Trials (Institut Curie)
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NCTID: NCT03875573
Title: Neo-adjuvant Chemotherapy Combined With Stereotactic Body Radiotherapy to the Primary Tumour +/- Durvalumab, +/- Oleclumab in Luminal B Breast Cancer Study Summary: Neo-CheckRay is a multicenter, open-label phase II study that randomizes luminal B breast cancer subjects candidate for neo-adjuvant chemotherapy in a 1:1:1 ratio in 3 arms: 1. the combination of weekly paclitaxel followed by dose-dense doxorubicin-cyclophosphamide (ddAC) and pre-operative radiation therapy (boost dose) on the primary tumour 2. arm 1 with the addition of the anti-PD-L1 antibody durvalumab 3. arm 2 with the addition of the anti-CD73 antibody oleclumab The primary tumour will be excised 2-6 weeks after completion of ddAC. A safety run-in is planned for the 6 first subjects before starting the randomized phase II trial. Those 6 subjects will receive the treatment given in Arm 3. Sponsor: Jules Bordet Institute Intervention: Durvalumab Start Date: 2019-11-06 Last Updated: 2023-11-09 Number of Patients: 147 Recruitment Status: RECRUITING Condition: Luminal B
NCTID: NCT03017573
Title: Prospective Biobanking Study in Ovarian, Breast, Head and Neck and Cervical Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE) Study Summary: SCANDARE is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at different time points in ovarian, triple negative breast, Head and Neck Cancer and Cervical cancer patients. This study will allowed to identify new molecular and/or immunological biomarkers associated with clinical and biological features of the tumors. All patients will receive standard treatment according to the stage of the diseases and usual procédures. Sponsor: Institut Curie Intervention: Tumor biopsies / Tumor surgery Start Date: 2017-01-06 Last Updated: 2023-05-22 Number of Patients: 700 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT02839473
Title: Hydrosorb® Versus Control in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial Study Summary: The primary objective consisted of avoiding deterioration and/or restoring the integrity of the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2 radiation dermatitis. Sponsor: Institut Curie Intervention: Castalie water spray Start Date: 2010-03 Last Updated: 2016-08-11 Number of Patients: 278 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01842321
Title: Abiraterone Acetate in Molecular Apocrine Breast Cancer Study Summary: The purpose of this study is to estimate antitumour activity of abiraterone acetate in Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast Cancer. Sponsor: UNICANCER Intervention: Abiraterone Acetate Start Date: 2013-07 Last Updated: 2021-02-23 Number of Patients: 34 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02340221
Title: A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy Study Summary: This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years. Sponsor: Hoffmann-La Roche Intervention: Taselisib Start Date: 2015-04-09 Last Updated: 2022-07-12 Number of Patients: 631 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT00450892
Title: Phase I/II Study of Neoadjuvant Lapatinib in Breast Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving trastuzumab after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of docetaxel and lapatinib when given with or without combination chemotherapy and to see how well they work in treating women with locally advanced, inflammatory, or resectable breast cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: docetaxel+lapatinib Start Date: 2007-02 Last Updated: 2016-07-07 Number of Patients: 129 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01930292
Title: Debio 1143 in Combination With Carboplatin and Paclitaxel in Patient With Advanced Solid Malignancies Study Summary: This is a two-part trial in patients with squamous non-small cell lung cancer (NSCLC), platinum (Pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast cancer (TNBC). The primary objective of Part A is to determine the maximum tolerated dose (MTD) of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin. The primary objective of Part B is to consolidate the safety profile of the recommended dose of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin. Sponsor: Debiopharm International SA Intervention: Part A: Debio 1143 Start Date: 2013-04 Last Updated: 2016-03-24 Number of Patients: 31 Recruitment Status: TERMINATED Condition: Solid Tumors
NCTID: NCT02818725
Title: I-MVAC +/- Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma Without H-Ras Nor K-Ras Mutations Study Summary: OBJECTIVES OF THE TRIAL Primary objective Evaluation of efficacy in terms of progression-free survival at 9 months of the combination of intensified methotrexate, vinblastine, doxorubicin and cisplatin with or without panitumumab as first-line treatment of advanced urothelial carcinoma in patients without Harvey nor Kirsten rat sarcoma viral oncogene homolog mutations. Secondary objectives * To assess toxicity * To assess response rate * To assess overall survival * To assess time to progression * To study the correlation between response rate, time to progression, overall survival and biological parameters Sponsor: UNICANCER Intervention: Chemotherapy Start Date: 2010-06 Last Updated: 2021-03-09 Number of Patients: 133 Recruitment Status: COMPLETED Condition: Infiltrating Urothelial Carcinoma
NCTID: NCT05011721
Title: Digital Phenotyping in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy Study Summary: NeoFit is a prospective, national, multicenter, single-arm open-label study. It will include a total of 300 participants under the age of 70 years treated with neoadjuvant chemotherapy for BC. Participants will receive a Withing Steel HR activity tracker, which they will be asked to wear 24 h per day for 12 months. The principal assessments will be performed at baseline, at the end of neoadjuvant chemotherapy and at 12 months. The investigators will evaluate clinical (e.g. toxicity, efficacy of chemotherapy), lifestyle, quality of life, fatigue, and physical activity parameters. All questionnaires will be completed on a REDCap form, via a secure internet link. Sponsor: Institut Curie Intervention: Activity tracker Start Date: 2021-09-20 Last Updated: 2023-09-06 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT02364492
Title: A Phase I Study of a Therapeutic Vaccine Candidate in Patients With Localized Breast Cancer at High-Risk of Relapse Study Summary: The purpose of this study is to evaluate if a maximum tolerated dose (MTD) can be obtained following 2 administrations of the MAG-Tn3 + AS15 cancer vaccine when administered at doses of 30 µg, 100 µg or 300 µg IM every three weeks. Sponsor: Institut Pasteur Intervention: MAG-TN3 + AS15 Start Date: 2015-02 Last Updated: 2022-04-01 Number of Patients: 20 Recruitment Status: COMPLETED Condition: Breast Neoplasms
NCTID: NCT03070392
Title: Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma Study Summary: To evaluate the overall survival of HLA-A\*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab. Sponsor: Immunocore Ltd Intervention: IMCgp100 Start Date: 2017-10-16 Last Updated: 2023-03-07 Number of Patients: 378 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Uveal Melanoma
NCTID: NCT04994730
Title: Exenteration: Quality of Life Study and Rehabilitation Rate According to the Reconstruction Technique (ETRE) Study Summary: Prospective monocentric quality of life study. Including all patients who have been exentered at the Institut Curie Paris, from January 2004 to December 2019, proposing to compare the reported quality of life of patients according to the reconstruction technique they have undergone. The sponsor will evaluate the quality of life of our patients by means of two validated questionnaires, in French, in the context of ENT surgery: the FACT-G and FACT-MBIS questionnaires. Sponsor: Institut Curie Intervention: Quality of life according to the reconstruction technique Start Date: 2021-05-25 Last Updated: 2021-08-31 Number of Patients: 118 Recruitment Status: UNKNOWN Condition: Cancer
NCTID: NCT04428151
Title: Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009) Study Summary: This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review. Sponsor: Merck Sharp & Dohme LLC Intervention: Lenvatinib Start Date: 2020-08-06 Last Updated: 2023-11-24 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of Head and Neck
NCTID: NCT05444712
Title: Transplantation After Complete Response In Patients With T-cell Lymphoma Study Summary: Peripheral T-cell lymphoma (PTCL) encompasses a broad range of post-thymic (i.e., mature) sub-entities as defined by the 2017 WHO classification. The most common entities are angioimmunoblastic T-cell lymphoma (AITL) and other Tfh-phenotype PTCL or PTCL not otherwise specified (NOS), each representing approximately 20 to 25% of mature T- and NK/T-cell lymphomas. Compared to their B-cell counterparts, most PTCL confer dismal prognosis. In fact, except for anaplastic lymphoma kinase (ALK)-positive systemic anaplastic large cell lymphoma (sALCL), 10-year overall survival for patients with PTCL barely exceeds 30%. Given the infrequency and the heterogeneity of these malignancies, no real consensus on first-line treatment has been established for most PTCL. The place of autologous stem cell transplantation (ASCT) as a consolidation procedure for patients with PTCL achieving a complete metabolic response after induction is still highly debated. ESMO recommendations and recent guidelines from a committee of the American Society for Blood and Marrow Transplantation currently propose ASCT as first-line therapy for transplant-eligible patients for all patients reaching at least a partial response (PR) after induction. NCCN guidelines (version 2.2017) recommend ASCT or observation in case of metabolic CR but salvage regimen in case of residual disease after induction. Sponsor: Hospices Civils de Lyon Intervention: Chemotherapy + follow up Start Date: 2022-08-01 Last Updated: 2023-09-28 Number of Patients: 204 Recruitment Status: RECRUITING Condition: Peripheral T Cell Lymphoma
NCTID: NCT00801151
Title: Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer Study Summary: This is a multi-center, open-label non-randomized dose-escalation trial of vorinostat given in combination with vinorelbine. Cohorts will be treated with a fixed dose of vinorelbine (25mg/m²/week continuously, representing the schedule that has been approved). Patients eligible will be enrolled into a standard 3+3 design with a starting dose of vorinostat at 200 mg po qd 7/21 (weekly schedule). Then, further dose levels will be explored. Toxicity of the schedule will be assessed during the first cycle. Patients may receive up to 6 cycles of study medication. Blood samples will be collected at specified time points to assess pharmacokinetic endpoints. Sponsor: Institut Claudius Regaud Intervention: Zolinza (vorinostat), vinorelbine Start Date: 2009-01 Last Updated: 2010-05-20 Number of Patients: 30 Recruitment Status: TERMINATED Condition: Malignant Solid Tumour
NCTID: NCT05055648
Title: PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy Study Summary: The PROTECT trial will test the hypothesis that proton (PT) -enabled radiation dose reductions to sensitive, normal tissues will result in lower rates of treatment-related pulmonary complications in esophageal cancer compared to standard photon therapy (XT). Sponsor: University of Aarhus Intervention: Photon Radiotherapy Start Date: 2022-05-01 Last Updated: 2022-11-02 Number of Patients: 396 Recruitment Status: RECRUITING Condition: Esophageal Cancer
NCTID: NCT02978755
Title: First In Human Safety, Pharmacokinetics and Anti-tumoral Activity of GM102 in Gynecological Cancers Study Summary: First in Human study, assessing the safety profile, the pharmacokinetics and preliminary antitumor activity of GM102, a new compound (a monoclonal antibody), in patients with previously treated gynecological cancers bearing the AMHRII (anti-mullerian Hormone Receptor II) receptor. The primary objective of the study is to determine the GM102 recommended dose. Sponsor: GamaMabs Pharma Intervention: GM102 Start Date: 2016-06 Last Updated: 2022-04-06 Number of Patients: 78 Recruitment Status: COMPLETED Condition: Neoplasm, Gynecologic
NCTID: NCT01390948
Title: A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma Study Summary: This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety, tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy with concomitant and adjuvant TMZ as compared to postoperative radiotherapy with concomitant and adjuvant TMZ alone in paediatric participants with newly diagnosed histologically confirmed World Health Organization (WHO) Grade III or IV localized supratentorial or infratentorial cerebellar or peduncular high grade glioma (HGG). Participants will be randomly assigned to one of two treatment arms. Upon approval by the Health Authorities/Ethics Committees in the participating countries, an additional young participant cohort (YPC) (children \>/= 6 months and \< 3 years of age with progressive or relapsed metastatic or localized, supra- or infratentorial, non-brain stem WHO Grade III or IV HGG) was included in the study. Children in the YPC will receive bevacizumab and TMZ without radiation therapy. The anticipated time on study treatment is over 1 year. Sponsor: Hoffmann-La Roche Intervention: Bevacizumab Start Date: 2011-10-18 Last Updated: 2020-08-06 Number of Patients: 124 Recruitment Status: COMPLETED Condition: High Grade Glioma
NCTID: NCT03893955
Title: A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors Study Summary: A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or chemotherapy in participants with selected solid tumors. This study consists of 2 main parts, a dose-escalation phase and a dose-expansion phase. The dose-expansion phase can begin once the recommended phase 2 dose/maximum tolerated dose (RP2D/MTD) is determined in the dose-escalation phase. Sponsor: AbbVie Intervention: ABBV-927 Start Date: 2019-05-21 Last Updated: 2023-02-06 Number of Patients: 150 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cancer
NCTID: NCT05625412
Title: A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors Study Summary: The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or nivolumab in participants with advanced solid tumors. Sponsor: Bristol-Myers Squibb Intervention: BMS-986360 Start Date: 2022-12-09 Last Updated: 2023-11-02 Number of Patients: 220 Recruitment Status: RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT04447755
Title: A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080) Study Summary: The main purpose of this study is to evaluate the antitumor activity and safety of Lenvatinib (MK-7902/E7080) in children, adolescents, and young adults with relapsed or refractory solid malignancies after administration. Participants will be enrolled into initial tumor-specific cohorts which will be expanded based on observed response. Sponsor: Merck Sharp & Dohme LLC Intervention: Lenvatinib Start Date: 2020-07-30 Last Updated: 2023-10-04 Number of Patients: 127 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Relapsed or Refractory Solid Tumors
NCTID: NCT03870919
Title: Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients Study Summary: Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic. De novo metastatic breast cancer accounts for 20% to 25% of these cases. Despite a decrease in mortality in Europe and North America due to early detection and access to treatment, breast cancer remains the 2ⁿᵈ leading cause of cancer deaths in developed countries after lung cancer and the world's leading cause. In the ESME French national retrospective cohort (NCT03275311), the newly diagnosed estrogen receptor (ER)-positive and HER2-negative (luminal) metastatic patients had a 59.1 months overall survival (OS) for pre-menopausal women and 44.7 months for postmenopausal women. In the same cohort, the median OS was 47.4 months for de novo metastatic patients with hormone receptor (HR)-positive / HER2-negative breast cancer. The most important current treatment for metastatic breast cancer remains systemic therapy. Surgery and radiation are mainly used to treat symptoms. However, more than 15 retrospective studies have assessed the impact of locoregional treatment on relapse and OS. These studies suggested an improvement of the OS in patients with de novo metastatic breast cancer thanks to the addition of locoregional treatment to systemic therapy. Recent data from the ESME cohort suggest that patients with de novo luminal or HER2-positive metastatic breast cancer may benefit from local treatment of the primary tumor. Several prospective trials have attempted to demonstrate the benefit of locoregional treatment with mixed results. This can be explained by a limited power of statistical analysis, on the recruitment of patients with breast cancer of all types, and on a limited access to effective systemic therapies in some cases and all before the area of anti CD4/6 which is the current standard treatment in patients with HR-positive / HER2-negative luminal metastatic disease. However, guidelines indicate that a "multimodal approach, including curative locoregional treatments, should be considered". As a result, many clinicians offer locoregional treatment of the primary tumor, especially if there is a good response to the first line of systematic treatment. Taken together, these data underscore the need for an evaluation of the value of combined therapy - endocrine therapy - CDK4/6 inhibitor and locoregional treatment - in this population of patients with newly diagnosed HR-positive / HER2-negative breast cancer. Sponsor: UNICANCER Intervention: Palbociclib Start Date: 2019-10-23 Last Updated: 2023-05-31 Number of Patients: 200 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer Stage IV
NCTID: NCT04424719
Title: Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME) Study Summary: Biomarkers search for early diagnosis of liver metastases in patients with uveal melanoma who benefit from a follow-up tailored to their personalized risk of relapse. Sponsor: Institut Curie Intervention: Blood test Start Date: 2020-07-08 Last Updated: 2023-01-20 Number of Patients: 700 Recruitment Status: RECRUITING Condition: Uveal Melanoma
NCTID: NCT03644186
Title: To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH) Study Summary: This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade. Sponsor: ETOP IBCSG Partners Foundation Intervention: Paclitaxel Start Date: 2019-04-16 Last Updated: 2023-07-25 Number of Patients: 144 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT04238819
Title: A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma Study Summary: The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did not respond or grew during other anti-cancer treatment. For each participant, the study is estimated to last up to 2 years. Sponsor: Eli Lilly and Company Intervention: Abemaciclib Start Date: 2020-11-09 Last Updated: 2023-10-11 Number of Patients: 117 Recruitment Status: RECRUITING Condition: Relapsed Solid Tumor
NCTID: NCT03869619
Title: REal World Data in LYmphoma and Survival in Adults Study Summary: REALYSA cohort is a population-based epidemiological platform in real-life for lymphomas designed to enrich prognostic data, by integrating together epidemiological, clinical and biological data. REALYSA is a platform perfectly set up to * Study prognostic factors using integrated epidemiological and biological data (genetics), to better characterize the determinants of refractoriness and relapse in patients with lymphoma, to follow the growing number of survivors and describe median to long-term sequela, second cancer, quality of life (QoL)... * Document treatment effectiveness in real life and observance * Address socio-economical questions Sponsor: Hospices Civils de Lyon Intervention: Real-life epidemiological platform of lymphoma in France Start Date: 2018-11-14 Last Updated: 2021-06-28 Number of Patients: 6000 Recruitment Status: RECRUITING Condition: Diffuse Large B Lymphoma (DLBCL)
NCTID: NCT05475366
Title: Personalized First-line Chemotherapy Choice in Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures Study Summary: The aim of this study is to assess the clinical value of 5 transcriptomic signatures prognostic of chemotherapeutic sensitivity to improve the Objective Response Rate (ORR) of first-line (L1). Chemotherapy regimen (FOLFIRINOX vs Gem-nabP) will be selected based on transcriptomic signatures applied to the pre-therapeutic liver biopsy of newly diagnosed PDAC patients. Sponsor: Institut Curie Intervention: Clinical value of 5 transcriptomic signatures to personalize the therapeutic decision for L1 in PDAC Start Date: 2022-12-12 Last Updated: 2023-05-18 Number of Patients: 62 Recruitment Status: RECRUITING Condition: Carcinoma, Pancreatic Ductal
NCTID: NCT00706030
Title: Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer Study Summary: The purpose of this study is to identify the highest tolerable dose of neratinib (HKI-272) in combination with vinorelbine and to assess the safety of the combination of the two drugs as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors. The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with advanced solid tumors. In the second part of the study, approximately 60 additional subjects with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib, are planned to be added to better define the tolerability and preliminary activity of HKI-272 in combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory analyses. Sponsor: Puma Biotechnology, Inc. Intervention: neratinib Start Date: 2008-04-29 Last Updated: 2018-08-09 Number of Patients: 92 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02244125
Title: A Multicenter Open Label Phase II Study of Pomalidomide and Cyclophosphamide and Dexamethasone in Relapse/Refractory Multiple Myeloma Patients Who Were First Treated Within the IFM/DFCI 2009 Trial Study Summary: Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide (Revlimid) and bortezomib (Velcade), and have demonstrated disease progression on the last therapy. Patients with relapsed and refractory multiple myeloma who have received bortezomib, lenalidomide, dexamethasone combination, considered to be the multiple myeloma optimal treatment, can access to pomalidomide under marketing authorization only as from third line of treatment. In France this combination is not authorized for marketing for a first line treatment and only patient randomized in the IFM/DFCI 2009 trial received it. This study concerns patients previously randomized in the IFM/DFCI 2009 trial who have received bortezomib, lenalidomide and Dexamethasone combination in first line, which at progression/relapse time therapeutic opportunities remained limited and who cannot access pomalidomide under marketing authorization. This study is a multicentre, phase 2, open label, study testing the triple combination of pomalidomide and cyclophosphamide and dexamethasone (PCD) in multiple myeloma patients who are refractory or in first progression/relapse after a first line treatment with bortezomib and lenalidomide, an IMiDs (an Immuno Modulatory Drug and a proteasome inhibitor) according to the IFM/DFCI 2009 trial. In the IFM/DFCI trial, patients in arm A received eight cycles of the Velcade-Revlimid-Dexamethasone combination followed by 1 year of lenalidomide maintenance, patients in arm B received 3 cycles of Velcade-Revlimid-Dexamethasone combination plus melphalan 200mg/m2 with an autologous transplantation followed by 2 cycles of Velcade-Revlimid-Dexamethasone combination consolidation and 1 year of lenalidomide maintenance. This study will contain 3 treatment phases: * Study treatment phase: All patients will receive 4 cycles (28 days) of pomalidomide-cyclophosphamide-dexamethasone combination. * Consolidation phase (depends on the initial randomization in the IFM/DFCI 2009 trial): * For patients previously randomized in IFM/DFCI 2009's arm A: * Melphalan 200 mg/m2 followed by Autologous Transplantation * Three months after, 2 cycles of pomalidomide-cyclophosphamide-dexamethasone combination * For patients previously randomized in IFM/DFCI 2009's arm B: * 5 cycles of pomalidomide-cyclophosphamide-dexamethasone combination * Maintenance phase (identical to all patients) subsequent cycles of pomalidomide and Dexamethasone until progression / relapse or discontinuation for any other reason. For arm B patients, in case relapse occurs at least 12 months after the end of the maintenance IFM/DFCI 2009 trial, they could proceed to a second autologous transplantation and therefore follow the arm A procedure. The decision to proceed to a second transplant will be made by the physician and the patient. In order to have the same amount of patients enrolled in this trial in the initial Arm A and Arm B of the IFM/DFCI 2009 trial, once 50 patients have been included in either arm A or B, subsequent patients will be eligible if they have not been initially treated as the first 50 patients from either arm. The primary endpoint is the response rate (Partial Response (PR) or better) after 4 cycles of the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD) in the studied population using International Myeloma Working Group (IMWG) response criteria. Sponsor: Institut Curie Intervention: PCD Start Date: 2014-04-14 Last Updated: 2023-07-05 Number of Patients: 100 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT04827030
Title: ER-One: A Double-blind Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery Study Summary: The block (ESP or PVB) will be performed preoperatively in the recovery room under standard monitoring. After setting a peripheral venous access, patient will be installed on lateral decubitus position on the opposite side of the block. Sponsor: Institut Curie Intervention: Ropivacaïne Hydrochloride by Erector Spinae block Start Date: 2021-06-28 Last Updated: 2021-11-17 Number of Patients: 292 Recruitment Status: UNKNOWN Condition: Breast Surgery
NCTID: NCT03498521
Title: A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site Study Summary: This study will compare the efficacy and safety of molecularly-guided therapy versus standard platinum-containing chemotherapy in participants with poor-prognosis cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum based induction chemotherapy. Sponsor: Hoffmann-La Roche Intervention: Alectinib Start Date: 2018-07-10 Last Updated: 2023-11-18 Number of Patients: 790 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cancer of Unknown Primary Site
NCTID: NCT05581121
Title: PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer Study Summary: This is an international, multicenter and randomized open-label phase III study designed to demonstrate, in patients with stage IIIC1 cervical cancer, whether para-aortic lymphadenectomy followed by tailored chemoradiation is associated with increased disease-free survival compared to patients staged with FDG-PET/CT only followed by chemoradiation. The planned sample size is 510; including 200 patients in France. In this trial, patients will be assigned in one of the two following treatments arms: Arm A (control arm): Standard chemo-radiotherapy and brachytherapy according to EMBRACE II and ESGO/ESTRO recommendations. Arm B (experimental arm): Pretherapeutic para-aortic lymphadenectomy followed by tailored chemo-radiotherapy and brachytherapy. Each patient will be followed up for 5 years. Sponsor: Institut Claudius Regaud Intervention: Standard treatment: Control arm Start Date: 2023-12 Last Updated: 2023-10-30 Number of Patients: 510 Recruitment Status: NOT_YET_RECRUITING Condition: Cervical Carcinoma
NCTID: NCT01349842
Title: Circulating Tumor Cells to Guide Chemotherapy for Metastatic Breast Cancer Study Summary: Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer. Sponsor: Institut Curie Intervention: Blood sampling Start Date: 2010-03-02 Last Updated: 2019-03-21 Number of Patients: 265 Recruitment Status: COMPLETED Condition: Breast Cancer Ductal Infiltrating Metastatic
NCTID: NCT03878342
Title: Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast Study Summary: Following breast-conserving surgery (BCS) for localized ductal carcinoma in situ (DCIS) of the breast, whole-breast irradiation (WBRT) is a standard of care, reducing the absolute rate of in-breast recurrences (IBR) by more than 15% at 10 years, from 28% without radiotherapy to 13 % with radiotherapy. Half of the recurrences occurred as invasive disease. Whereas in the comparative trials, WBRT did not impact on overall survival, survival of patients who recurred with invasive cancers was impaired in comparison to patients who did not recur, or to patients with DCIS-only recurrences. Using criteria based on age, tumor size, nuclear grade, and margins status, several trials and cohort studies failed to identify subgroups of patients at low risk, who could be safely spared the need for WBRT. The Radiation Therapy Oncology Group (RTOG) DCIS trial included patients treated with BCS for low- or intermediate grade DCIS revealed by unifocal microcalcifications, size ≤25 mm, margins ≥3 mm, and no residual microcalcifications after surgery. The 5-year rates of IBR were 3.5 % without radiotherapy, versus 0.4 % with radiotherapy, and 6.7 % and 0.9 % at 7 years, respectively (p \<0.001). Sixty percent of the patients received tamoxifen in both groups. Several studies showed that the same molecular classes were identified in DCIS as in invasive cancers. Studies suggested that low proliferation, hormone receptors expression, and lack of ERBB2 amplification were associated with a low risk of IBR in patients not receiving radiotherapy. A combined signature was tested in the Eastern Cooperative Oncology Group (ECOG) trial, showing a 10% IBR rate at ten years in patients with a low-risk. Identifying very low-risk DCIS, using biological markers in addition to the clinical and histological markers of low-risk DCIS, could help to select patients who could be safely avoided WBRT following BCS. It would avoid over-treatment in these women and could decrease the cost of management. Sponsor: UNICANCER Intervention: Radiotherapy Start Date: 2019-05-10 Last Updated: 2022-08-02 Number of Patients: 300 Recruitment Status: RECRUITING Condition: DCIS
NCTID: NCT02554565
Title: Innovation for Standard Identification of Insertional HPV Mutations and of Target Therapeutic Genes in Cervical Cancer: Towards Development of Personalized Biomarkers in Clinical Oncology Study Summary: Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease. Sponsor: Institut Curie Intervention: Tumor biopsy Start Date: 2014-07-29 Last Updated: 2019-03-20 Number of Patients: 26 Recruitment Status: TERMINATED Condition: Cervical Cancer
NCTID: NCT03353831
Title: Atezolizumab With Bevacizumab and Chemotherapy vs Bevacizumab and Chemotherapy in Early Relapse Ovarian Cancer Study Summary: This is a phase III, randomized, partially blinded, multicenter trial to evaluate the efficacy and safety of atezolizumab plus bevacizumab and chemotherapy compared to placebo plus bevacizumab and chemotherapy in patients with recurrent ovarian-, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after platinum based chemotherapy or 3rd relapse. Sponsor: AGO Research GmbH Intervention: Bevacizumab Start Date: 2018-09-11 Last Updated: 2022-07-27 Number of Patients: 550 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Recurrent Ovarian Carcinoma
NCTID: NCT01026142
Title: A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA) Study Summary: This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity. Sponsor: Hoffmann-La Roche Intervention: Capecitabine Start Date: 2010-01-26 Last Updated: 2018-08-14 Number of Patients: 452 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT04109131
Title: A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours Study Summary: Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental. Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome. In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies. Sponsor: Jules Bordet Institute Intervention: Samples collection: Plasma Start Date: 2020-07-01 Last Updated: 2023-03-28 Number of Patients: 600 Recruitment Status: RECRUITING Condition: CNS Metastases
NCTID: NCT05354765
Title: Exploration of Adaptive Antitumoral Immune Cells Through Lymphapheresis in Cancer Patients : ALCYTA Study Summary: The study will evaluate the detection of tumor-antigen specific immune cells in cancer patients in whom the role of the immune system is suspected. Sponsor: Institut Curie Intervention: blood sample Start Date: 2022-08-28 Last Updated: 2023-05-01 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT01166542
Title: Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers Study Summary: The purpose of this Phase 3 study is to evaluate overall survival and progression free survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck. Sponsor: Oncolytics Biotech Intervention: REOLYSIN Start Date: 2010-06 Last Updated: 2014-11-05 Number of Patients: 167 Recruitment Status: COMPLETED Condition: Carcinoma, Squamous Cell of the Head and Neck
NCTID: NCT05041842
Title: Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer Study Summary: The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment. Despite these advances, the development of brain metastases remains a serious and devastating complication that decreases quality of life and increases morbidity and mortality. The HER2CLIMB randomized study demonstrated that adding the investigational drug tucatinib to the standard treatment trastuzumab and capecitabine improved both progression-free survival and overall survival in people diagnosed with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer, previously treated with trastuzumab, pertuzumab, and T-DM1. In patients with brain metastases, the 1-year progression-free survival was 25% in the tucatinib group and 0% in the placebo group. These results suggest that tucatinib may be a new standard treatment for HER2-positive metastatic disease. The aim of the non-randomized phase II study, InTTercePT, is to evaluate the effectiveness of adding tucatinib to trastuzumab and pertuzumab in the event of cerebral progression, after the end of local treatment. Sponsor: UNICANCER Intervention: Tucatinib Start Date: 2021-12-17 Last Updated: 2023-09-22 Number of Patients: 55 Recruitment Status: RECRUITING Condition: Metastatic Breast Cancer With a Isolated Brain Progression
NCTID: NCT02338531
Title: Biomarker Research Study for PF-03084014 in cHEmoresistant Triple-negative Breast cAncer Study Summary: This is a phase II open label Biomarker Research Study off PF-03084014 in non-metastatic triple-negative breast cancer patients with residual disease (cHEmoresistant) after completion of standard neoadjuvant chemotherapy. Sponsor: Jules Bordet Institute Intervention: PF-03084014 Start Date: 2015-06 Last Updated: 2016-04-29 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Breast Cancer
NCTID: NCT05293925
Title: Consultation to Announce the End of Chemotherapy and Specific Treatments in an Outpatient Setting: Evaluation of the Psychological Impact and Information Exchange. Study Summary: The average 5-year survival rate for patients diagnosed with cancer in France is estimated at 53%. Nearly half of all patients diagnosed with cancer are not alive 5 years after diagnosis Discontinuation of anti-tumor treatments is therefore a major issue in their care. Discussing the discontinuation of specific treatments requires scientific oncological skills but also communication skills. The difficulties encountered by oncologists concerning communication about the end of life are linked to the doctors' personal discomfort with death, their fear of the responsibility of stopping chemotherapy, and their distrust of their colleagues. On the other hand, they may also come from patients who are supposedly reluctant to talk about the end of life, a reluctance that is heightened in the case of language barriers, young age or pressure from families. Finally, the place of practice could explain some of the difficulties in talking about the end of life, notably because of a lack of training in delivering bad news or a stigma attached to palliative care. This exploratory work should make it possible to describe the characteristics of the announcement of the cessation of anti-tumor treatments in ambulatory patients, to evaluate distress, anxiety, depressive symptomatology, as well as the satisfaction of the patients concerning the management received. Sponsor: Institut Curie Intervention: announcement of cessation of treatment Start Date: 2022-01-27 Last Updated: 2022-04-05 Number of Patients: 40 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT01469455
Title: DNA Repair Inhibitor & Irradiation on Melanoma Study Summary: Phase I trial will be conducted in patients suffering local metastatic melanoma with relapsed cutaneous/subcutaneous tumors including melanoma-in-transit. Based on the preclinical data package, DNA Therapeutics has considered that the risk-benefit ratio of DT01 supports the initiation of a phase I clinical study in this population. The recommended starting dose of DT01 for the first injection to human was based on NOAELs and Maximum Recommended Starting Dose (MRSD) calculations and by considering both local and systemic approaches. It was set at 16 mg (4 mg per injection site, 2 injections per tumor, 2 tumors to be treated). This starting dose will be increased up to 96 mg if no DLT occurred during dose escalation. DT01 will be locally administered by peritumoral subcutaneous and/or intratumoral injections in combination with hypo-fractionated radiotherapy (RT) (10x 3 Gy) and chloroquine (100 mg oral QD) starting one week before DT01 and RT treatments. DT01 will be administered 3 times a week during two weeks; The study will be an open, non-randomised, multicentre, phase I dose escalation (16, 32, 48, 64 and 96 mg) safety study with a 3+3 design. The purpose of this study will be to evaluate the safety, tolerance, pharmacokinetics of DT01 in association with palliative radiotherapy and to evaluate pharmacodynamics and the anti-tumor activity of DT01 according to RECIST criteria on day 26, 40 and 54. The duration of response (Time-To-Local Recurrence, TTLR), will be monitored 3, 6, 9 and 12 months after the beginning of the DT01 treatment. Sponsor: DNA Therapeutics Intervention: DT01 Start Date: 2011-10 Last Updated: 2016-06-17 Number of Patients: 27 Recruitment Status: COMPLETED Condition: Local Metastatic Melanoma
NCTID: NCT04145817
Title: Breast Cancer Risk After Diagnostic Gene Sequencing
Study Summary: Study of the psychological impact of breast cancer risk communication in Cancer Genetics based on the personalized estimation of the BOADICEA V5/PLUS model ("Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm-version 5 or PLUS").
Sponsor: Institut Curie
Intervention: BRIDGES gene panel testing
Start Date: 2019-10-22
Last Updated: 2023-01-20
Number of Patients: 405
Recruitment Status: COMPLETED
Condition: Genetic Predisposition to Disease
NCTID: NCT05794906
Title: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies Study Summary: Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen \[PSMA\] positron emission tomography \[PET\]) /computed tomography \[CT\]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a "tracer" that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: * take blood and urine samples. * measure PSA and testosterone levels in the blood samples * do physical examinations * check the participants' overall health * examine heart health using electrocardiogram (ECG) * check vital signs * check cancer status using PSMA PET/CT scans, CT, MRI and bone scans * take tumor samples (if required) * ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants' health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first. Sponsor: Bayer Intervention: Darolutamide (BAY1841788, Nubeqa) Start Date: 2023-04-03 Last Updated: 2023-10-30 Number of Patients: 750 Recruitment Status: RECRUITING Condition: Biochemically Recurrent Prostate Cancer
NCTID: NCT03013504
Title: A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients Study Summary: In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in terms of efficacy, safety and pharmacokinetics. Sponsor: Prestige Biopharma Limited Intervention: HD201 Start Date: 2018-02-19 Last Updated: 2023-02-08 Number of Patients: 503 Recruitment Status: COMPLETED Condition: HER2 Positive Breast Cancer
NCTID: NCT02049905
Title: Phase 3 Study to Treat Patients With Soft Tissue Sarcomas Study Summary: The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas. Sponsor: ImmunityBio, Inc. Intervention: Aldoxorubicin Start Date: 2014-01 Last Updated: 2022-03-29 Number of Patients: 433 Recruitment Status: COMPLETED Condition: Metastatic, Locally Advanced or Unresectable Soft Tissue Sarcoma
NCTID: NCT02866149
Title: Analysis of Circulating Tumor Markers in the Blood (ALCINA) Study Summary: Exploratory study on blood-borne biological markers and their correlation with clinical and pathological characteristics. Sponsor: Institut Curie Intervention: Blood sampling Start Date: 2015-07 Last Updated: 2023-09-06 Number of Patients: 682 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cancer
NCTID: NCT02132949
Title: A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer Study Summary: This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel. Participants in both cohorts will subsequently undergo surgical treatment and then resume pertuzumab and trastuzumab treatment. Sponsor: Hoffmann-La Roche Intervention: 5-Fluorouracil Start Date: 2014-07-14 Last Updated: 2021-09-17 Number of Patients: 401 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT05284305
Title: Desmoid Tumor and Pregnancy: Effect of Pregnancy on Disease Control and Effect of Diagnosis on Pregnancy History. Study Summary: Desmoid tumors (DT) are rare disease of intermediate malignancy with variable and often unpredictable clinical course. There is a growing interest in defining potential risk of recurrence or progression during or after pregnancy and in identifying potential obstetrical risks and infertility rate of desmoid patients. Aim of the study: * to define the impact of pregnancy on diagnosis, progression and recurrence of DT; * to define the risks related to DT of obstetrical risks and decisions to interrupt or avoid pregnancy after the diagnosis of DT. Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: Pregnancy Start Date: 2022-03-01 Last Updated: 2023-01-27 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Desmoid
NCTID: NCT01710605
Title: Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers Study Summary: The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (CTC) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of treatment will be decided by clinicians, taking into account the criteria usually used in this setting. In the CTC arm, the type of treatment will be decided by CTC count: hormone-therapy if \<5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the progression-free survival: 994 patients are needed, and will be accrued in French cancer centers. Secondary clinical objectives are to compare toxicity, quality of life and overall survival between the two arms. The medico-economic study will compare cost per progression-free life years gained of the two strategies. The financial impact of centralized (one platform) vs decentralized (several platforms) CTC testing will be evaluated. Sponsor: Institut Curie Intervention: Circulating tumor cells counting at baseline Start Date: 2012-02 Last Updated: 2018-04-09 Number of Patients: 800 Recruitment Status: UNKNOWN Condition: Ductal Infiltrating Metastatic Breast Cancer
NCTID: NCT01956552
Title: Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting (ESOPE) Study Summary: The primary objective is to compare the phenotype and genotype of the primary tumor with those of its metastases in order to optimize the treatment of metastatic disease, in patients presenting with first metastatic progression of breast cancer. Sponsor: Institut Curie Intervention: biopsy or cytopuncture Start Date: 2009-11 Last Updated: 2016-07-12 Number of Patients: 130 Recruitment Status: TERMINATED Condition: Metastatic Breast Cancer
NCTID: NCT04656652
Title: Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-1062a Start Date: 2020-12-21 Last Updated: 2023-11-18 Number of Patients: 590 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT05307705
Title: A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors Study Summary: The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse. Sponsor: Eli Lilly and Company Intervention: LOXO-783 Start Date: 2022-05-11 Last Updated: 2023-11-02 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT04469205
Title: Study to Assess the Impact of Personalized Coaching on the Time Period and Quality of Return to Work After Breast Cancer Study Summary: Evaluate the impact of coaching sessions on the return to work rate (number of patients returning at work / total number of patients per arm) 6 months after inclusion in the study for breast cancer in professionnally active patients. Sponsor: Institut Curie Intervention: Coaching sessions Start Date: 2020-10-05 Last Updated: 2022-06-30 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT03298893
Title: Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months Study Summary: To date, the majority of clinical trials on checkpoint inhibitors have tested these agents as monotherapy, and the next logical step is to evaluate rational therapeutic associations. The aim of the NiCOL study is to assess the safety of nivolumab in association with chemoradiation therapy and to gain initial insight into its efficacy in association with the current standard of care, including chemoradiation. Sponsor: Institut Curie Intervention: Nivolumab Injection Start Date: 2017-11-27 Last Updated: 2022-04-29 Number of Patients: 21 Recruitment Status: COMPLETED Condition: Cervical Cancer
NCTID: NCT02408393
Title: MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery Study Summary: Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence of chronic pain 3 months after breast cancer surgery. Sponsor: Institut Curie Intervention: Saline Start Date: 2015-03-27 Last Updated: 2019-07-10 Number of Patients: 380 Recruitment Status: COMPLETED Condition: Malignant Neoplasm of Breast
NCTID: NCT02393820
Title: Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma Study Summary: Open-label, multicenter, single arm phase II study, set up in collaboration with the "Réseau d'Expertise Français sur les Cancers ORL Rares" (REFCOR), evaluating the activity and safety of single agent pazopanib in recurrent or metastatic tumors in salivary gland including adenoid cystic carcinoma (ACC) and to exploring the activity and safety of pazopanib in non-adenoid cystic carcinoma (non-ACC). Sponsor: UNICANCER Intervention: pazopanib Start Date: 2013-08-26 Last Updated: 2019-10-29 Number of Patients: 72 Recruitment Status: COMPLETED Condition: Salivary Gland Carcinoma
NCTID: NCT01455363
Title: Post-occlusive Reactive Hyperemia and Basal-cell Carcinoma Study Summary: The investigators aim to test the hypothesis and to proof thank to laser speckle contrast imaging that post-occlusive reactive hyperemia (PORH) can be induced through a tumor, in this case, through a basal cell carcinoma, which will be used as a model of study of tumor vasculature. This new concept of tumor perfusion artificial increase could be used in the future for malignant tumors treatment, in order to increase tumor mean oxygen partial pressure (thus decreasing tumor hypoxia, hallmark of malignant tumors) during cancerology therapies, like radiotherapy and/or chemotherapy, and increase their efficacy. This clinical trial will use skin flap model for trunk and facial basal cell carcinoma (BCC), with respect the classical excision margin of BCC surgery (3-4mm): after local anesthesia, a little random pattern skin flap will be raised around the BCC, then the cutaneous pedicle will be clamped with surgical clamp for 3 minutes and clamp released. In case of limb BCC, limb tourniquet will be used, and occluded during 3 minutes upstream to the BCC location. During all steps of experimentation, laser speckle imaging will be used to measure continuously the peri-tumoral and tumoral perfusion, start from tumor excision, up to10 minutes after tumor pedicle clamp or tourniquet release. Sponsor: Institut Curie Intervention: BCC surgery Start Date: 2011-06 Last Updated: 2012-04-04 Number of Patients: 12 Recruitment Status: COMPLETED Condition: Carcinoma, Basal Cell
NCTID: NCT04145349
Title: CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor Study Summary: This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory desmoplastic small round cell tumor (DSRCT) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond. Sponsor: Eli Lilly and Company Intervention: Ramucirumab Start Date: 2020-01-22 Last Updated: 2023-10-19 Number of Patients: 34 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Desmoplastic Small Round Cell Tumor
NCTID: NCT02875652
Title: Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU) Study Summary: Quantification and follow-up during 3 years of circulating tumoral DNA in patients with choroidal melanoma Sponsor: Institut Curie Intervention: Blood sampling Start Date: 2013-03-21 Last Updated: 2020-08-07 Number of Patients: 800 Recruitment Status: COMPLETED Condition: Choroidal Melanoma
NCTID: NCT03838263
Title: Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer Study Summary: The aim of this research is to study the feasibility of neoadjuvant treatment before chemoradiation in "high risk" HPV-driven Oropharynx cancer Sponsor: UNICANCER Intervention: Nivolumab Start Date: 2019-07-25 Last Updated: 2023-05-11 Number of Patients: 62 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Oropharynx Cancer
NCTID: NCT02243605
Title: Cabozantinib S-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma Study Summary: This phase II trial studies how well cabozantinib s-malate works in treating patients with osteosarcoma or Ewing sarcoma that has grown or returned (come back) after a period of improvement. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may also prevent the growth of new blood vessels that tumors need to grow. Sponsor: National Cancer Institute (NCI) Intervention: Cabozantinib S-malate Start Date: 2014-12-19 Last Updated: 2023-10-31 Number of Patients: 90 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Ewing Sarcoma
NCTID: NCT05441163
Title: ProActIF-01 Trial: Randomized Study of Evaluation of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Lung or Digestive Cancers Study Summary: The ProActIF-01 trial aims to assess the efficacy of a supervised 8-week combined APA and nutrition individualized program on survival without HRQoL deterioration (European Organization for Research and Treatment of Cancer-Quality of Life-C30 questionnaire, EORTC QLQ-C30, 1 targeted dimension), in advanced lung or digestive cancer patients. Sponsor: Institut Curie Intervention: APA and nutrition intervention Start Date: 2023-04-08 Last Updated: 2023-04-24 Number of Patients: 273 Recruitment Status: RECRUITING Condition: CANCER
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 \[SD\], partial response \[PR\], or complete response \[CR\] 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
