Editing Trials (Centre François Baclesse)

'''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 &amp; 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 &lt; 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 (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.
 '''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 &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
 '''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) &lt;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 &amp; 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 &amp; 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 &amp; 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 &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
 '''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 &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
 '''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) &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
 '''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 &amp; 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