-like CD3+CD56+ cells This randomized phase II study aims to evaluate the efficacy of pembrolizumab in combina-tion with the standard neo adjuvant chemotherapy followed by IDS and the safety of this strategy in patients with advanced ovarian cancer. We assume that its administration in the neo adjuvant setting combination with standard of care (4 cycles of standard chemotherapy) would improve the response rate and consequently will help to achieve optimal debulking rate at IDS. After surgery, patients will continue to be treated with standard of care (chemotherapy for 2 to 5 cycles plus or less bevacizumab) or the same combination plus pembrolizumab (keytruda).
Sponsor: ARCAGY/ GINECO GROUP
Intervention: Pembrolizumab Injectable Product - Chemotherapy - Bevacizumab
Start Date: 2018-02-26
Last Updated: 2023-09-06
Number of Patients: 91
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: Ovarian Cancer Stage IV

NCTID: NCT03518606 

Title: Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours
Study Summary: This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours.
Sponsor: UNICANCER
Intervention: Durvalumab + Tremelimumab + metronomic Vinorelbine
Start Date: 2018-06-20
Last Updated: 2023-09-06
Number of Patients: 150
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: Advanced Solid Tumours

NCTID: NCT00467506 

Title: Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma
Study Summary: Phase II clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy using anti-CEAxanti-DTPA bispecific antibody and di-DTPA-131I peptide in patients with reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling time lower than 5 years)
Sponsor: Nantes University Hospital
Intervention: bispecific antibody and di-DTPA-131I
Start Date: 2004-05
Last Updated: 2011-11-11
Number of Patients: NA
Recruitment Status: COMPLETED
Condition: Thyroid Neoplasms

NCTID: NCT03651206 

Title: Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib
Study Summary: Carcinosarcomas (CS) (malignant mixed Müllerian tumors) are highly aggressive and rare tumors with a worldwide annual incidence between 0.5-3.3 cases/100.000 women. Gynecological CS, i.e. ovarian CS (OCS) and uterine CS (UCS), have a 5-year overall survival (OS) < 10% and a poor prognosis. After initial treatment (surgery +/- adjuvant radiotherapies +/- chemotherapies (CT)), vast majority of patients relapsed and received diverse CT producing modest benefits, and nearly all patients will die. After first line CT including platinum salt, monotherapy (doxorubicin or paclitaxel) is frequently used for relapsed patients, but the response rate (RR) is <20%, progression-free survival (PFS) <4 months, and OS <1 year. In this unmet need situation, a better knowledge of these aggressive neoplasms is essential to propose new therapeutic options.
Sponsor: ARCAGY/ GINECO GROUP
Intervention: Niraparib
Start Date: 2020-07-15
Last Updated: 2023-07-06
Number of Patients: 196
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: Ovarian Carcinosarcoma

NCTID: NCT03438552 

Title: Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence
Study Summary: Stereo-Re-Pro aims to provide further evidence of Stereotactic Body Radiotherapy (SBRT) as a supplementary non-invasive curative treatment for local recurrence following radiotherapy. The objective of the first part of the trial (Phase I) is to select the recommended dose for salvage SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy) based on dose-limiting toxicity observed during the 18 weeks following the initiation of salvage-SBRT. Particular attention will be paid to the quality of life and tolerance of the treatment. The objective of the second part of the trial (phase II) is to estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate.
Sponsor: UNICANCER
Intervention: Stereotactic Body Radiotherapy
Start Date: 2018-10-18
Last Updated: 2023-11-07
Number of Patients: 47
Recruitment Status: RECRUITING
Condition: Local Recurrence of Malignant Tumor of Prostate

NCTID: NCT01792726 

Title: A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer.
Study Summary: TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial in which each participating centre can use the local predefined inclusion/exclusion criteria for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are eligible to enter patients into the trial. Eligible patients are those with a higher risk of local recurrence after breast conserving surgery. After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All patients will receive whole breast EBRT. They may receive any other adjuvant treatments as deemed necessary. The protocol recommends that patients be followed at six monthly intervals for three years and then annually. The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are relapse-free survival, site of recurrence, overall survival (breast-cancer specific and non-breast cancer deaths) patient satisfaction and quality of life.
Sponsor: University College, London
Intervention: Boost to the tumour bed
Start Date: 2013-06
Last Updated: 2019-07-12
Number of Patients: 1796
Recruitment Status: UNKNOWN
Condition: Early Breast Cancer

NCTID: NCT04015804 

Title: Robotic Low Rectum Anterior Resection
Study Summary: The laparoscopic approach for total mesorectal excision (L-TME) results improved short-term outcomes. However this approach has technical limitations when the pelvis is narrow and deep. Indeed there is a limited mobility of straight laparoscopic instruments and associated loss of dexterity, unstable camera view and compromised ergonomics for the surgeon. Robotic technology was developed to reduce these limitations and offers the advantages of intuitive manipulation of laparoscopic instruments with wrist articulation, a 3-dimensional field of view, a stable camera platform with zoom magnification, dexterity enhancement and an ergonomic operating environment. A major advantage of the robotic approach is the surgeon’s simultaneous control of the camera and of the two or three additional instruments. This advantage facilitates traction and counter-traction. The technological advantages of robotic surgery should also allow a finer dissection in a narrow pelvic cavity.
Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle
Intervention: Clinical database
Start Date: 2015-03
Last Updated: 2022-11-18
Number of Patients: 833
Recruitment Status: ACTIVE_NOT_RECRUITING
Condition: Rectum Cancer

NCTID: NCT04675827 

Title: De-escalation Adjuvant Chemo in HER2+/ER-ode-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo; Dual HER2 Blockade
Study Summary: DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4 cycles) combined with subcutaneous (SC) fixed dose combination (FDC) of pertuzumab and trastuzumab (loading dose of 1200 mg pertuzumab and 600 mg trastuzumab, followed by 600 mg pertuzumab and 600 mg trastuzumab) every 3 weeks for 4 cycles. Surgery will be performed according to local guidelines in all subjects after neoadjuvant treatment. After surgery, subjects who achieve a pCR (defined as pT0/Tis pN0) will receive adjuvant pertuzumab and trastuzumab FDC SC for additional 14 cycles. Subjects with residual invasive disease will receive salvage adjuvant trastuzumab emtansine (T-DM1, 3.6 mg/kg, IV every 3 weeks) for 14 cycles. In subjects whose residual invasive disease is classified per RCB score as ≥2, 3 to 4 cycles of anthracycline-based chemotherapy may be administered, at the investigator’s discretion, before the 14 cycles of T-DM1. If histopathological analysis finds that the surgical specimen from a subject with residual disease is ER-positive and/or PR-positive, adjuvant endocrine therapy may be administered concomitantly with study treatment, at the investigator’s discretion and according to local guidelines. Adjuvant radiotherapy will be mandatory after breast-conserving surgery, whereas it will be performed according to local guidelines after mastectomy, and it will be administered concomitantly with pertuzumab and trastuzumab FDC SC in subjects who achieve a pCR, and concomitantly with T-DM1 in subjects with residual invasive disease (after anthracycline-based chemotherapy in subjects assigned to receive this treatment).
Sponsor: Jules Bordet Institute
Intervention: Pertuzumab and tratuzumab fixed dose combination
Start Date: 2022-01-17
Last Updated: 2023-09-05
Number of Patients: 1065
Recruitment Status: SUSPENDED
Condition: HER2-positive Breast Cancer

NCTID: NCT01436617 

Title: Assessing the Value of a Dosage of Anti-cetuximab in the Therapeutic Management of Patients With Colon Cancer or Upper Aero-digestive Tract and Candidates for Treatment With Cetuximab
Study Summary: The main objective of this study is to validate the utility of IgE anti-cetuximab in the treatment strategy to identify patients at risk for a severe allergic reaction to cetuximab (grade 3 or 4 of the classification of NCI) and thus reduce the incidence of severe reactions.
Sponsor: Centre Francois Baclesse
Intervention: blood sample
Start Date: 2010-01
Last Updated: 2013-03-08
Number of Patients: 303
Recruitment Status: COMPLETED
Condition: Colon Cancer

NCTID: NCT03428217 

Title: CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma
Study Summary: Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC).
Sponsor: Calithera Biosciences, Inc
Intervention: CB-839
Start Date: 2018-04-24
Last Updated: 2023-03-20
Number of Patients: 444
Recruitment Status: COMPLETED
Condition: Advanced Renal Cell Carcinoma

hasTrialTitle::Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer hasTrialTitle::Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas hasTrialTitle::SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients hasTrialTitle::Pemetrexed Plus Cisplatin for Brain Metastasis of Advanced Non - Small Cell Lung Cancer (NSCLC) hasTrialTitle::Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract hasTrialTitle::Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer hasTrialTitle::OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC hasTrialTitle::Impact of a Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients hasTrialTitle::Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology hasTrialTitle::Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients hasTrialTitle::Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD hasTrialTitle::Adjuvant Pazopanib in Stage I NSCLC hasTrialTitle::Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma hasTrialTitle::Shared Meditation Involving People With Cancer, Carers and Third Parties hasTrialTitle::National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis (ALTITUDES) hasTrialTitle::D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma hasTrialTitle::National Evaluation of the Adherence to Recommendations of Venous Thrombo Embolism Treatment in Cancer Patients hasTrialTitle::Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease hasTrialTitle::Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT) hasTrialTitle::Changes in the MRI Signal in Patients With Benign Tumors of the Brain and Meninges Treated With Proton Therapy: Impact of TEL and the Biological Dose Received hasTrialTitle::Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib hasTrialTitle::Efficacy of Parenteral Nutrition in Patients at the Palliative Phase of Cancer hasTrialTitle::Comparison of MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) in Cognitive Assessment in Geriatric Oncology hasTrialTitle::Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer hasTrialTitle::A Web-mediated Follow-up With the Web-application KidneyPRO Versus Standard Follow-up for Patients With Advanced Renal Cell Carcinoma Treated With Axitinib/Pembrolizumab in First Line hasTrialTitle::Chemotherapy and Immunotherapy as Treatment for MSS Metastatic Colorectal Cancer With High Immune Infiltrate hasTrialTitle::Study of a Treatment Driven by Early PET Response to a Treatment Not Monitored by Early PET in Patients With AA Stage 3-4 or 2B HL hasTrialTitle::Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (310 Gy) to the Historical Single-dose Radiosurgery (120 to 25 Gy) With Medico-economic Evaluation hasTrialTitle::UTOLA: UTerin OLAparib hasTrialTitle::Impact of the COVID-19 Infectious Epidemic on the Management of Oncology and Onco-hematology Patients and on the Psychological Consequences for Patients and Caregivers hasTrialTitle::Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer hasTrialTitle::Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer hasTrialTitle::Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer hasTrialTitle::Medical and Economic Evaluation for Intermediate-risk Prostate Cancer hasTrialTitle::Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers hasTrialTitle::QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program hasTrialTitle::NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy hasTrialTitle::Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation hasTrialTitle::Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment hasTrialTitle::Mesothelioma Avastin Plus Pemetrexed-cisplatin Study hasTrialTitle::Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy hasTrialTitle::Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61) hasTrialTitle::Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014) hasTrialTitle::Paclitaxel/Pazopanib for Platinum Resistant/Refractory Ovarian Cancer hasTrialTitle::AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy hasTrialTitle::An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene hasTrialTitle::A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types hasTrialTitle::Endometrial Cancer Patientes MMR Deficient Comparing Chimiotherapy vs Dostarlimab in First Line hasTrialTitle::Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer hasTrialTitle::Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL) hasTrialTitle::Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR hasTrialTitle::Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Postoperative Radiotherapy for Breast Cancer hasTrialTitle::Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH hasTrialTitle::Radiotherapy of Multiple Brain Metastases Using AGuIX® hasTrialTitle::Prevention of Alopecia in Patients With Localised Breast Cancer hasTrialTitle::Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer hasTrialTitle::Treatment Intensification With Temozolomide in Adults With a Glioblastoma hasTrialTitle::A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC hasTrialTitle::Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay hasTrialTitle::Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer hasTrialTitle::Frontline Therapy in de Novo Multiple Myeloma Patients Under 65 hasTrialTitle::Feasibility of Adapted Physical Activity Based on a Walking Platform in Hospitalized Old Patients for Cancer hasTrialTitle::Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs hasTrialTitle::First-line Gemcitabine/Cisplatin +/- Avelumab in Locally Advanced or Metastatic Bladder Carcinoma hasTrialTitle::TroVax Renal Immunotherapy Survival Trial hasTrialTitle::NIraparib and Quality Of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib hasTrialTitle::Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma hasTrialTitle::Phase II Study to Evaluate MAintenance Therapy With Olaparib or Selumetinib Plus Durvalumab According to BRCAness and KRAS Somatic Status Personalized in Metastatic Pancreatic Adenocarcinoma Patients hasTrialTitle::Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer hasTrialTitle::TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention hasTrialTitle::PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 % hasTrialTitle::Study of LY2228820 With Radiotherapy Plus Concomitant TMZ in the Treatment of Newly Diagnosed Glioblastoma hasTrialTitle::Etiosarc: Environmental Aetiology of Sarcomas From a Multicenter French Population-based Case-control Study Among Adults hasTrialTitle::Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers hasTrialTitle::Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway hasTrialTitle::Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma hasTrialTitle::An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene hasTrialTitle::Durvalumab Maintenance After Thoracic Chemoradiotherapy in Frail Small Cell Lung Cancer Patients Whose Disease is Limited to the Thorax hasTrialTitle::Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia hasTrialTitle::Evaluation of the Efficacy of Low-dose Acetylsalicylic Acid on Diarrhea Induced by Anti-cancer Targeted Therapies hasTrialTitle::A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer hasTrialTitle::Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep hasTrialTitle::Assessment of the Impact of RNA Genomic Profile on Treatment Decision-making in HER2 Equivocal Breast Cancer Patients hasTrialTitle::Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up hasTrialTitle::Contribution of the Imaging to the Expression of intégrines αvβ3 for the Characterization of Residual Masses of Non-seminoma Tumors at the End of Chemotherapy hasTrialTitle::Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC hasTrialTitle::A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) hasTrialTitle::PEMBRO With Chemo in Neo Adj Treatment of Ovarian Cancer hasTrialTitle::Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours hasTrialTitle::Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma hasTrialTitle::Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib hasTrialTitle::Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence hasTrialTitle::A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer hasTrialTitle::Robotic Low Rectum Anterior Resection hasTrialTitle::De-escalation Adjuvant Chemo in HER2+/ER-ode-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo; Dual HER2 Blockade hasTrialTitle::Assessing the Value of a Dosage of Anti-cetuximab in the Therapeutic Management of Patients With Colon Cancer or Upper Aero-digestive Tract and Candidates for Treatment With Cetuximab hasTrialTitle::CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma hasCancerType::C00-D48: All neoplasms hasCancerType::C00-C97: All cancer types hasCancerType::C00-C14: Mouth/throat cancers hasCancerType::C15-C26: Digestive system cancers hasCancerType::C30-C39: Lung/chest cancers hasCancerType::C40-C41: Bone cancers hasCancerType::C43-C44: Skin cancers/melanoma hasCancerType::C45-C49: Soft tissue cancer hasCancerType::C50: Breast cancer hasCancerType::C51-C58: Female genitalia cancers hasCancerType::C60-C63: Male genitalia cancer hasCancerType::C64-C68: Urinary system cancers hasCancerType::C69-C72: Eye and brain cancer hasCancerType::C73-C75: Thyroid and other gland cancers hasCancerType::C76-C80: Cancers of unknown or unspecified areas hasCancerType::C81-C96: Cancers of the blood and immune system hasCancerType::C97-C97: Cancers in multiple locations from the start hasCancerType::D00-D09: Early-stage cancers not yet spread hasCancerType::D10-D36: Benign tumour hasCancerType::D37-D48: Growths of uncertain nature hasCancerType::unknown isTrial

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