Trials (Institut du Cancer de Montpellier)
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NCTID: NCT00875667
Title: A Study to Determine the Efficacy of Lenalidomide Versus Investigator’s Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) Study Summary: To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma. Sponsor: Celgene Intervention: Lenalidomide Start Date: 2009-04-30 Last Updated: 2019-09-16 Number of Patients: 254 Recruitment Status: COMPLETED Condition: Mantle Cell Lymphoma
NCTID: NCT02444000
Title: gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas Study Summary: Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk of neurocognitive deterioration without impairing overall survival. Sponsor: Assistance Publique - Hôpitaux de Paris Intervention: PCV chemotherapy alone Start Date: 2015-09-22 Last Updated: 2022-10-26 Number of Patients: 280 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Anaplastic Gliomas With 1p/19q Codeletion
NCTID: NCT02302807
Title: A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] Study Summary: This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody Start Date: 2015-01-13 Last Updated: 2019-08-01 Number of Patients: 931 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT04539587
Title: Sexual Quality of Life in Women During the First Year of Adjuvant Hormonal Treatment for Breast Cancer. Study Summary: Breast cancer is the most common cancer in women worldwide. Hormonal therapy is one of the major treatments for hormone receptor positive breast tumors. It is prescribed to 70% of breast cancer patients. Hormonal therapy can be responsible for sexual dysfunction induced by hormonal changes. Extended adjuvant hormonal therapy over 5 years increases these adverse effects. According to the third “Plan Cancer” (2014-2019), sexual dysfunction prevention and screening must be systematic as an integral part of supportive care. Nevertheless, sexual quality of life remains too rarely considered. In this study, the investigator propose to evaluate sexual quality of life of women less than 51 years old during the adjuvant endocrine therapy for localized breast cancer. The investigator also intend to collect the supportive measures or interventions used by women to overcome sexual dysfunction. Finally, this study aims to evaluate the need for sexual trouble specific management and acceptability of different methods. This project is a hot topic as the interest for oncosexuality is growing, and the need for specific management is increasing with still insufficient access to specific care. Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: Quality of life Start Date: 2018-05-02 Last Updated: 2020-09-07 Number of Patients: 106 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02654587
Title: Study of OSE2101 Versus Standard Treatment as 2nd or 3rd Line in HLA-A2 Positive Patients With Advanced NSCLC After Failure of Immune Checkpoint Inhibitor Study Summary: The aim of this study is to determine if the Investigational Medicinal Product Tedopi (OSE2101) is more effective than standard treatment in treating patients with stage IIIB NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment after failure of immune checkpoint-inhibitor regimens. Sponsor: OSE Immunotherapeutics Intervention: OSE2101 Start Date: 2016-02 Last Updated: 2021-03-08 Number of Patients: 363 Recruitment Status: UNKNOWN Condition: Non Small Cell Lung Cancer
NCTID: NCT03447483
Title: Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE). Study Summary: This trial is a multicentric, prospective cohort study of 150 patients aiming to model evolution of toxicity over time in patients with solid tumor and starting first cycle of Immune Checkpoint Inhibitor (ICI) treatment. The study will be conducted on a population of patients treated with ICI in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre. The study data (immune-related adverse events) will be collected during each administration of the treatment. A questionnaire will be completed by the patient before the treatment administrations. Patients will be followed until disease progression or up to 12 months of treatment. Sponsor: Institut Claudius Regaud Intervention: Patients starting a treatment by ICI Start Date: 2018-04-20 Last Updated: 2021-01-12 Number of Patients: 150 Recruitment Status: COMPLETED Condition: Solid Tumor
NCTID: NCT04665843
Title: A Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck Study Summary: The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2021-03-02 Last Updated: 2023-10-23 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Squamous Cell Carcinoma of Head and Neck
NCTID: NCT04001543
Title: Efficacy of an Oral Immunomodulatory Nutrient on Survival During Postoperative Concomitant Chemoradiotherapy in Head and Neck Cancer Study Summary: The investigators designed a prospective randomized double-blind trial to determine if the oral immunomodulating formula could improve the disease-free survival rate in high-risk locally-advanced head and neck Squamous Cell Carcinoma patients treated with Chemoradiotherapy. Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: Immunomodulating oral supplementation Start Date: 2019-03-14 Last Updated: 2021-09-05 Number of Patients: 27 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Head and Neck Squamous Cell Carcinoma
NCTID: NCT05233787
Title: Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17) Study Summary: GRECCAR 17 will be the first prospective and randomized trial to assess a tailored policy in the use of defunctioning stoma after TME according to the personalized risk of anastomotic leakage. The tailored use of defunctioning stoma after TME for rectal cancer should improve both the quality of life of patients and the anorectal function, without any impact on anastomotic leakage. Moreover, for the healthcare system, this new approach could be a cost-effective strategy, leading to a decrease in healthcare expenses. The main objective is to compare the impact of tailored defunctioning stoma after TME for rectal cancer versus the systematic use of defunctioning stoma on the evolution of the specific Quality Of Life (QLQC30) during the 12 months after surgery. Sponsor: University Hospital, Bordeaux Intervention: Tailored use of defunctioning stoma after TME Start Date: 2022-03-24 Last Updated: 2023-08-18 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Rectal Cancer
NCTID: NCT02866747
Title: A Study Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and Durvalumab for Patients With Recurrent Glioblastoma Study Summary: This study is a phase I/II, national, multicenter, open-label study starting with a Phase I part followed by a Phase II part. The phase I part of the study aims to evaluate the safety of the association of hypofractionated stereotactic radiation therapy (hFSRT) and the anti-PD-L1 Durvalumab immunotherapy in patients with recurrent glioblastoma. A maximum number of 12 patients will be enrolled in this phase I part. Once the recommended combination schema will be declared, patients will be enrolled in the Phase II part of the study in order to evaluate the efficacy (overall survival) of the combined treatment in recurrent glioblastoma. In this Phase II part, 100 patients will be assigned by randomization to one of the two following arms: * Arm A (control arm): Radiation therapy alone * Arm B (Experimental arm): Combined treatment with Anti-PD-L1 Durvalumab Sponsor: Institut Claudius Regaud Intervention: Hypofractionated stereotactic radiation therapy Start Date: 2017-01-17 Last Updated: 2023-05-25 Number of Patients: 108 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Glioblastoma
NCTID: NCT04984837
Title: Study of Lacutamab in Peripheral T-cell Lymphoma Study Summary: This is an open-label multicenter randomized non comparative phase II study to evaluate the safety and efficacy of the monoclonal anti-KIR3DL2 antibody Lacutamab in patients with Refractory/Relapsing (R/R) KIR3DL2 positive Peripheral T Cell Lymphoma (PTCL) : Not Other Specified (NOS), PTCL-TFH (including Angioimmunoblastic T-cell Lymphoma (AITL), Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype), Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia/lymphoma (ATL), Hepatosplenic T-cell lymphoma (HSTL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T cell lymphoma (MEITL), NK-T cell lymphoma (NKT) and Aggressive NK-cell leukemia (ANKL). The design is non comparative meaning that non comparison between arms will be performed as the control arm will ensure that the assumptions used for sample size calculation are verified. For that reason, randomization is unbalanced in favor of the experimental arm (2:1). Sponsor: The Lymphoma Academic Research Organisation Intervention: Lacutamab Start Date: 2021-10-05 Last Updated: 2022-08-19 Number of Patients: 56 Recruitment Status: RECRUITING Condition: Peripheral T Cell Lymphoma
NCTID: NCT05572515
Title: A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Study Summary: The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd. Sponsor: Janssen Research & Development, LLC Intervention: Teclistamab Start Date: 2023-03-29 Last Updated: 2023-09-13 Number of Patients: 590 Recruitment Status: RECRUITING Condition: Relapsed or Refractory Multiple Myeloma
NCTID: NCT02234050
Title: Trabectedin for Recurrent Grade II/III Meningioma Study Summary: The aim of this study is to collect data on activity, toxicity and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Trabectedin Start Date: 2015-07 Last Updated: 2019-02-28 Number of Patients: 90 Recruitment Status: COMPLETED Condition: Recurrent High Grade Meningioma
NCTID: NCT04770090
Title: Research of Circulating Tumor Cells Released During Cervical Cancer Surgery Study Summary: Cervical cancer is a rare pathology. Recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during different steps of the surgery. The primary goal is to evaluate the spread of CTC during surgery on peripheral blood samples. The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively. 20 patients with early stage cervical (IA1 to IB2) eligible to coelioscopic stadification and laparoscopic surgery will be included. Sponsor: University Hospital, Montpellier Intervention: Blood samples Start Date: 2021-11-17 Last Updated: 2023-04-20 Number of Patients: 20 Recruitment Status: RECRUITING Condition: Cervical Cancer Stage IA1
NCTID: NCT03155997
Title: Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer Study Summary: The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer. Sponsor: Eli Lilly and Company Intervention: Abemaciclib Start Date: 2017-07-12 Last Updated: 2023-07-14 Number of Patients: 5637 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT03725059
Title: Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab (K) Start Date: 2018-12-27 Last Updated: 2023-09-28 Number of Patients: 1240 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT01918254
Title: A Study to Evaluate Lumretuzumab in Combination With Pertuzumab and Paclitaxel in Participants With Metastatic Breast Cancer Expressing Human Epidermal Growth Factor Receptor (HER) 3 and HER2 Protein Study Summary: This multicenter, open-label dose-escalation study with an extension phase will evaluate the safety and pharmacokinetics of lumretuzumab in combination with pertuzumab and paclitaxel in participants with metastatic breast cancer expressing HER3 and HER2 protein. Cohorts of participants will receive escalating doses of lumretuzumab intravenously (IV) every three weeks (Q3W) in combination with pertuzumab 840 milligrams (mg) IV initial dose followed by 420 mg IV Q3W and paclitaxel 80 milligrams per square meter (mg/m^2) IV weekly. After completion of dose-limiting toxicity period (21 days), the study will be conducted in two extension phase cohorts: Cohort 1 and Cohort 2. Enrollment in Extension Phase Cohort 2 will occur only upon completion of Extension Phase Cohort 1. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Sponsor: Hoffmann-La Roche Intervention: Paclitaxel Start Date: 2013-08-06 Last Updated: 2017-09-12 Number of Patients: 66 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02806154
Title: Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy Study Summary: The investigators could hypothesize that age-related changes in body composition parameters play a role in the variable tolerance to chemotherapy in the elderly. Sponsor: University Hospital, Toulouse Intervention: DEXA Start Date: 2017-03-27 Last Updated: 2023-07-19 Number of Patients: 144 Recruitment Status: COMPLETED Condition: Cancer
NCTID: NCT04822350
Title: A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA Study Summary: A multicenter ambispective (retrospective and prospective) non-interventional study of patients with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France, not impacting the treatment decision made by the treating physician and the medical management of treated patients. Sponsor: Pfizer Intervention: Avelumab Start Date: 2021-07-13 Last Updated: 2023-08-07 Number of Patients: 600 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT05056350
Title: Professional Life After Breast Cancer: Feasibility of a Coaching Program for an Adapted Return to Work Study Summary: The diagnosis of breast cancer and the treatments implemented have a significant impact on the professional situation. Maintaining employment and/or reintegration into working life are therefore major issues for cancer patients. This trial proposes to study the feasibility of a support/coaching program for a return to work in patients after breast cancer. Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: Questionnaires Start Date: 2021-09-13 Last Updated: 2023-08-23 Number of Patients: 25 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT05338775
Title: A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma Study Summary: The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor. Sponsor: Janssen Research & Development, LLC Intervention: Talquetamab Start Date: 2022-05-25 Last Updated: 2023-11-09 Number of Patients: 152 Recruitment Status: RECRUITING Condition: Relapsed/ Refractory Multiple Myeloma
NCTID: NCT02643550
Title: Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Study Summary: The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of Monalizumab given IV in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Cohorts expansion will evaluate antitumor activity of monalizumab and cetuximab with or without anti-PD(L)1 Sponsor: Innate Pharma Intervention: Monalizumab Start Date: 2015-12 Last Updated: 2023-05-12 Number of Patients: 143 Recruitment Status: COMPLETED Condition: Head and Neck Neoplasms
NCTID: NCT04459715
Title: A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX) Study Summary: The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Xevinapant (Debio 1143) Start Date: 2020-08-07 Last Updated: 2023-10-24 Number of Patients: 730 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Squamous Cell Carcinoma of the Head and Neck
NCTID: NCT06022159
Title: A Study to Evaluate Pre- or Post-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or “Fragile” (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa. Study Summary: This is a phase II, multicenter, non-randomized study. The main objective is to evaluate the treatment with hypofractionated radiation therapy in neo-adjuvant and adjuvant situations on wound healing in a population of aged patients (≥ 70 years old) or ≥ 65 years of age defined as “fragile” and treated for soft tissue sarcoma. A maximum of 70 patients will be included in this study, divided in 2 groups (35 patients per arms): a neo-adjuvant cohort and an adjuvant cohort. In the neo-adjuvant cohort, patients will receive an hypofractionated radiation therapy prior to surgery. In the adjuvant cohort, patients will undergo a surgery before receive the hypofractionated radiation therapy. Each patient will be followed for up to 3 years after the end of complete treatment (radiotherapy + surgery or surgery + radiotherapy). Sponsor: Institut Claudius Regaud Intervention: Patients will receive the hypofractionated radiation therapy (30 Gy in 5 fractions) prior to surgery. Start Date: 2023-11 Last Updated: 2023-11-08 Number of Patients: 70 Recruitment Status: RECRUITING Condition: Soft Tissue Sarcoma
NCTID: NCT04184154
Title: Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy. Study Summary: Gynecologic cancer treatments (chemoradiotherapy, brachytherapy and surgery) greatly impact patients’ sexual quality of life (QoL). Use of the vaginal dilators may reduce vaginal stenosis. Since 2011, our “Gyn and Co LR” patient education program aims to optimize early care of sexual disorders following treatment of cervical and endometrial cancer. Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: Questionnaires Start Date: 2017-04-05 Last Updated: 2021-11-04 Number of Patients: 167 Recruitment Status: COMPLETED Condition: Pelvic Cancer
NCTID: NCT04698915
Title: Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer Study Summary: GTI-4711-201 is designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the effect to OS by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic Sponsor: Galera Therapeutics, Inc. Intervention: Drug GC4711 Start Date: 2021-05-07 Last Updated: 2023-08-03 Number of Patients: 160 Recruitment Status: RECRUITING Condition: SBRT
NCTID: NCT03869190
Title: Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) Study Summary: A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with MIBC and in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status). Participants in the mUC Cohort who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen for Stage 2. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2019-06-01 Last Updated: 2023-11-13 Number of Patients: 645 Recruitment Status: RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT04732156
Title: Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System Study Summary: Multiparametric MRI of the prostate is recommended before each prostate biopsy. It identifies suspicious areas which will then be the subject of targeted biopsies. However, MRI suffers from low specificity and moderate inter-reader reproducibility, including with the use of the PI-RADS version 2.1 score. We are developing, within the framework of RHU PERFUSE, a computer-aided diagnosis system (CAD) for the detection of ISUP ≥2 cancers. This system has been trained on a database of patients who had prostate MRI and prostatectomy at the Hospices Civils de Lyon and performed well on a database of patients who had prostate MRI before biopsy at the Hopices civils de Lyon. However, one of the weaknesses of artificial intelligence systems is their low robustness when tested on MRI images from different manufacturers or institutions. The goal of the CHANGE study is to build a prospective multicenter cohort of patients who underwent prostate multiparametric MRI followed by systematic and targeted prostate biopsies. The cohort will be used for the final external validation of the CAD developed in PERFUSE. Sponsor: Hospices Civils de Lyon Intervention: Blood sample Start Date: 2021-04-14 Last Updated: 2021-12-09 Number of Patients: 420 Recruitment Status: RECRUITING Condition: Prostate Cancer
NCTID: NCT03253159
Title: Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery Study Summary: Evaluate the impact of the support in reducing postoperative adverse events in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue. Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: Hypnosis Start Date: 2014-09 Last Updated: 2020-08-10 Number of Patients: 150 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02555748
Title: Therapeutic Drug Monitoring of Sunitinib and Pazopanib in Advanced or Metastatic Renal Cell Carcinoma Study Summary: This pilot study is an open-label interventional study, prospective, non-comparative, sequential (two stages), national, multicenter study. Patients starting therapy with sunitinib or pazopanib as standard first line treatment for advanced or metastatic renal cell carcinoma will enter the study in one of the two cohorts (115 patients will be treated by sunitinib and 99 patients will be treated by pazopanib). The purpose of this study is to examine the feasibility of sunitinib and pazopanib dose individualisation based on therapeutic drug monitoring (TDM) and to assess the benefit of this approach in terms of tolerance and efficacy compared with the current empirical method based only on tolerance observation. Sponsor: Institut Claudius Regaud Intervention: Pazopanib Start Date: 2015-11-17 Last Updated: 2021-01-12 Number of Patients: 47 Recruitment Status: COMPLETED Condition: Metastatic Renal Cell Cancer
NCTID: NCT03834519
Title: Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010) Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5’-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: # Overall Survival (OS) and # Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR) As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per SOC schedule. In addition, ePRO assessments will no longer be performed and biomarker samples will no longer be collected. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-05-02 Last Updated: 2023-11-07 Number of Patients: 793 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostatic Neoplasms
NCTID: NCT04704219
Title: Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61) Study Summary: This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-02-23 Last Updated: 2023-08-29 Number of Patients: 152 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Carcinoma
NCTID: NCT04949256
Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-07-28 Last Updated: 2023-11-24 Number of Patients: 862 Recruitment Status: RECRUITING Condition: Metastatic Esophageal Squamous Cell Carcinoma
NCTID: NCT03333356
Title: Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer (GETUG-AFU 30) Study Summary: This is a randomized multicentre study in patients with high-risk MIBC to investigate adjuvant radiotherapy after radical cystectomy and pelvic lymph node dissection. The objective of the study is to provide evidence that adjuvant radiotherapy improves loco-regional control with potential benefits in survival. The study will also evaluate the quality of life of patients and the tolerance of the treatment. Sponsor: UNICANCER Intervention: pelvic radiotherapy Start Date: 2018-04-19 Last Updated: 2023-11-13 Number of Patients: 109 Recruitment Status: RECRUITING Condition: Patients With High-risk MIBC
NCTID: NCT03924856
Title: Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866) Study Summary: A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-06-13 Last Updated: 2023-11-02 Number of Patients: 907 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Bladder 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: NCT04282356
Title: Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer Study Summary: Clinicians postulate that it may be interesting to combine the two IntraPeritoneal (IP) treatments associated with a significant improvement of OC overall survival i.e. cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) and postoperative intraperitoneal chemotherapy (IPC) as an " intensive peritoneal " regimen in the initial management of stages III-IVA ovarian cancers. Performing a postoperative IPC may allow completing and extending the duration of the effect of HIPEC in decreasing the risk of peritoneal recurrence. HIPEC may also allow administering an early IP treatment on the residual microscopic disease during initial or interval surgery with an optimal access to the intraperitoneal cavity. Postoperative IPC will extend the HIPEC effect on unsterilized peritoneal microscopic residues with the aim of decreasing the risk of local recurrence. Performing HIPEC before IPC could allow limiting the number of postoperative IP courses needed. Nevertheless, this association questions its feasibility and tolerance, which should both be assessed in a phase II trial. Clinicians propose to conduct this feasibility study combining for the first time HIPEC with IPC as first-line treatment of ovarian cancer with peritoneal carcinomatosis to perform a peritoneal intensification. Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: Intraperitoneal chemotherapy during surgery Start Date: 2020-09-15 Last Updated: 2022-03-14 Number of Patients: 55 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT04282122
Title: Clinical Database of Safe Personalized Adjuvant Breast Radiotherapy Based on Individual Radiosensitivity Study Summary: Severe but also moderate toxicities after curative-intent radiotherapy (RT), such as a poor cosmetic outcome following breast cancer can have a negative impact on quality of life and a marked effect on subsequent psychological outcome. Nevertheless, current practice standards commonly prescribe radiation dose and volume without regard to individual radiosensitivity. In that context, a normal tissue radiosensitivity test that includes a rapid (72 h) radiosensitivity assay based on flow cytometric assessment of radiation-induced CD8 T-lymphocyte apoptosis (RILA) and other significant clinical parameters (multifactorial nomogram) was developed. Omission of radiotherapy has been suggested when luminal A tumor subtype is combined with clinical and pathologic factors defining a subgroup of patients with a low risk of ipsilateral breast recurrence. In this group, the benefits of radiotherapy are small <math display="block">6</math>. Reduction of the breast irradiated volume is also a possibility that has been tested and published using IORT, brachytherapy or external beam radiotherapy. Hypofractionation has been adapted to breast cancer radiotherapy. Overall, all recent clinical trials <math display="block">13, 14</math> showed only few late effects when hypofractionation was delivered to the whole breast (WB). These results reinforce the need of patients’ selection using the NovaGray Breast® test. Our hypothesis is therefore that the different techniques (volume reduction or hypofractionation) as well as radiotherapy omission will significantly reduce grade ≥2 bf+ in a personalized approach (driven by a predictive assay of late effects) compared to WB hypofractionation in a selected population at low risk of breast recurrence. We would like to establish a prospective evaluation of daily practice including the individual radiosensitivity test to the decision of daily practice Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: Radiotherapy Start Date: 2019-05-23 Last Updated: 2021-11-04 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT03762447
Title: A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors Study Summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments. Sponsor: Incyte Corporation Intervention: INCB086550 Start Date: 2018-12-10 Last Updated: 2023-11-02 Number of Patients: 138 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Solid Tumors
NCTID: NCT03253133
Title: Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC Study Summary: This study determine the maximal tolerate dose Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: Oxaliplatin Start Date: 2016-05-10 Last Updated: 2023-05-03 Number of Patients: 19 Recruitment Status: COMPLETED Condition: Colorectal Cancer
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: NCT03252912
Title: Study in Leptomeningeal Metastases of Breast Cancer Study Summary: Breast cancer (BC) is the most frequent cause of leptomeningeal metastases (LM) .As for brain parenchymal metastases, the incidence of LM seems to be increasing, due to the growing incidence of metastatic BC, the improvement of survival and the poor diffusion of therapeutic agents into the central nervous system (CNS). Several prognostic factors have been identified, including the age at diagnosis, the functional and neurological status, the delay between the diagnosis of cancer and that of LM. The survival of patients is poor, less than 6 months in most published series. Several neuronal biomarkers could also be good candidates, such as the neurogranin CSF and/or serum levels or the CNS neurofilaments (NF), that seem to be a good reflect of axonal injury and neuronal loss. CNS NF have been investigated in several neurological diseases including Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis and multiple sclerosis, but not yet in CNS metastases. Indeed, the creation of a clinico-biological collection seems to be of high value in order to investigate future biomarkers of interest Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: blood samples Start Date: 2017-01-06 Last Updated: 2020-10-19 Number of Patients: 51 Recruitment Status: COMPLETED Condition: Breast Cancer
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: NCT03248492
Title: A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) Study Summary: Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-8201a Start Date: 2017-08-25 Last Updated: 2023-11-15 Number of Patients: 253 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT00781612
Title: A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies Study Summary: This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study. Sponsor: Genentech, Inc. Intervention: Docetaxel Start Date: 2008-10-16 Last Updated: 2023-11-13 Number of Patients: 720 Recruitment Status: RECRUITING Condition: Neoplasm Metastasis
NCTID: NCT02574455
Title: Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC) Study Summary: The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician’s choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline. Sponsor: Gilead Sciences Intervention: Sacituzumab govitecan Start Date: 2017-11-07 Last Updated: 2022-06-15 Number of Patients: 529 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03643133
Title: Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients Study Summary: Trial evaluating the impact on efficacy of mifamurtide as add-on treatment to post-operative chemotherapy compared to post-operative chemotherapy alone in first-line treatment of patients with high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response). Sponsor: UNICANCER Intervention: Mifamurtide Start Date: 2018-10-23 Last Updated: 2022-12-09 Number of Patients: 126 Recruitment Status: RECRUITING Condition: Osteosarcoma
NCTID: NCT03456583
Title: Brevera™ Breast Biopsy System Data Collection Study Study Summary: The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure. This post-market clinical trial will be performed to obtain clinical/operational data and feedback on the Brevera Breast Biopsy System. Sponsor: Hologic, Inc. Intervention: Brevera Breast Biopsy System Start Date: 2017-11-20 Last Updated: 2019-02-06 Number of Patients: 500 Recruitment Status: COMPLETED Condition: Breast Cancer Female
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: NCT02260505
Title: Efficiency of Imatinib Treatment Maintenance or Interruption After 3 Years of Adjuvant Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) Study Summary: This is a 2 arms study concerning patients with primary GIST who followed an Imatinib adjuvant treatment for 3 years after surgery and who have a high risk of recurrence. In the first arm, patients will continue Imatinib treatment for 3 more years, allowing to determine if the continuation of this treatment is efficient for disease control, in terms of Disease Free Survival improvement. In the second arm, patients will discontinue the Imatinib treatment, as standard practice. This arm will allow to determine if the re-introduction of Imatinib at relapse is still an efficient treatment for the control of disease. Sponsor: Centre Leon Berard Intervention: Imatinib maintenance Start Date: 2014-12-24 Last Updated: 2023-08-30 Number of Patients: 134 Recruitment Status: RECRUITING Condition: Gastrointestinal Stromal Tumors
NCTID: NCT05109468
Title: Assessment of Patients’ Quality of Sexual Life After Anal Cancer Treatment Study Summary: The purpose of this this study, to evaluate the quality of sexual life of patients treated for anal cancer treated by radiotherapy, during their treatment, then 3 months after treatment and, finally, 2 years after treatment. cancer diagnosis. Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: Quality of life questionnaire Start Date: 2021-06-06 Last Updated: 2021-11-05 Number of Patients: 50 Recruitment Status: RECRUITING Condition: Anal Cancer
NCTID: NCT02290782
Title: TARGIT-C(Consolidation) Prospective Phase IV Study of IORT in Patients With Small Breast Cancer Study Summary: This prospective, multicentric single arm phase IV study is based on the protocol of the international TARGIT-A and TARGIT-E study. Patients ≥ 50 years with small, low-risk breast cancer who are operated but not irradiated show local relapse rates around 6% after 5 years. With adjuvant whole breast radiotherapy (WBRT) the local relapse rate drops to under 1% after 5 years under Tamoxifen (4). It has been demonstrated (6, 9, 10) that the efficacy of radiation of the tumor bed only in a selected group can be non-inferior to WBRT. The TARGIT C study should confirm the efficacy of a single dose of intraoperative radiotherapy (IORT) in a well selected group of patients with small breast cancer and absence of risk factors. In presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic treatment according to international guidelines. Endpoints are the local relapse rate (within 2 cm of the tumor bed), ipsilateral relapse, cancer-specific and overall survival and contralateral breast cancer as well as documentation of quality of life and cosmetic outcome. The expected local relapse rates are 0.825/1.375% after 3/5 years, respectively. Discontinuation of the trial is scheduled if rates of local relapse rates rise to 1.55/2.4/4% after 1/3/5 years. Power calculations result in 387 patients with a calculated dropout and loss to follow-up rate of 10%, an alpha of 0.05 and a beta of 0.10. There will be only a pre-pathology stratum. It is a pragmatic trial in which each participating centre has the option to modify entry criteria and criteria for WBRT according to this core protocol after consultation with the steering committee and local ethics committee (e.g. size, free margins). Only centers with access to the Intrabeam® system (Carl Zeiss) can recruit patients into the trial. Sponsor: Universitätsmedizin Mannheim Intervention: Intraoperative radiotherapy (IORT) Start Date: 2014-10 Last Updated: 2022-06-01 Number of Patients: 387 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT05024045
Title: Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Study Summary: The purpose of this study is to find out whether the study drug, LOXO-338, is safe and effective in patients with advanced blood cancer. Patients must have already received standard therapy. The study may last up to approximately 3 years. Sponsor: Eli Lilly and Company Intervention: LOXO-338 Start Date: 2021-09-30 Last Updated: 2023-06-01 Number of Patients: 316 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Leukemia, Lymphocytic, Chronic, B-Cell
NCTID: NCT03879109
Title: Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer Study Summary: GRECCAR 15 is focused on Locally Recurrent Rectal Cancer (LRRC) for patients with previous pelvic radiotherapy for the primary rectal cancer. This situation leads to a 20% higher risk of non-curative resection for the LRRC management (R1 status) impacting significantly the overall survival. The widespread use of neoadjuvant radiotherapy for primary rectal cancer introduces this new problem: the treatment of LRRC in previously irradiated area. The objective of GRECCAR 15 is to assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC. Sponsor: University Hospital, Bordeaux Intervention: Chemotherapy FOLFIRINOX, 6 cycles Start Date: 2019-07-08 Last Updated: 2023-01-26 Number of Patients: 58 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Rectal Cancer
NCTID: NCT04181827
Title: A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma Study Summary: The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel <math display="block">cilta-cel</math>) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd). Sponsor: Janssen Research & Development, LLC Intervention: JNJ-68284528 Start Date: 2020-06-12 Last Updated: 2023-11-09 Number of Patients: 419 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT02893527
Title: Implementation and Evaluation of a Social Journey Accompanied in Breast Cancer Diagnosis (EPARS SEIN) Study Summary: Evaluate and compare the return to work rate at 12 months Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: personalized coaching Start Date: 2015-02-24 Last Updated: 2020-08-10 Number of Patients: 11 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT03650517
Title: Minimally Invasive Right Colectomy Anastomosis Study Study Summary: Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon. A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach. However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best. MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study: # Robotic Right Colectomy with ICA # Robotic Right Colectomy with ECA # Laparoscopic Right Colectomy with ICA # Laparoscopic Right Colectomy with ECA All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery. Sponsor: Instituto de Investigación Marqués de Valdecilla Intervention: Extracorporeal Anastomosis Start Date: 2018-11-01 Last Updated: 2019-09-25 Number of Patients: 1200 Recruitment Status: UNKNOWN Condition: Colorectal Cancer
NCTID: NCT03424005
Title: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer Study Summary: This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in parallel in this study: Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line <math display="block">1L</math> PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line <math display="block">2L</math> CIT-naive cohort). Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease (HR+cohort). Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment. Sponsor: Hoffmann-La Roche Intervention: Capecitabine Start Date: 2018-04-02 Last Updated: 2023-11-07 Number of Patients: 242 Recruitment Status: RECRUITING Condition: Breast Cancer
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: NCT05601752
Title: ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3) Study Summary: This is a phase 2, open-label, randomized, non-comparative clinical trial to evaluate the clinical outcome of ADP A2M4CD8 as monotherapy and in combination treatment with nivolumab in human leukocyte antigen (HLA) A2+ subjects with recurrent ovarian cancer positive for MAGE-A4. Sponsor: Adaptimmune Intervention: Autologous genetically modified ADP-A2M4CD8 cells Start Date: 2023-06-26 Last Updated: 2023-08-28 Number of Patients: 66 Recruitment Status: RECRUITING Condition: Ovarian 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 <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: NCT03498716
Title: A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator’s choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator’s choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer) Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2018-08-02 Last Updated: 2023-09-15 Number of Patients: 2203 Recruitment Status: COMPLETED Condition: Triple Negative Breast Cancer
NCTID: NCT04526782
Title: ENCOrafenib With Binimetinib in bRAF NSCLC Study Summary: A Phase II study of the BRAF inhibitor Encorafenib in combination with the MEK inhibitor Binimetinib in Patients with BRAFV600E-mutant metastatic Non-small Cell Lung Cancer Sponsor: Intergroupe Francophone de Cancerologie Thoracique Intervention: Encorafenib 75 MG Start Date: 2021-01-19 Last Updated: 2022-10-05 Number of Patients: 119 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT03981016
Title: Medical and Surgical Management of Patients With Brain Metastases Study Summary: The integrated cancer research site (SIRIC) of Montpellier proposes to develop a prospective and regional Clinical Database Project and regional biological collection (blood and tumor samples), which is an expanding data collection designed to contribute to a better understand the patient’s management with brain metastases including quality of life and neuropsychological/cognitive aspects. Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: Biological collection Start Date: 2015-03-02 Last Updated: 2020-10-19 Number of Patients: 105 Recruitment Status: COMPLETED Condition: Central Nervous System Tumor
NCTID: NCT05486182
Title: Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer Study Summary: This is a multi-center study in France to evaluate the impact of ESTROTEP PET/CT results on the therapeutic management of patients with metastatic breast cancer (MBC). Each patient will be screened to determine whether the patient meets all the inclusion criteria and none of the exclusion criteria. After inclusion, a standardized pre ESTROTEP PET/CT questionnaire will be completed by the investigators to evaluate the initial management plan. Patient will perform the ESTROTEP PET/CT examination at visit 2. A standardized post ESTROTEP PET/CT questionnaire will then be completed by the investigators. Patients will be followed for 12 months to evaluate their clinical status and standard of care investigations. Sponsor: Zionexa Intervention: 18F Fluoroestradiol Radiopharmaceutical with PET/CT Start Date: 2022-02-08 Last Updated: 2023-02-15 Number of Patients: 152 Recruitment Status: RECRUITING Condition: Metastatic Breast 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: NCT03276468
Title: Evaluation of Atezolizumab-Venetoclax-Obinutuzumab Combination in Relapse/Refractory Lymphomas Study Summary: This study is a multicenter phase II trial which primary objective is to assess the anti-lymphoma activity of atezolizumab associated with a BCL-2 inhibitor (GDC-199, venetoclax) and an anti-CD20 monoclonal antibody (obinutuzumab) in three separate cohorts: * relapsed/refractory follicular lymphoma (FL) patients * relapsed/refractory aggressive (DLBCL) lymphoma patients * relapsed/refractory other indolent (iNHL) lymphoma patients (MZL and MALT) Sponsor: The Lymphoma Academic Research Organisation Intervention: Atezolizumab Start Date: 2018-02-12 Last Updated: 2023-01-10 Number of Patients: 136 Recruitment Status: COMPLETED Condition: Follicular Lymphoma
NCTID: NCT03197805
Title: Assessment of the Impact of RNA Genomic Profile on Treatment Decision-making in HER2 Equivocal Breast Cancer Patients Study Summary: The American Society of Clinical Oncology (ASCO) and the /College of American Pathologists (CAP) recommend that HER2 status (negative or positive) must be determined in all patients with invasive breast cancer. The knowledge of HER2 status will help the oncologist in prescribing or not a HER2-targeted therapy to patients. Presently, two main methods are used to assess HER2 status: immunohistochemistry (IHC, protein expression) and in situ hybridization (ISH, gene expression) in order to classify tumor sample as positive, negative or equivocal. When a tumor is classified HER 2+ by IHC method, a second test is performed using ISH methods (FISH, SISH, CISH). In case of HER2 equivocal result with ISH method (4 ≤HER2 gene number copy <6), the patient is eligible to an anti-HER2 therapy after discussed during MD-MM. This decision should be individualized on the basis of patient status (comorbidities and prognosis) and patient preferences after discussing available clinical evidence. Based on molecular classification, RNA expression could help to discriminate breast cancer subtypes (luminal A, luminal B, HER2-overexpressed and triple negative). Prosigna is a genomic test, developed by NanoString® based on the PAM50 gene signature, which measures the expression of 50 genes to classify tumors into 1 of 4 intrinsic subtypes and could allow determining the HER2 status. This study was designed in order to define if such a test could help the oncologist to define the better therapeutic decision in a HER2 equivocal population. In addition, concordance tests will be performed. The aim of this study is to assess the modification decision rate between the first and the second multidisciplinary decision-making meeting in HER2 equivocal patients using genomic testing. Sponsor: Centre Jean Perrin Intervention: PAM 50 test Start Date: 2017-10-16 Last Updated: 2019-07-25 Number of Patients: 26 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT00963105
Title: Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Study Summary: The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Sponsor: Celgene Intervention: lenalidomide Start Date: 2009-10-19 Last Updated: 2018-10-31 Number of Patients: 104 Recruitment Status: COMPLETED Condition: Relapsed or Refractory Chronic Lymphocytic Leukemia
NCTID: NCT02240017
Title: A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function. Study Summary: This is a phase II/III, multicenter, randomized study which includes 420 patients on six years + 3 years follow up. 92 patients will be included during the phase II ; additional 328 patients will be included. Patients with an advanced or metastatic urothelial cancer with impaired renal function will be randomized in one of the two following chemotherapy arm: * Fractionated Cisplatin + Gemcitabine. * Carboplatin + Gemcitabine. The main objective of the part II study will be to evaluate the efficacy and the safety of a chemotherapy with a doublet platinum salt compound/Gemcitabine with fractionated Cisplatin or Carboplatin in this population. The main objective of the part III study will be to compare the efficacy in terms of overall survival of a chemotherapy with a doublet platinum salt/Gemcitabine with fractionated Cisplatin or Carboplatin in this population. Sponsor: Institut Claudius Regaud Intervention: Carboplatin Start Date: 2015-01-21 Last Updated: 2019-08-09 Number of Patients: 46 Recruitment Status: COMPLETED Condition: Advanced Urothelial Cancer
NCTID: NCT03834493
Title: Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641) Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-07-28 Last Updated: 2023-06-15 Number of Patients: 1244 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostatic Neoplasms
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: NCT05315427
Title: Impact of Music Therapy on Pain in Patients Treated for Advanced Cancer Study Summary: The aim of this study is to assess the impact of music therapy on the pain of patients cared at the Montpellier Cancer Institute (ICM) for advanced cancer in a palliative situation and requiring full hospitalization or on an outpatient basis. Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: one music therapy session Start Date: 2022-05-02 Last Updated: 2023-02-16 Number of Patients: 41 Recruitment Status: COMPLETED Condition: Advanced Cancer
NCTID: NCT03651206
Title: Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib Study Summary: Carcinosarcomas (CS) (malignant mixed Müllerian tumors) are highly aggressive and rare tumors with a worldwide annual incidence between 0.5-3.3 cases/100.000 women. Gynecological CS, i.e. ovarian CS (OCS) and uterine CS (UCS), have a 5-year overall survival (OS) < 10% and a poor prognosis. After initial treatment (surgery +/- adjuvant radiotherapies +/- chemotherapies (CT)), vast majority of patients relapsed and received diverse CT producing modest benefits, and nearly all patients will die. After first line CT including platinum salt, monotherapy (doxorubicin or paclitaxel) is frequently used for relapsed patients, but the response rate (RR) is <20%, progression-free survival (PFS) <4 months, and OS <1 year. In this unmet need situation, a better knowledge of these aggressive neoplasms is essential to propose new therapeutic options. Sponsor: ARCAGY/ GINECO GROUP Intervention: Niraparib Start Date: 2020-07-15 Last Updated: 2023-07-06 Number of Patients: 196 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Carcinosarcoma
NCTID: NCT04013152
Title: Clinical Database of Colorectal Robotic Surgery Study Summary: Evaluation of robot Da Vinci Xi by determining its learning curve.The operating time will be defined by patient then the operating average will be calculated. Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: Clinical database Start Date: 2018-06-13 Last Updated: 2022-11-18 Number of Patients: 1800 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Crohn Disease
