Trials (Institut Paoli-Calmettes)

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NCTID: NCT04070443

Title: Safety and Efficacy of Ponatinib Followed by Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase 
Study Summary: The investigators hypothesize that, in newly diagnosed de novo chronic phase CML patients, an induction treatment with ponatinib for 6 months should increase the rate of patients reaching a stable MR4.5 allowing cessation of imatinib treatment.  The investigators proposal is to conduct a multicenter, Phase II trial to evaluate the safety, clinical and biological activity of an induction treatment with ponatinib for 6 months, followed by a consolidation treatment with imatinib in newly diagnosed de novo chronic phase CML patients. 
Sponsor: Centre Leon Berard 
Intervention: Ponatinib 
Start Date: 2019-11-13 
Last Updated: 2022-12-16 
Number of Patients: 170 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Philadelphia Chromosome Positive CML 

NCTID: NCT00112697

Title: Radiation Therapy and Docetaxel With Either Fluorouracil or Cisplatin as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery 
Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer.  PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery. 
Sponsor: UNICANCER 
Intervention: cisplatin 
Start Date: 2003-10-06 
Last Updated: 2021-02-17 
Number of Patients: 71 
Recruitment Status: COMPLETED 
Condition: Pancreatic Cancer 

NCTID: NCT05096390

Title: Axitinib +/- Pembrolizumab in First Line Treatment of mPRCC 
Study Summary: Multicenter Phase II Study of Axitinib +/- Pembrolizumab in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC) 
Sponsor: Centre Leon Berard 
Intervention: Axitinib Oral Tablet [Inlyta] 
Start Date: 2022-01-25 
Last Updated: 2022-08-29 
Number of Patients: 72 
Recruitment Status: RECRUITING 
Condition: Papillary Renal Cell Carcinoma Type 2 

NCTID: NCT05169567

Title: Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer 
Study Summary: This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond. 
Sponsor: Eli Lilly and Company 
Intervention: Abemaciclib 
Start Date: 2022-03-11 
Last Updated: 2023-10-23 
Number of Patients: 350 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Neoplasm 

NCTID: NCT03943667

Title: Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma 
Study Summary: This study aims to evaluate whether the combination of gemcitabine and paclitaxel allows to improve the overall survival compared to gemcitabine alone, in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC) after FOLFIRINOX failure or intolerance. 
Sponsor: UNICANCER 
Intervention: Gemcitabine 
Start Date: 2019-05-23 
Last Updated: 2023-11-08 
Number of Patients: 211 
Recruitment Status: COMPLETED 
Condition: Metastatic Pancreatic Adenocarcinoma 

NCTID: NCT04712097

Title: A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma 
Study Summary: This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior systemic therapy. 
Sponsor: Hoffmann-La Roche 
Intervention: Mosunetuzumab 
Start Date: 2021-10-27 
Last Updated: 2023-11-03 
Number of Patients: 474 
Recruitment Status: RECRUITING 
Condition: Relapsed or Refractory Follicular Lymphoma 

NCTID: NCT02117167

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

NCTID: 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: NCT03679767

Title: A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203) 
Study Summary: The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established. 
Sponsor: Incyte Corporation 
Intervention: Retifanlimab 
Start Date: 2019-01-09 
Last Updated: 2023-07-21 
Number of Patients: 121 
Recruitment Status: COMPLETED 
Condition: Metastatic Non-small Cell Lung Cancer 

NCTID: NCT00740467

Title: Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disorders 
Study Summary: RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, together with antithymocyte globulin before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. Giving chemotherapy before or after transplant also stops the patient’s immune system from rejecting the donor’s stem cells. The donated stem cells may replace the patient’s immune cells and help destroy any remaining cancer and abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body’s normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.  PURPOSE: This phase II trial is studying how well stem cell transplant works in treating patients with hematological cancer or other disorders. 
Sponsor: Institut Paoli-Calmettes 
Intervention: anti-thymocyte globulin 
Start Date: 2008-01 
Last Updated: 2010-01-28 
Number of Patients: 50 
Recruitment Status: UNKNOWN 
Condition: Graft Versus Host Disease 

NCTID: NCT00636467

Title: Axillary Sentinel Lymph Node Detection in Breast Cancers; 2 cm
Study Summary: The purpose of this study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection).  Eligible patients will only be registered (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 25 months (24 months for patient inclusion + 1 month for reception of results). The maximum participation duration of each patient is 1 month.  The number of patients required in this multicentric and prospective study is 240 (16 participating centers). 
Sponsor: Centre Leon Berard 
Intervention: No name 
Start Date: 2008-03 
Last Updated: 2012-09-26 
Number of Patients: 249 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT00674414

Title: Trastuzumab With or Without Everolimus in Treating Women With Breast Cancer That Can Be Removed By Surgery
Study Summary: RATIONALE: 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. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving everolimus together with trastuzumab is more effective than giving trastuzumab alone in treating women with breast cancer.  PURPOSE: This randomized phase II trial is studying trastuzumab and everolimus to see how well they work compared to trastuzumab alone before surgery in treating patients with breast cancer that can be removed by surgery. 
Sponsor: UNICANCER 
Intervention: trastuzumab 
Start Date: 2008-04 
Last Updated: 2013-01-18 
Number of Patients: 82 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT03784014

Title: Molecular Profiling of Advanced Soft-tissue Sarcomas 
Study Summary: MULTISARC is a randomized multicenter study assessing whether high throughput molecular analysis (next generation sequencing exome - NGS) is feasible in advanced/metastatic soft-tissue sarcoma patients, that is, whether NGS can be conducted for a large proportion of patients, with results available within reasonnable delays.  In parallel, MULTISARC aims to assess efficacy of an innovative treatment strategy guided by high throughput molecular analysis (next generation sequencing exome, RNASeq <math display="block">NGS</math>) in patients with Advanced/metastatic soft-tissue sarcomas. At the end of first-line treatment, participant’s tumor profile of experimental Arm NGS (treatment strategy based on NGS results) will be discussed within a multidisciplinary tumor board which aims at discussing the genomic profiles and at providing a therapeutic decision for each participant. Participants for whom a targetable genomic alteration has been identified will be proposed to enter in one of the subsequent phase II single-arm sub-trial. 
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France 
Intervention: Nilotinib 
Start Date: 2019-10-19 
Last Updated: 2022-10-05 
Number of Patients: 960 
Recruitment Status: RECRUITING 
Condition: Soft Tissue Sarcoma 

NCTID: NCT04713514

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

NCTID: NCT03805022

Title: Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas 
Study Summary: The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up). 
Sponsor: Institut Bergonié 
Intervention: Doxorubicin 
Start Date: 2019-02-14 
Last Updated: 2023-03-01 
Number of Patients: 351 
Recruitment Status: RECRUITING 
Condition: Non-metastatic Soft-tissue Sarcoma 

NCTID: NCT02861287

Title: Economic Evaluation of the Use of Plerixafor for Autologous HSC Transplantation for Multiple Myeloma 
Study Summary: This study aims to realize an economic evaluation of the introduction of Plerixafor in addition to G-CSF and alternative options, in patients with multiple myeloma (MM) who failed or insufficiently mobilize peripheral blood stem and progenitor cells in response to G-CSF alone. 
Sponsor: Institut Paoli-Calmettes 
Intervention: Economic evaluation 
Start Date: 2015-01 
Last Updated: 2016-08-10 
Number of Patients: 60 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT05404685

Title: Partial Nephrectomy in Low Pressure 
Study Summary: The main objective is to prospectively assess the impact of low insufflation pressure using AirSeal system (7mm Hg) during RAPN on post-operative patient pain (main location and intensity), 24 hours after surgery. The study will be conducted among 15 centers of the French research network on kidney cancer UroCCR. 
Sponsor: University Hospital, Bordeaux 
Intervention: Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy 
Start Date: 2022-10-04 
Last Updated: 2023-10-16 
Number of Patients: 280 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Kidney Tumors Treated With Minimally Invasive Surgery 

NCTID: NCT02921685

Title: Study of a Humanized Antibody Initiated 2 Months After an HLA Matched Allogenic Stem Cell Transplantation 
Study Summary: This study will determine the Maximal Tolerated Dose if any and the recommended dose for phase 2 of monalizumab, a monoclonal antibody directed against the CD94 KG2A receptor, after allogenic stem cell transplantation. All patients will receive one single intravenous administration of one of the four doses of monalizumab. 
Sponsor: Institut Paoli-Calmettes 
Intervention: Monalizumab 
Start Date: 2016-11-28 
Last Updated: 2018-09-19 
Number of Patients: 18 
Recruitment Status: UNKNOWN 
Condition: Hematologic Malignancies 

NCTID: NCT02806687

Title: Effect of Intratumoral Injection of Gene Therapy for Locally Advanced Pancreatic Cancer 
Study Summary: Pancreatic ductal adenocarcinoma (PDAC) is the fifth leading cause of cancer-related death in Western countries, and its incidence has increased over the last 40 years. Curative surgery to manage PDAC is possible in only a fraction of patients; indeed, a vast majority (85%) of patients is diagnosed with locally advanced tumors and/or metastases because they lack specific symptoms and early markers for this disease. For these patients, palliative armamentarium consists of conventional chemotherapeutic agents such as Gemcitabine and, more recently, FOLFIRINOX, which offer marginal survival benefits. Consequently, the prognosis for PDAC is still very poor and there is great need for new treatments that can change this poor outcome. In this context, the investigators have devised, in the past few years, a highly innovative approach based on therapeutic gene transfer, which does not rely on a specific genetic and/or cellular background to inhibit PDAC tumor growth. the investigators found that SSTR2 and DCK::UMK gene transfer demonstrated complementary therapeutic effects to inhibit tumor progression and dissemination, and reduced tumor burden, respectively. On the basis of these promising preclinical data, the investigators conducted past three years the first clinical study of non-viral vector-mediated therapeutic gene delivery, guided by endoscopy (EUS), and combined with standard Gemcitabine therapy in patients with locally advanced and metastatic PDAC. The phase 1 demonstrated that the gene-therapy product CYL-02 is expressed in PDAC tumors (with long-lasting expression within tumor tissues), is distributed within the bloodstream in some extent, when combined with Gemcitabine it can inhibit primary-tumor progression and dissemination. Our results tend to demonstrate therapeutic efficacy, especially in patients with locally advanced tumors. Based on these encouraging results, the investigators propose that patients with locally advanced PDAC at the time of diagnosis may clinically benefit from this approach.  This phase II study is designed to compare the efficacy of intra-tumoral gene delivery of CYL-02 plus Gemcitabine treatment or Gemcitabine alone in patient with locally advanced PDAC. 
Sponsor: University Hospital, Toulouse 
Intervention: Gene Therapy product CYL-02 
Start Date: 2017-01-30 
Last Updated: 2023-03-30 
Number of Patients: 68 
Recruitment Status: COMPLETED 
Condition: Pancreatic Adenocarcinoma 

NCTID: NCT00283985

Title: Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer (NK)-T-cell Lymphoma
Study Summary: Nasal type NK-T-cell lymphoma is a rare and severe type of non-Hodgkin’s lymphoma (NHL) more frequent in Asia than in western countries. When localised, radiotherapy seems to be the best treatment. When radiotherapy cannot be used because of dissemination or relapse, chemotherapy protocols used for other types of NHL give poor results and survival is poor. Recently papers from China and Japan reported the efficacy of a drug: l-asparaginase, usually used to treat acute lymphoblastic leukemia. In vitro a selective apoptosis of NK-cell tumours by l-asparaginase was shown on tumour cell lines and samples.  The investigators propose a phase II protocol for patients with refractory or relapsing nasal type NK-T-cell lymphoma using a regimen combining l-asparaginase, methotrexate and dexamethasone. Biological studies will be conducted trying to find factors which could predict responses to this chemotherapy.  Since january 2009, the study concerns all patients with nasal type NK-T-cell lymphoma who have not received asparaginase before. 
Sponsor: University Hospital, Limoges 
Intervention: Kidrolase 
Start Date: 2006-02 
Last Updated: 2013-02-28 
Number of Patients: 40 
Recruitment Status: COMPLETED 
Condition: Lymphoma, Non-Hodgkin 

NCTID: NCT00866047

Title: A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma 
Study Summary: This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL. 
Sponsor: Seagen Inc. 
Intervention: brentuximab vedotin 
Start Date: 2009-03 
Last Updated: 2017-03-22 
Number of Patients: 58 
Recruitment Status: COMPLETED 
Condition: Lymphoma, Large-Cell, Anaplastic 

NCTID: NCT04655885

Title: Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery 
Study Summary: Major hepatectomies are high-risk surgeries offered more and more frequently for the curative treatment of primary or secondary liver cancer, and for complex cases, representing a real challenge for medical teams. The 1st peroperative phase of “hepatic resection” requires a minimum supply of filling fluids to limit perioperative bleeding (Low Central Venous Pressure). However this strategy exposes the risk of organ hypoperfusion due to low cardiac flow, secondary to hypovolaemia, which may lead to ischemic situations favoring the onset of postoperative complications. On the other hand, the hemodynamic management of the 2nd peroperative phase “post hepatic resection” is marked by the need to correct this hypoperfusion by optimizing cardiac output by suitable vascular filling.  The major challenge is thus to restore cardiac output by refilling without excess, by correcting the hypovolemia that arose during the “post resection of the hepatic parenchyma” phase.  Our hypothesis is that an individualized protocol for optimizing intraoperative cardiac flow by guided vascular filling during the “post hepatic resection” phase is accompanied by a reduction in postoperative complications in patients operated on for major hepatic surgery. 
Sponsor: Institut Paoli-Calmettes 
Intervention: Optimization of cardiac flow by base water-electrolyte supply 
Start Date: 2022-02-03 
Last Updated: 2022-03-23 
Number of Patients: 186 
Recruitment Status: RECRUITING 
Condition: Primary or Metastatic Hepatic Adenocarcinoma 

NCTID: NCT02584985

Title: Evaluate Efficacy, Morbidity and Functional Outcome of Endoscopic TranAnal Proctectomy vs Standard Transabdominal Laparoscopic Proctectomy for Rectal Cancer 
Study Summary: Standard surgical treatment of mid and low rectal cancer is total mesorectal excision (TME). Originally performed by open surgery, TME demonstrated improved local control and reduced urogenital morbidity. Laparoscopic approach has been validated by several randomised controlled trials: laparoscopic approach offers to the patient a better post-operative recovery, a lower risk of wound hernia and comparable oncological results. However, the risk of conversion to open procedure remains significant.  Endoscopic Transanal Proctectomy allows retrograd mesorectal excision, performing the whole pelvic dissection via a specific-moderate cost device. The procedure is then completed by a briefer transabdominal laparoscopic step to mobilise the colon and perform inferior mesenteric vessels ligation, prior to low coloanal anastomosis. The originality of this approach is to perform a surgical dissection via an extra peritoneal route, without peritoneal and abdominal wound trauma. This focuses on new technical improvement in the area of mini-invasive pelviabdominal surgery using natural orifice as surgical access. This approach offer closer and better exposure of pelvic dissection plane and could improve oncological quality and pelvic nerve preservation. It could be profitable to postoperative patient outcome. However rates and type of cancer-recurrences as well as functional results have to be assessed in a controlled study. This technique has shown to be feasible and reproducible through early clinical series. Conversion rates appear to be lower than published rates of laparoscopic approach, markedly inferior to 10%. Compiled rates of morbidity (27.8%), R1 resection* (6%), mesorectum macroscopic integrity (100%) appear to be comparable to laparoscopic approach results. However functional results as well as urologic morbidity have to be evaluated in comparative studies. In a preliminary retrospective comparative (n=72) we founded comparable oncological quality criteria (R1 resection 5.9% vs 10.5% p 0.74, Grade 3 mesorectal integrity 57.5 vs 56.2 p 0.99), lower conversion rate to open procedure (2.9% vs 23.6% p 0.011), shorter in-hospital stay (8 vs 9 days p 0.038). Comparable morbidity rates (Dindo 1-4 27% vs 34% p 0.52) and functional results (Kirwan 1/2 80.3% vs 80.6% p 0.94) were also founded. These data need to be confirmed. To this date, Endoscopic Transanal Proctectomy has been evaluated through preliminary studies including several short series demonstrating the feasibility of the technique and showing low morbidity. For some authors the benefit of transanal approach is significant in difficult cases such as male patient and narrow pelvis. Very recently, two non randomised comparative studies were published with conclusions close to those in our study.  Investigators propose, with the support of the GRECCAR group, to conduct a national, multicenter, open-label randomized study based on oncological non-inferiority (R1 resection rate) for the main objective, comparing Endoscopic Transanal Proctectomy to Standard Transabdominal Laparoscopic Proctectomy, for low lying rectal cancer requiring manual colo-anal anastomosis. There is a clear expected benefit expected for the patients through the ETAP procedure in term of post operative short term outcome, risk of conversion to open procedure, risk of wound hernia.This trial could also show significant advantages in terms of quality of dissection, quality of the specimen, quality of nerve preservation. 
Sponsor: Institut Paoli-Calmettes 
Intervention: ETAP 
Start Date: 2016-01 
Last Updated: 2019-01-23 
Number of Patients: 226 
Recruitment Status: RECRUITING 
Condition: Rectal Cancer 

NCTID: NCT01528085

Title: Evaluation of Efficacy and Safety of Nilotinib in Combination With Chemotherapy in Elderly Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia 
Study Summary: The goal of this trial is to evaluate the efficacy and the tolerance of the combination of nilotinib with chemotherapy in the front-line setting as induction and consolidation therapy in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be used in this trial with the addition of nilotinib as concomitant therapy during induction, consolidation and maintenance. The patients will be prospectively monitored for minimal residual disease and bcr-abl tyrosine kinase domain mutations. 
Sponsor: Goethe University 
Intervention: Nilotinib 
Start Date: 2012-01 
Last Updated: 2020-07-30 
Number of Patients: 79 
Recruitment Status: COMPLETED 
Condition: Philadelphia Chromsome Positive Acute Lymphoblastic Leukemia 

NCTID: NCT04115007

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

NCTID: NCT02545283

Title: A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) 
Study Summary: This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare overall survival in participants with relapsed or refractory AML treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine. Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle 1). Responding participants may continue to receive a maximum of further two cycles of consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet count recovery (CRp), overall remission rate (ORR), event-free survival (EFS) and percentage of participants with an allogeneic hematopoietic stem cell transplant (HSCT) will also be compared between treatment arms. This study will include participants with and without TP53 wild type (TP53 WT) mutations. 
Sponsor: Hoffmann-La Roche 
Intervention: Cytarabine 
Start Date: 2015-12-30 
Last Updated: 2022-01-11 
Number of Patients: 447 
Recruitment Status: TERMINATED 
Condition: Leukemia, Myeloid, Acute 

NCTID: NCT02859883

Title: Evaluation of Oesogastroduodenoscopy With Vision to 245 ° (Full Spectrum Endoscopy) to View the Main Disc and Accessory 
Study Summary: The monitoring and prognosis of patients with familial polyposis adenomatous rests on analysis of the transitional mucosa at the anal margin and especially on the tracking, characterization and resection of lesions of dysplasia type of high grade at the duodenal level, after total proctocolectomy. Currently, endoscopes with axial or lateral vision are used. The FUSE technology allows the simplification or even the improvement of patient surveillance with a 245° vision (versus150° in case of classical gastroscope). The use of a second screen to enlarge the field of view may allow both analysis of duodenum and the main and accessory papilla with one single endoscope and to decrease the number of omitted lesions . 
Sponsor: Institut Paoli-Calmettes 
Intervention: gastroscope FUSE™ 
Start Date: 2015-03-18 
Last Updated: 2017-10-26 
Number of Patients: 73 
Recruitment Status: COMPLETED 
Condition: Adenoma of the Accessory Papilla 

NCTID: NCT02869607

Title: Institut Paoli Calmettes Breast Cancer Database 
Study Summary: Database of Institut Paoli-Calmettes patients diagnosed with breast cancer 
Sponsor: Institut Paoli-Calmettes 
Intervention: Data collection 
Start Date: 1995-01 
Last Updated: 2016-08-17 
Number of Patients: 45000 
Recruitment Status: RECRUITING 
Condition: Breast Cancer Diagnosis 

NCTID: NCT03470883

Title: Predictive Factors for Failure or Success of Endoscopic Treatment of Superficial Colorectal Tumors 
Study Summary: To evaluate the long-term complete remission rate (> 12 months) after endoscopic treatment of early neoplastic colorectal lesions. 
Sponsor: Institut Paoli-Calmettes 
Intervention: Evaluation of the long-term complete remission rate (> 12 months) 
Start Date: 2012-01-01 
Last Updated: 2018-05-24 
Number of Patients: 100 
Recruitment Status: COMPLETED 
Condition: Superficial Colorectal Tumors 

NCTID: NCT04817007

Title: A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis) 
Study Summary: The purpose of this study is to assess the safety, tolerability, and efficacy of BMS-986158 alone and in combination with either Ruxolitinib or Fedratinib in participants with Dynamic International Prognostic Scoring System (DIPSS)-intermediate or high risk blood cancer. Part 1 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and Part 2 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and BMS-986158 alone. 
Sponsor: Bristol-Myers Squibb 
Intervention: BMS-986158 
Start Date: 2021-03-23 
Last Updated: 2023-11-18 
Number of Patients: 216 
Recruitment Status: RECRUITING 
Condition: Myelofibrosis 

NCTID: NCT03339843

Title: Multiorgan Metabolic Imaging Response Assessment of Abemaciclib 
Study Summary: Open-label, phase II, basket trial. This trial is a screening program for abemaciclib efficacy in multiple platinum-resistant tumour types by using metabolic imaging (PERCIST) and RECIST v1.1 criteria.  Based on the rate of FDG-avidity and the absence of deactivation of the Rb gene function in more than 95% of cases, we propose to define 5 tumour types of interest in a preliminary stage:  # Platinum-refractory esophageal adenocarcinoma (ADC) # Platinum-refractory esophageal squamous cell carcinoma (SCC) # Platinum-refractory cholangiocarcinoma # Platinum-refractory and progressive after immunotherapy urothelial cancer # Platinum-refractory endometrial cancer 
Sponsor: Jules Bordet Institute 
Intervention: Abemaciclib 
Start Date: 2018-12-19 
Last Updated: 2023-07-10 
Number of Patients: 85 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Esophageal Adenocarcinoma 

NCTID: NCT01900743

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

NCTID: NCT00003683

Title: Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.  PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and ifosfamide in treating patients who have metastatic kidney cancer. 
Sponsor: UNICANCER 
Intervention: doxorubicin hydrochloride 
Start Date: 1998-03 
Last Updated: 2021-02-21 
Number of Patients: 40 
Recruitment Status: COMPLETED 
Condition: Kidney Cancer 

NCTID: NCT04733183

Title: Efficacy and Safety of L19TNF in Previously Treated Patients With Advanced Stage or Metastatic Soft-tissue Sarcoma
Study Summary: Open label, randomized, controlled phase II study preceded by a safety run-in part in subjects with advanced or metastatic soft-tissue sarcoma. 
Sponsor: Philogen S.p.A. 
Intervention: Dacarbazine 
Start Date: 2020-08-28 
Last Updated: 2023-10-10 
Number of Patients: 98 
Recruitment Status: RECRUITING 
Condition: Soft Tissue Sarcoma 

NCTID: NCT03336333

Title: A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL 
Study Summary: To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review. 
Sponsor: BeiGene 
Intervention: Zanubrutinib 
Start Date: 2017-10-31 
Last Updated: 2023-11-09 
Number of Patients: 590 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Chronic Lymphocytic Leukemia 

NCTID: NCT02867033

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

NCTID: NCT02568683

Title: Safety and Efficacy of Entospletinib (ENTO [GS-9973]) Combined With Vincristine (VCR) in Adult Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL) 
Study Summary: The primary objective of this study is to evaluate the safety of ENTO with VCR in participants with relapsed or refractory B-cell NHL. 
Sponsor: Gilead Sciences 
Intervention: Entospletinib 
Start Date: 2016-02-11 
Last Updated: 2019-04-17 
Number of Patients: 10 
Recruitment Status: TERMINATED 
Condition: Non-Hodgkin Lymphoma 

NCTID: NCT01247233

Title: Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI) for Breast Cancer 
Study Summary: The standard treatment for localized breast cancer is based on conservative surgery (when possible) followed by radiation therapy (RT) delivered to the whole breast. The recommended total RT dose is 45 to 50 Gy delivered in 4.5 to 5 weeks followed by a 10 to 16 Gy boost to the tumor bed for 1 to 1.5 weeks. The rationale for the development of APBI was based on the difficulty for many patients to reach RT centers to receive standard whole breast irradiation (WBI) after conservative surgery. APBI offers decreased overall treatment time and several theoretical advantages over WBI, including a decrease in dose delivered to uninvolved portions of the breast and adjacent organs. If equivalence between the two treatments can be shown, then APBI will be considered as a historic evolution in breast cancer management.  In this phase III trial, designed in postmenopausal women >50 years of age, the objective is to compare the effectiveness and safety of APBI compared with whole breast irradiation. This study is also designed to ensure high quality criteria for surgery, pathology and RT techniques in the 3 arms and will allow to provide data on economics and costs. 
Sponsor: UNICANCER 
Intervention: Whole Breast Irradiation + Boost or Hypofractionated irradiation 
Start Date: 2010-12-27 
Last Updated: 2023-03-01 
Number of Patients: 1006 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT00590837

Title: Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old 
Study Summary: A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5 + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in complete remission (CR) will then receive a post-remission schedule with or without lomustine according to randomization. Patients from 60 to 65 years old will be proposed to reduced conditioning allogeneic transplantation after first consolidation. 
Sponsor: University Hospital, Bordeaux 
Intervention: Lomustine 
Start Date: 2008-02 
Last Updated: 2014-04-02 
Number of Patients: 459 
Recruitment Status: COMPLETED 
Condition: Acute Myeloid Leukemia 

NCTID: NCT02541383

Title: A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma 
Study Summary: The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma. 
Sponsor: Intergroupe Francophone du Myelome 
Intervention: Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) 
Start Date: 2015-09 
Last Updated: 2020-12-07 
Number of Patients: 1085 
Recruitment Status: UNKNOWN 
Condition: Multiple Myeloma 

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: NCT03595787

Title: COaching and Prehabilitation: Faisability Study in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome 
Study Summary: This faisability study aims to evaluate the adhesion of the patient to a multidisciplinary program (adapted physical activity, coaching and nutrition) 
Sponsor: Institut Paoli-Calmettes 
Intervention: Coaching and Habilitation 
Start Date: 2022-11-04 
Last Updated: 2023-02-15 
Number of Patients: 50 
Recruitment Status: RECRUITING 
Condition: Acute Myeloid Leukemia 

NCTID: NCT05625087

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

NCTID: NCT04163887

Title: Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases 
Study Summary: The objective of this study is to demonstrate the superiority of the laparoscopic approach over the open approach in the resection of colorectal liver metastases, by examining the reduction of postoperative complications (including mortality), measured using the Comprehensive Complication Index (CCI) within 90 days of the procedure or regardless of the date during the hospital stay. 
Sponsor: Institut Mutualiste Montsouris 
Intervention: hepatectomy 
Start Date: 2021-01-27 
Last Updated: 2022-02-22 
Number of Patients: 340 
Recruitment Status: RECRUITING 
Condition: Liver Metastasis Colon Cancer 

NCTID: NCT02174887

Title: Biological Effect of Nab-paclitaxel Combined to Gemcitabine in Metastatic Pancreatic Cancer 
Study Summary: The prognostic of metastatic pancreatic adenocarcinoma is dismal and the treatment gold standard since the end of the 90s’ is gemcitabine; unfortunately all trials testing combinations of gemcitabine with chemotherapeutic agents or targeted agents had failed to demonstrate any superiority over gemcitabine monotherapy.  In a recently published phase I/II study of combination of gemcitabine plus nab-paclitaxel in patients with metastatic pancreatic adenocarcinoma (PAC), the combination gave an impressive response rate of 48% (Gemcitabine 1g/m² and nab-paclitaxel 125 mg/m² once a week for 3 weeks, every 4 weeks). The safety profile was correct (fatigue, sensory neuropathy, nausea, haematological side effects). This efficacy can be related to an improvement of gemcitabine delivery to the tumor bed, as shown on preclinical studies: the response rate in xenografts was better with the combination; this improvement was associated with an increase of intratumoral gemcitabine concentration in mice receiving the combination when compared to mice receiving gemcitabine alone. This might be associated to modifications of peritumoral stroma with reduction of stromal content and increase in dilated vessels.  The aim of this study is to evaluate if the combination of nab-paclitaxel plus gemcitabine induces a modification in vascularization of pancreatic adenocarcinoma on the primary tumor and of liver metastases after 2 cycles of treatment by comparison to baseline. 
Sponsor: Institut Paoli-Calmettes 
Intervention: Nab-paclitaxel + Gemcitabine 
Start Date: 2014-09 
Last Updated: 2017-03-28 
Number of Patients: 19 
Recruitment Status: COMPLETED 
Condition: Pancreatic Adenocarcinoma 

NCTID: NCT02531737

Title: Nintedanib (Vargatef®) Plus Docetaxel in Second Line of Treatment in Patients With Lung Cancer 
Study Summary: The purpose of this study is to determine whether nintedanib (vargatef®) combined with docetaxel are effective in second line of treatment in patients with no squamous non small cell lung cancer refractory to first line chemotherapy. 
Sponsor: University Hospital, Limoges 
Intervention: vargatef® 
Start Date: 2015-09 
Last Updated: 2021-08-10 
Number of Patients: 59 
Recruitment Status: COMPLETED 
Condition: Lung Neoplasms 

NCTID: NCT01596114

Title: European Stop Tyrosine Kinase Inhibitor Study
Study Summary: The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine Kinase Inhibitor (TKI). Main goal is the assessment of the duration of major molecular response (MMR) or better after stopping TKI therapy.  Secondary goals include:  * Identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping TKI (e.g. level of Complete molecular remission (CMR), risk score, duration of TKI treatment, type of TKI pretreatment) * Evaluation of quality of life (QoL) in patients stopping TKI * Evaluation of medico-economic impact of stopping TKI * Estimating the number of patients in CMR who are eligible for stopping TKI therapy by setting up a screening log * Time to recovery of CMR There will be no randomised comparison. Based on the experience of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month molecular-relapse-free survival probability of at least 40%. An interim analysis will be performed after a pilot phase where 200 patients have been observed for at least six months. Formally, it is planned to test the null hypothesis H0: Six-month molecular relapse-free survival probability P ≤ 40% against the alternative hypothesis H1: Six-month molecular-relapse-free survival probability P > 40%. Eligible are adult CML patients in chronic phase on TKI treatment in CMR for at least one year (> 4 log reduction of BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed by a PCR within a standardized CMR laboratory). Clinical and biological monitoring will be performed during 3 years: Associated scientific projects are performed. Recruitment period: 2 years; follow up: 3 years. Planned patient recruitment in main phase: n=500 
Sponsor: European LeukemiaNet 
Intervention: Stopping treatment with TKI 
Start Date: 2012-05-30 
Last Updated: 2021-11-05 
Number of Patients: 868 
Recruitment Status: COMPLETED 
Condition: Chronic Myeloid Leukemia 

NCTID: NCT03595800

Title: Extension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen 
Study Summary: This study is an extension to younger patients of the currently ongoing national, multicenter, open-label, randomized phase III HAPLOMUDELDERLY which evaluates elderly patients with hematological malignancies, justifying an allo-HSCT from an alternative donor when a MRD has not been identified. It will extend the investigation of these two modalities of allo-HSCT to younger patients which are eligible to RIC. 
Sponsor: Institut Paoli-Calmettes 
Intervention: Hematopoietic stem cells transplantation 
Start Date: 2017-09-19 
Last Updated: 2021-04-01 
Number of Patients: 54 
Recruitment Status: UNKNOWN 
Condition: Acute Leukemia 

NCTID: NCT02810743

Title: Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer 
Study Summary: Investigator-initiated, international, multicentre, randomized, open-label, (neo)adjuvant phase III study in target population (stage III, HER2-negative, BRCA1-like breast cancer patients) comparing optimized standard-dose chemotherapy with intensified, alkylating chemotherapy with stem cell rescue. 
Sponsor: The Netherlands Cancer Institute 
Intervention: ddAC-CP-Olaparib 
Start Date: 2017-01-25 
Last Updated: 2023-11-24 
Number of Patients: 174 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT02701907

Title: EXPRESS: EXcePtional RESponSe - Exceptional and Unexpected Response to Targeted Therapies 
Study Summary: Adult patients with metastatic or locally advanced solid malignancies (including but not limited to breast, cancer, lung adenocarcinoma or squamous cell carcinoma, colorectal cancer, ovarian cancer, renal clear cell cancer, skin cutaneous melanoma), presenting or having presented an exceptional and unexpected response to an antineoplastic targeted therapy. 
Sponsor: UNICANCER 
Intervention: Blood sampling 
Start Date: 2016-12 
Last Updated: 2022-09-07 
Number of Patients: 182 
Recruitment Status: COMPLETED 
Condition: Metastatic Cancers 

NCTID: NCT00003607

Title: Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer 
Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy to the prostate and pelvis is more effective than radiation therapy to the prostate alone in treating prostate cancer.  PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I, stage II, or stage III prostate cancer. 
Sponsor: UNICANCER 
Intervention: radiation therapy 
Start Date: 1997-12 
Last Updated: 2016-06-23 
Number of Patients: 450 
Recruitment Status: COMPLETED 
Condition: Prostate Cancer 

NCTID: NCT02178397

Title: A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR 
Study Summary: The current first line treatment of patients with EGFR activating mutation lung cancer is EGFR TKI. Compared to platinum-based chemotherapy, EGFR-TKIs are superior in terms of response rate and progression-free survival. However, an acquired resistance occurs almost constantly. The second-line treatment includes platinum-based chemotherapy in the absence of contraindication. This chemotherapy is then administered after discontinuing EGFR TKIs.  However, a rebound phenomenon of the disease was described in patients who discontinued EGFR TKIs. Some clinical teams therefore recommend, as a precaution, in order to avoid any withdrawal phenomenon, to never discontinue EGFR TKIs in patients developing an EGFR TKI acquired resistance.  It seems therefore useful to conduct a study to better define the therapeutic strategy to adopt in patients developing an acquired resistance after having received EGFR TKIs as first line treatment. 
Sponsor: Centre Francois Baclesse 
Intervention: ERLOTINIB WITH CHEMOTHERAPY 
Start Date: 2014-06 
Last Updated: 2017-07-17 
Number of Patients: 6 
Recruitment Status: TERMINATED 
Condition: NSCLC Patients With EGFR Activating Mutation 

NCTID: NCT03635567

Title: Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826) 
Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.  The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2018-10-25 
Last Updated: 2023-11-14 
Number of Patients: 617 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Cervical Cancer 

NCTID: NCT00054587

Title: Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer.  PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm). 
Sponsor: UNICANCER 
Intervention: Trastuzumab 
Start Date: 2001-06 
Last Updated: 2013-07-19 
Number of Patients: 3010 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT02947685

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

NCTID: NCT06130787

Title: Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated With Targeted Therapy 
Study Summary: French prospective multicenter, open-label study involving newly diagnosed CML patients. Two assessments will be performed during the follow-up of these patients: individual frailty using geriatric tools and individual biological aging determined by DNA methylation analysis. 
Sponsor: University Hospital, Clermont-Ferrand 
Intervention: Blood and bone marrow sample 
Start Date: 2023-11-15 
Last Updated: 2023-11-14 
Number of Patients: 321 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Leukemia,Myeloid, Chronic 

NCTID: NCT01311687

Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study 
Study Summary: The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma. 
Sponsor: Celgene 
Intervention: pomalidomide 
Start Date: 2011-03-11 
Last Updated: 2018-10-24 
Number of Patients: 455 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT03143322

Title: Standard Treatment +/- SBRT in Solid Tumors Patients With Between 1 and 3 Bone-only Metastases 
Study Summary: Bone metastases occur frequently during the evolution of solid tumors, either isolated or associated with visceral metastases. The incidence varies between 20 and 85% depending on the primary cancer. Breast, prostate, and lung cancers are responsible for 70% of bone metastases. Cancer with bone metastases compared to other metastatic sites is considered as associated with a better prognosis, particularly for breast and prostate cancer. Bone metastases may be present at diagnosis (synchronous metastasis) or appear at a later time (metachronous metastasis).  The concept of “oligometastases” was proposed in patients with about 3 up to 5 metastases (without restriction on the primary site) and associated with an intermediate prognosis. It was hypothesized that local treatment with curative intent, aiming at the few metastatic sites, would yield long-term survival probabilities, along with systemic therapies.  Long-term survivors have been reported after curative-intent treatment of metastasis in sarcoma and colorectal cancers with liver or lung metastasis. We chose to focus on bone metastasis because of their high incidence, their impact on the patient’s quality of life and autonomy, and their accessibility to potentially curative radiotherapy.  The systemic treatment of metastatic cancer includes hormonal therapy (breast and prostate cancer), biologically-targeted drugs and chemotherapy (all cancers).  Stereotactic radiotherapy is a highly accurate technique was initially developed for performing the radiosurgery of brain tumors in patients for whom it was deemed be too difficult to proceed to classical excision surgery. In this process, a high total dose of radiation is delivered in a single fraction to a well-defined intra-cranial target. The concept of radiotherapy in stereotactic conditions was extended to one or several fractions delivered to small volumes primary tumors/ metastases in extra-cranial sites (Stereotactic Body RadioTherapy <math display="block">SBRT</math>). At present, high control rates have been achieved for lung metastases. Similarly, very high local control rates have been reported in bone metastases after stereotactic radiotherapy.  In this protocol, our purpose is to demonstrate, via a randomized phase III trial, that high doses of radiotherapy, delivered in stereotactic conditions to the bone metastases (between 1 and 3 metastases) in solid tumor patients is able to improve the survival without progression. 
Sponsor: UNICANCER 
Intervention: SBRT 
Start Date: 2018-01-24 
Last Updated: 2023-03-24 
Number of Patients: 196 
Recruitment Status: RECRUITING 
Condition: Metastatic Breast Cancer 

NCTID: NCT00820547

Title: Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients 
Study Summary: RATIONALE: Monoclonal antibodies, such as bevacizumab, 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. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab and radiation therapy after surgery may kill any tumor cells that remain after surgery.  PURPOSE: This phase II trial is studying giving bevacizumab together with chemotherapy before surgery and bevacizumab and radiation therapy after surgery to see how well it works in treating patients with inflammatory breast cancer. 
Sponsor: UNICANCER 
Intervention: bevacizumab 
Start Date: 2009-01 
Last Updated: 2019-10-22 
Number of Patients: 100 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT03549715

Title: NEoadjuvant Dose-dense MVAC In cOmbination With Durvalumab and Tremelimumab in Muscle-invasive Urothelial Carcinoma
Study Summary: This is an open label, phase I/II clinical trial to evaluate the efficacy and safety of 2 cycles of durvalumab without (Arm A) or with (Arm B) tremelimumab in association with ddMVAC as neoadjuvant therapy in patients with MIUC. 
Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie 
Intervention: Durvalumab 
Start Date: 2018-12-06 
Last Updated: 2022-04-28 
Number of Patients: 121 
Recruitment Status: RECRUITING 
Condition: Infiltrating Bladder Urothelial Carcinoma 

NCTID: NCT00423475

Title: Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer 
Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the adrenal glands from making androgens. Giving radiation therapy with or without goserelin after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without goserelin in treating prostate cancer.  PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer. 
Sponsor: UNICANCER 
Intervention: goserelin acetate 
Start Date: 2006-10 
Last Updated: 2018-05-17 
Number of Patients: 743 
Recruitment Status: COMPLETED 
Condition: Prostate Cancer 

NCTID: NCT00006050

Title: Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.  PURPOSE: Phase II trial to study the effectiveness of liver perfusion using oxaliplatin plus leucovorin and fluorouracil given by infusion in treating patients who have colorectal cancer that has spread to the liver. 
Sponsor: UNICANCER 
Intervention: FOLFOX regimen 
Start Date: 1999-04-04 
Last Updated: 2021-02-17 
Number of Patients: NA 
Recruitment Status: COMPLETED 
Condition: Colorectal Cancer 

NCTID: NCT04924075

Title: Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015) 
Study Summary: This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan 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: Belzutifan 
Start Date: 2021-08-12 
Last Updated: 2023-11-27 
Number of Patients: 322 
Recruitment Status: RECRUITING 
Condition: Pheochromocytoma/Paraganglioma 

NCTID: NCT00806767

Title: Fludarabine, Busulfan, and Antilymphocyte Globulin Followed by Donor Stem Cell Transplant in Treating Older Patients With Hematological Cancer 
Study Summary: RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient’s stem cells, helps stop the growth of cancer cells. It also stops the patient’s immune system from rejecting the donor’s stem cells. The donated stem cells may replace the patient’s immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can make an immune response against the body’s normal cells. Giving antilymphocyte globulin before transplant may stop this from happening.  PURPOSE: This phase II trial is studying how well fludarabine, busulfan, and antilymphocyte globulin together with donor stem cell transplant works in treating older patients with hematological cancer. 
Sponsor: Institut Paoli-Calmettes 
Intervention: therapeutic immune globulin 
Start Date: 2007-03 
Last Updated: 2011-05-17 
Number of Patients: 82 
Recruitment Status: COMPLETED 
Condition: Chronic Myeloproliferative Disorders 

NCTID: NCT02165397

Title: Ibrutinib With Rituximab in Adults With Waldenström’s Macroglobulinemia 
Study Summary: The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in participants with Waldenström’s macroglobulinemia (WM). 
Sponsor: Pharmacyclics LLC. 
Intervention: Ibrutinib 
Start Date: 2014-07-07 
Last Updated: 2021-03-03 
Number of Patients: 181 
Recruitment Status: COMPLETED 
Condition: Waldenström’s Macroglobulinemia 

NCTID: NCT03217097

Title: MGMT-NET: O6-methylguanine-DNA Methyltransferase (MGMT) Status in Neuroendocrine Tumors: Predictive Factor of Response to Alkylating Agents 
Study Summary: Neuroendocrine tumors (NET) are rare but their incidence is growing. Alkylating agents (ALKY) are one of the main systemic treatments used, at least for advanced duodeno-pancreatic NETs, with a response rate of 30 to 40% and a median progression-free survival of 4 to 18 months. Chemotherapy is one of the few therapeutic weapons, along with everolimus, somatostatin analogs, and metabolic radiotherapy, for lung NETs, called typical and atypical carcinoids, even if the level of proof of efficacy for these treatments is lower than for duodeno-pancreatic NETs. Considering the available retrospective data, O6-Methylguanine-DNA methyltransferase (MGMT) appears to be a predictive factor of the response to ALKY. Oxaliplatin (OX) has demonstrated an interesting activity, with response rates between 17% and 30%. In a first retrospective study we showed that Gemox is effective in NET, and more recently that its activity is similar to that of ALKYs, but without being influenced by the MGMT status. Prospective studies are needed but our data suggests that ALKY should be offered first to patients with methylated MGMT tumors while Oxaliplatin-based chemotherapy should be offered first to patients with unmethylated MGMT tumors.  In this project, we wish to evaluate the contribution of the MGMT methylation, evaluated in the tumor, in predicting the Objective Response (OR) in patients treated with ALKY and to evaluate a treatment with alkylating agents versus Oxaliplatin in patients with a duodeno-pancreatic or lung or unknown primitive NET. 
Sponsor: Hospices Civils de Lyon 
Intervention: Oxaliplatin-based chemotherapy 
Start Date: 2018-10-16 
Last Updated: 2022-11-04 
Number of Patients: 116 
Recruitment Status: COMPLETED 
Condition: Neuroendocrine Tumors 

NCTID: NCT00607854

Title: Safety of Ibritumomab Tiuxetan (Zevalin®) in Combination With a Fludarabine-based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007) 
Study Summary: The purpose of this study is to evaluate the safety and efficacy of Zevalin® in a Reduced Intensity Conditioning regimen followed by allogenic stem cell support in patients with aggressive lymphomas who are responsive to a salvage chemotherapy regimen. 
Sponsor: University Hospital, Bordeaux 
Intervention: Ibritumomab Tiuxetan (Zevalin) 
Start Date: 2008-02 
Last Updated: 2016-10-05 
Number of Patients: 31 
Recruitment Status: COMPLETED 
Condition: Diffuse Large B-Cell Lymphoma 

NCTID: NCT04987203

Title: Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma 
Study Summary: This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI). 
Sponsor: AVEO Pharmaceuticals, Inc. 
Intervention: Tivozanib 
Start Date: 2021-09-09 
Last Updated: 2023-11-28 
Number of Patients: 326 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Renal Cell Carcinoma 

NCTID: NCT01827254

Title: Sutent Rechallenge In mRCC Patients 
Study Summary: Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line. 
Sponsor: Pfizer 
Intervention: sunitinib: observational study 
Start Date: 2013-07 
Last Updated: 2015-04-30 
Number of Patients: 61 
Recruitment Status: COMPLETED 
Condition: Metastatic Renal Cell Carcinoma 

NCTID: NCT02869503

Title: Institut Paoli Calmettes Colorectal Cancer Database 
Study Summary: Database of Institut Paoli-Calmettes patients diagnosed with colorectal cancer 
Sponsor: Institut Paoli-Calmettes 
Intervention: Data collection 
Start Date: 2001-01 
Last Updated: 2016-08-17 
Number of Patients: 22000 
Recruitment Status: RECRUITING 
Condition: Colorectal Neoplasms 

NCTID: NCT00112554

Title: Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia 
Study Summary: RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.  PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how well they work compared to cytarabine alone in treating patients with relapsed acute myeloid leukemia. 
Sponsor: Vion Pharmaceuticals 
Intervention: cytarabine 
Start Date: 2005-03 
Last Updated: 2013-11-06 
Number of Patients: 420 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT00424203

Title: Doxorubicin and Cyclophosphamide in Treating Older Women With Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery 
Study Summary: RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.  PURPOSE: This phase II trial is studying how well giving doxorubicin together with cyclophosphamide works in treating older women with stage I , stage II, or stage III breast cancer that has been removed by surgery. 
Sponsor: UNICANCER 
Intervention: AC regimen 
Start Date: 2006-01 
Last Updated: 2013-09-04 
Number of Patients: 40 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT05403450

Title: A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL) 
Study Summary: The primary purpose of the study is to assess safety, and to identify the recommended phase 2 dose (RP2D) of tolinapant in combination with oral decitabine/cedazuridine in Phase 1 and to assess preliminary efficacy as determined by overall response rate (ORR) in Phase 2. 
Sponsor: Astex Pharmaceuticals, Inc. 
Intervention: Tolinapant 
Start Date: 2022-06-23 
Last Updated: 2023-09-01 
Number of Patients: 132 
Recruitment Status: RECRUITING 
Condition: Relapsed/Refractory Peripheral T-cell Lymphoma 

NCTID: NCT04064359

Title: Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors 
Study Summary: The purpose of this study is to evaluate OBT076, which is a drug that combines an antibody with an anti-cancer drug. This class of drugs are called Antibody-Drug Conjugates (ADC). Antibodies are normally produced in the human body by the immune system to fight infections but can be designed to target cancer cells and deliver an anti-cancer drug. OBT076 is composed of an antibody that targets the CD205 protein on cancer cells and delivers an anti-cancer drug which can kill them. OBT076 is an “Investigational Drug”, which means that it is still being studied and has not yet been approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authorities to be prescribed by doctors for the treatment of metastatic or recurrent solid tumors. The use of OBT076 in this study is investigational.  This is a Phase I research study designed to look at several dose levels of the study drug to find the highest dose level that is safe and well-tolerated (does not cause unacceptable side effects), and to examine the effects of the study drug in a small group of research participants. The study will also look at the effectiveness of OBT076 as an anti-cancer therapy. Once the optimal dose is determined and safety is assessed, additional research participants will be treated at the optimal dose level to further evaluate safety and effectiveness. 
Sponsor: Oxford BioTherapeutics Ltd 
Intervention: OBT076, a CD205-directed antibody-drug conjugate 
Start Date: 2019-07-25 
Last Updated: 2023-10-12 
Number of Patients: 150 
Recruitment Status: RECRUITING 
Condition: Solid Tumor 

NCTID: NCT02279654

Title: Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q) 
Study Summary: This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 <math display="block">del(5q)</math>.  The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree. 
Sponsor: Celgene 
Intervention: Lenalidomide 
Start Date: 2014-12-17 
Last Updated: 2022-08-19 
Number of Patients: 389 
Recruitment Status: COMPLETED 
Condition: Myelodysplastic Syndrome 

NCTID: NCT01199354

Title: Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy (M-RIC) 
Study Summary: The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy and radiotherapy in invasive breast carcinoma. 
Sponsor: Clinique Clementville 
Intervention: Mastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap. 
Start Date: 2010-07 
Last Updated: 2011-06-09 
Number of Patients: 80 
Recruitment Status: UNKNOWN 
Condition: Breast Carcinoma 

NCTID: NCT05453903

Title: A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies 
Study Summary: The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of JNJ-75276617 in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of JNJ-75276617 in combination with AML directed therapies at the RP2D(s) (dose expansion). 
Sponsor: Janssen Research & Development, LLC 
Intervention: JNJ-75276617 
Start Date: 2022-10-04 
Last Updated: 2023-11-09 
Number of Patients: 150 
Recruitment Status: RECRUITING 
Condition: Leukemia, Myeloid, Acute 

NCTID: NCT00776503

Title: Vorinostat and Low Dose Cytarabine for High Risk Myelodysplasia 
Study Summary: The purpose of this study is to determine the maximum tolerated duration and schedule of oral VORINOSTAT in addition to low dose cytarabine in the treatment of Intermediate-2 and High risk myelodysplastic syndromes. 
Sponsor: Groupe Francophone des Myelodysplasies 
Intervention: VORINOSTAT 
Start Date: 2008-05 
Last Updated: 2014-03-20 
Number of Patients: 52 
Recruitment Status: COMPLETED 
Condition: Myelodysplastic Syndromes 

NCTID: NCT02854215

Title: Cost Utility of Radical Surgery in Ovarian Cancer 
Study Summary: The purpose of this study is to investigate the medico-economic impact of adherence to INCa (National Cancer Institute) guidelines in ovarian cancer surgery by assessment of outcome in cost per Quality Adjusted Life Years (QALY). 
Sponsor: Institut Claudius Regaud 
Intervention: Collection of additional data with questionnaires 
Start Date: 2017-01-18 
Last Updated: 2023-08-03 
Number of Patients: 200 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Ovarian Cancer 

NCTID: NCT00103168

Title: Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor 
Study Summary: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after surgery may kill any remaining tumor cells. It is not yet known whether imatinib mesylate is more effective than observation only in treating gastrointestinal stromal tumor.  PURPOSE: This randomized phase III trial is studying imatinib mesylate to see how well it works compared to observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumor. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: imatinib mesylate 
Start Date: 2004-12 
Last Updated: 2018-07-09 
Number of Patients: 908 
Recruitment Status: COMPLETED 
Condition: Gastrointestinal Stromal Tumor 

NCTID: NCT00104715

Title: Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer 
Study Summary: RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer.  PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer. 
Sponsor: UNICANCER 
Intervention: antiandrogen therapy 
Start Date: 2004-10-18 
Last Updated: 2021-02-21 
Number of Patients: 385 
Recruitment Status: COMPLETED 
Condition: Prostate Cancer 

NCTID: NCT04968015

Title: Venetoclax + Cytarabine Versus Idarubicin + Cytarabine : Efficacity Assessment as Post-remission Therapy to Elderly Patients With Acute Myeloid Leukemia in First Remission 
Study Summary: For the FILO group, the standard of care for induction chemotherapy of elderly fit patients with AML is represented by the combination of Cytarabine, Idarubicin and Lomustine. The superiority of this combination was confirmed in a larger prospective study the LAMSA-2007. This induction treatment, followed by six courses of consolidation (Idarubicin and Cytarabine) followed then by a period of 6-month maintenance therapy, allows up to 80 % of remission, and a RFS of 46 % at 2 years.  The aim of the study is to assess the efficacy on outcome of Venetoclax combined with Cytarabine versus Idarubicin combined with Cytarabine administered as post-remission therapy to elderly patients with acute myeloid leukemia in first complete remission (CR) following induction chemotherapy. 
Sponsor: French Innovative Leukemia Organisation 
Intervention: Cytarabine-Venetoclax Association 
Start Date: 2022-05-25 
Last Updated: 2023-09-08 
Number of Patients: 134 
Recruitment Status: RECRUITING 
Condition: Acute Myeloid Leukemia 

NCTID: NCT03957915

Title: Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia 
Study Summary: This Phase 1 Study is an open-label, non-randomized, dose escalation, safety, efficacy, pharmacokinetic, and pharmacodynamic evaluation study of INA03 administered as a single agent IV infusion every 2 weeks to patients ≥18 years of age with R/R AML, MLL, or ALL.  The study will be performed in 2 parts: a Dose Titration for Day 1 study (Part 1) followed by a Dose Escalation Part (Part 2) of INA03 used as monotherapy. 
Sponsor: Institut Paoli-Calmettes 
Intervention: INA03 administration 
Start Date: 2020-05-29 
Last Updated: 2023-02-15 
Number of Patients: 34 
Recruitment Status: RECRUITING 
Condition: Acute Lymphoblastic Leukemia Recurrent 

NCTID: NCT02345915

Title: Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia 
Study Summary: Taking into account the specificities of adolescent and young adult cancer patients led agencies (in particular the French National Cancer Institute INCa, through the last Cancer Plan), to initiate projects targeting this population. Acute leukemia is among the most common cancers in adolescents and young adults. Recent therapeutic advances now allow hope for a cure in about 50% of this population. The issue of post-cancer is therefore of particular importance for young adults with cancer. Our aim is to establish the health determinants in young adult leukemia survivors and to compare the frequency of these effects and their explanatory factors to the data collected in children or adolescent leukemia survivors program (LEA). 90 patients followed up at the Institut Paoli-Calmettes cancer center and Nice University Hospital have been identified and would be included in this study.Collected data will include information on the initial disease and its treatments, physical sequelae (fertility, thyroid function, heart function, visual function, secondary tumors, viral infections, lung function, bone metabolism, iron metabolism, metabolic syndrome, osteonecrosis, alopecia … ), quality of life, social and occupational integration and relationship with care system. 
Sponsor: Institut Paoli-Calmettes 
Intervention: Blood sample 
Start Date: 2014-11 
Last Updated: 2017-09-05 
Number of Patients: 90 
Recruitment Status: UNKNOWN 
Condition: Leukemia, Myeloid, Acute 

NCTID: NCT02361515

Title: Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid 
Study Summary: The present randomized, open, multicentric Phase II trial, in parallel groups with two arms of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space between the prostate and the rectum to preserve the rectal-wall from high doses of irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2 induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after an injection of hyaluronic acid between the rectal wall and the prostate.  Ninety-six patients and 9 centers are included in the protocol. 
Sponsor: Hospices Civils de Lyon 
Intervention: Moderate hypofractionated radiotherapy 
Start Date: 2015-03 
Last Updated: 2022-03-17 
Number of Patients: 96 
Recruitment Status: COMPLETED 
Condition: Prostatic Adenocarcinoma 

NCTID: NCT04428554

Title: Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy 
Study Summary: This is a phase II, multicenter, randomized open-label and comparative study designed to evaluate whether local consolidative radiotherapy plus standard of care improves overall survival as compared to standard of care in patients with limited metastatic urothelial bladder cancer and without progression following the initial phase of first-line systemic therapy.  Each patient will be followed during 4 years from the date of randomization. 
Sponsor: Institut Claudius Regaud 
Intervention: Experimental arm 
Start Date: 2020-06-30 
Last Updated: 2023-09-21 
Number of Patients: 130 
Recruitment Status: RECRUITING 
Condition: Urothelial Bladder Cancer 

NCTID: NCT00275054

Title: Rituximab, Fludarabine, and Cyclophosphamide or Observation Alone in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia 
Study Summary: RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving rituximab together with fludarabine and cyclophosphamide is more effective than observation alone in treating chronic lymphocytic leukemia.  PURPOSE: This randomized phase III trial is studying rituximab, fludarabine, and cyclophosphamide to see how well they work compared to observation alone in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia. 
Sponsor: German CLL Study Group 
Intervention: Fludarabine 
Start Date: 2005-10 
Last Updated: 2019-05-23 
Number of Patients: 825 
Recruitment Status: COMPLETED 
Condition: Chronic Lymphocytic Leukemia 

NCTID: NCT04172675

Title: A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) 
Study Summary: The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator’s Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy. 
Sponsor: Janssen Research & Development, LLC 
Intervention: Erdafitinib 
Start Date: 2020-02-28 
Last Updated: 2023-11-13 
Number of Patients: 107 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Urinary Bladder Neoplasms 

NCTID: NCT04802590

Title: Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma 
Study Summary: The OASIS II trial is a multicentre, open label, randomized phase II trial. We will compare the efficacy of Ibrutinib/anti-CD20 Ab versus Ibrutinib/anti-CD20 Ab/Venetoclax given as fixed duration combinations in newly diagnosed Mantle Cell Lymphoma (MCL) patients (≥ 18 years and < 80 years of age).  Treatment duration of Ibrutinib and Venetoclax will be a maximum of two years. Patients will be treated with CD20 Ab for 3.5 years.  The primary aim is to assess MRD status at 6 months in both arms. 
Sponsor: The Lymphoma Academic Research Organisation 
Intervention: Ibrutinib 560 mg 
Start Date: 2022-01-24 
Last Updated: 2023-03-17 
Number of Patients: 194 
Recruitment Status: RECRUITING 
Condition: Mantle Cell Lymphoma 

NCTID: NCT02869490

Title: Institut Paoli Calmettes Cervical Cancer Database 
Study Summary: Database of Institut Paoli-Calmettes patients diagnosed with cervical cancer 
Sponsor: Institut Paoli-Calmettes 
Intervention: Data collection 
Start Date: 2002-01 
Last Updated: 2016-08-17 
Number of Patients: 6000 
Recruitment Status: RECRUITING 
Condition: Uterine Cervical Neoplasms 

NCTID: NCT00089856

Title: GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer 
Study Summary: The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past. 
Sponsor: Cell Genesys 
Intervention: Immunotherapy with allogeneic prostate vaccine 
Start Date: 2004-07 
Last Updated: 2008-11-05 
Number of Patients: 626 
Recruitment Status: TERMINATED 
Condition: Prostate Cancer 

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: NCT00405743

Title: A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies 
Study Summary: Patients with refractory or relapsed hematologic malignancies will receive CP-4055 intravenously(IV) on Day 1-5 every three weeks until complete response or disease worsening/progressing 
Sponsor: Clavis Pharma 
Intervention: CP-4055 
Start Date: 2006-05 
Last Updated: 2013-09-18 
Number of Patients: 153 
Recruitment Status: COMPLETED 
Condition: Hematologic Malignancies 

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: NCT04827719

Title: BST-236 as a Single Agent in Adults With Relapsed or Refractory AML or HR-MDS 
Study Summary: To assess the efficacy, and safety of BST-236 in patients unfit for intensive chemotherapy with AML or HR MDS that failed or relapsed following first line therapy 
Sponsor: Groupe Francophone des Myelodysplasies 
Intervention: BST-236 
Start Date: 2021-05-01 
Last Updated: 2023-01-04 
Number of Patients: 40 
Recruitment Status: RECRUITING 
Condition: Myelodysplastic Syndromes 

NCTID: NCT01564056

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

NCTID: 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: NCT01232556

Title: A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
Study Summary: The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator’s choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival. 
Sponsor: Pfizer 
Intervention: Inotuzumab ozogamicin 
Start Date: 2011-04-04 
Last Updated: 2019-01-08 
Number of Patients: 338 
Recruitment Status: TERMINATED 
Condition: Lymphoma, Non-Hodgkin 

NCTID: NCT02383251

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

NCTID: NCT03961451

Title: Number of Weekly Steps, Fatigue, Quality of Life, Well-being During Cancer Treatment: Impact of Recommendations Strengthened by the Provision of Web Interface and Tele-coaching. 
Study Summary: study to correlate this level of objective physical activity with the levels of fatigue and quality of life in cancer patient being treated. 
Sponsor: Institut Paoli-Calmettes 
Intervention: Podometer 
Start Date: 2016-01-01 
Last Updated: 2019-05-23 
Number of Patients: 60 
Recruitment Status: COMPLETED 
Condition: Cancer, Treatment-Related 

NCTID: NCT01393756

Title: Revlimid Dose 25 mg in Association With (R-CHOP) in the Treatment Follicular Lymphoma 
Study Summary: The purpose of the study is to assess the efficacy of the association of Lenalidomide (Revlimid) and R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, vincristine and Prednisone) in a population of patients with follicular lymphoma as measured by the response rate at the end of treatment. 
Sponsor: The Lymphoma Academic Research Organisation 
Intervention: Lenalidomide and R-CHOP 
Start Date: 2010-12 
Last Updated: 2021-07-26 
Number of Patients: 80 
Recruitment Status: COMPLETED 
Condition: Follicular Lymphoma 

NCTID: NCT04300556

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

NCTID: NCT02320656

Title: Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015 
Study Summary: HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies.  HEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic, pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by collecting, at diagnosis and/or complete remission and/or relapse:  * tumor samples: marrow aspiration, blood sampling. * non-tumor samples: skin biopsy, buccal swab . from 650 patients treated at our cancer center. 
Sponsor: Institut Paoli-Calmettes 
Intervention: Blood sampling 
Start Date: 2014-05 
Last Updated: 2018-07-26 
Number of Patients: 650 
Recruitment Status: RECRUITING 
Condition: Acute Leukemia 

NCTID: NCT04300647

Title: A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent). 
Sponsor: Hoffmann-La Roche 
Intervention: Tiragolumab 
Start Date: 2020-06-30 
Last Updated: 2023-11-18 
Number of Patients: 172 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Cervical Cancer 

NCTID: NCT05201547

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

NCTID: NCT03818685

Title: Evaluate the Clinical Benefit of a Post-operative Treatment Associating Radiotherapy + Nivolumab + Ipilimumab Versus Radiotherapy + Capecitabine for Triple Negative Breast Cancer Patients With Residual Disease 
Study Summary: To evaluate the clinical benefit of a post-operative adjuvant therapy combining radiotherapy + Nivolumab + Ipilimumab versus radiotherapy + Capecitabine in Triple Negative Breast Cancer (TNBC) patients with residual disease after neoadjuvant chemotherapy. 
Sponsor: Centre Leon Berard 
Intervention: Nivolumab 
Start Date: 2019-07-02 
Last Updated: 2023-05-06 
Number of Patients: 95 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT01460186

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

NCTID: NCT00540956

Title: Natural Killer Cells in Older Patients With Acute Myeloid Leukemia 
Study Summary: RATIONALE: Studying natural killer cells in samples of blood from patients with cancer may help doctors find out how these cells are effected by chemotherapy.  PURPOSE: This clinical trial is studying natural killer cells in older patients with acute myeloid leukemia. 
Sponsor: Institut Paoli-Calmettes 
Intervention: cytarabine 
Start Date: 2006-11 
Last Updated: 2011-05-16 
Number of Patients: 40 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT04629443

Title: Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia 
Study Summary: The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S64315 with azacitidine in patients with acute myeloid leukaemia. 
Sponsor: Institut de Recherches Internationales Servier 
Intervention: S 64315 (also referred as MIK665) and azacitidine 
Start Date: 2021-02-17 
Last Updated: 2023-07-25 
Number of Patients: 17 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Acute Myeloid Leukaemia 

NCTID: NCT00373425

Title: A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors 
Study Summary: This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients. 
Sponsor: OSI Pharmaceuticals 
Intervention: Erlotinib 
Start Date: 2006-09 
Last Updated: 2015-09-17 
Number of Patients: 1252 
Recruitment Status: COMPLETED 
Condition: Non-small Cell Lung 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: NCT01956812

Title: Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer 
Study Summary: The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen). 
Sponsor: Gilead Sciences 
Intervention: IMMU-107 
Start Date: 2013-12 
Last Updated: 2021-08-16 
Number of Patients: 334 
Recruitment Status: TERMINATED 
Condition: Metastatic Pancreatic 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: NCT02227251

Title: Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) 
Study Summary: A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic options of demonstrated clinical benefit. 
Sponsor: Karyopharm Therapeutics Inc 
Intervention: Selinexor 
Start Date: 2014-11 
Last Updated: 2023-08-07 
Number of Patients: 244 
Recruitment Status: RECRUITING 
Condition: Diffuse Large B-cell Lymphoma 

NCTID: NCT02861651

Title: Molecular Characterization of Acute Erythroid Leukemia (M6-AML) Using Targeted Next-generation Sequencing 
Study Summary: Acute erythroid leukemia (AEL) is a morphologically distinct, infrequent (o5%) acute myeloid leukemia (AML) designed as M6 in the French- American-British (FAB) classification. The World Health Organization classification recognizes two subclasses, M6a, a leukemia with myeloid blast cells, and M6b, a very rare, purely erythroid AML. It may be difficult to distinguish between a myelodysplastic syndrome and AEL because of the erythroblastic proliferation, which is increased when dysplasia is present. No recurrent cytogenetic abnormality is specific of AEL and the prognosis is poor with a median survival of 17 months. A study of 14 genes in a series of 92 cases has shown that mutations are frequent in AEL and somewhat differ from the other AMLs by the lower and higher proportion of FLT3-ITD and TP53 mutations, respectively. Only three cases of AEL are reported in the TCGA database. To further characterize AEL, determine whether it constitutes a distinct class of AML and document the reasons for its poor prognosis, the investigators will search for molecular alterations in 40 M6a-AMLs using array comparative genomic hybridization (aCGH) and next-generation sequencing (NGS) of 106 genes known or suspected to have a role in myeloid malignancies or in erythrocyte differentiation. 
Sponsor: Institut Paoli-Calmettes 
Intervention: DNA sequencing 
Start Date: 2014-03 
Last Updated: 2016-08-10 
Number of Patients: 40 
Recruitment Status: COMPLETED 
Condition: Acute Myeloid Leukemia 

NCTID: NCT03960112

Title: Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference
Study Summary: To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference 
Sponsor: Institut Paoli-Calmettes 
Intervention: mpMRI 
Start Date: 2020-10-01 
Last Updated: 2020-07-28 
Number of Patients: 150 
Recruitment Status: UNKNOWN 
Condition: Prostate Cancer 

NCTID: NCT04888312

Title: Safety and Efficacy of Mitazalimab in Combination With Chemotherapy in Pancreatic Cancer Patients 
Study Summary: Phase 1b/2 study to assess the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma. 
Sponsor: Alligator Bioscience AB 
Intervention: CD40 agonist mitazalimab in combination with chemotherapy 
Start Date: 2021-09-17 
Last Updated: 2023-10-06 
Number of Patients: 70 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Pancreatic Ductal Adenocarcinoma 

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: NCT02921919

Title: Open-Label Extension and Safety Study of Talazoparib
Study Summary: This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies. 
Sponsor: Pfizer 
Intervention: Talazoparib 
Start Date: 2016-11-08 
Last Updated: 2022-08-24 
Number of Patients: 120 
Recruitment Status: COMPLETED 
Condition: Cancer 

NCTID: NCT04209855

Title: A Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression 
Study Summary: This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator’s choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay. 
Sponsor: ImmunoGen, Inc. 
Intervention: Mirvetuximab Soravtansine 
Start Date: 2019-12-31 
Last Updated: 2023-03-06 
Number of Patients: 453 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Epithelial Ovarian Cancer 

NCTID: NCT00634725

Title: Gemcitabine With or Without Capecitabine and/or Radiation Therapy or Gemcitabine With or Without Erlotinib in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
Study Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which regimen of chemotherapy with or without erlotinib and/or radiation therapy is most effective in treating pancreatic cancer.  PURPOSE: This randomized phase III trial is studying giving gemcitabine together with or without capecitabine and/or radiation therapy to see how well it works compared with giving gemcitabine together with or without erlotinib in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery. 
Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group 
Intervention: capecitabine 
Start Date: 2008-02 
Last Updated: 2015-12-11 
Number of Patients: 820 
Recruitment Status: COMPLETED 
Condition: Pancreatic Cancer 

NCTID: NCT02869555

Title: Institut Paoli Calmettes Multiple Myeloma Database 
Study Summary: Database of Institut Paoli-Calmettes patients diagnosed with multiple myeloma 
Sponsor: Institut Paoli-Calmettes 
Intervention: Data collection 
Start Date: 2010-01 
Last Updated: 2016-08-17 
Number of Patients: 5000 
Recruitment Status: RECRUITING 
Condition: Multiple Myeloma 

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: NCT02963155

Title: Study of Natural Killer Cells in Patients With Metastatic Prostate Cancer: Relationship With Survival and Response Time to Castration
Study Summary: Prospective research of Natural Killer cells as predictive biomarkers to stratify patients likely to have longer response time to castration. 
Sponsor: Institut Paoli-Calmettes 
Intervention: Blood samples 
Start Date: 2016-11 
Last Updated: 2020-01-10 
Number of Patients: 30 
Recruitment Status: UNKNOWN 
Condition: Metastatic Prostate Cancer 

NCTID: NCT03993912

Title: Compare Lenalidomide and Subcutaneous Daratumumab vs Lenalidomide and Dexamethasone in Frail Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy 
Study Summary: This is a Phase 3, randomized (study drug assigned by chance), open-label (participants and researchers are aware about the treatment, participants are receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel-group (each group of participants will be treated at the same time), and multicenter (when more than one hospital team work on a medical research study) study in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) and who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT). The primary hypothesis of this study is that subcutaneous Daratumumab in combination with Lenalidomide will prolong progression-free survival and likely induce less toxicity as compared with Lenalidomide and dexamethasone, in elderly frail subjects with newly diagnosed Multiple myeloma who are ineligible for high dose chemotherapy and ASCT 
Sponsor: University Hospital, Lille 
Intervention: Daratumumab SC in combination with Lenalidomide 
Start Date: 2019-10-17 
Last Updated: 2022-04-29 
Number of Patients: 294 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT03463655

Title: Serum-Ascites Albumin Gradient Analysis in Cancer Patients in Palliative Care 
Study Summary: Current recommendations do not recommend the concomitant administration of albumin after ascites puncture in patients with ascites neoplasia unlike cirrhotic ascites. The etiology of ascites in cancer patients is multifactorial, particularly by hepatic invasion that can lead to ascites loaded with albumin. Ascites punctures therefore lead to undernutrition, recurrent early ascites by decreasing the oncotic pressure by hypo albuminemia and a state of anasarca affecting the quality of life. 
Sponsor: Institut Paoli-Calmettes 
Intervention: cirrhotic albumin 
Start Date: 2017-12-21 
Last Updated: 2018-03-13 
Number of Patients: 50 
Recruitment Status: UNKNOWN 
Condition: Solid Cancer in a Palliative Situation With Ascites 

NCTID: NCT01578655

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

NCTID: NCT01563133

Title: Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas 
Study Summary: This study focuses on three different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract and pancreatic masses.  On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses and Lymph nodes are less developed.  The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on pancreatic masses and lymph nodes. Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making. For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by: Ruling out malignancy for patients with benign appearing nCLE images. Characterizing more malignant tumors in the pancreas. Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during EUS-FNA procedures is feasible and that descriptive criteria can be defined to further differentiate the different types of lesions. 
Sponsor: Mauna Kea Technologies 
Intervention: EUS-FNA 
Start Date: 2012-06 
Last Updated: 2017-08-29 
Number of Patients: 330 
Recruitment Status: UNKNOWN 
Condition: Pancreatic Cyst 

NCTID: NCT02562443

Title: Controlled Study of Rigosertib Versus Physician’s Choice of Treatment in MDS Patients After Failure of an HMA 
Study Summary: The study’s primary objective in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC), is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician’s Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk. 
Sponsor: Onconova Therapeutics, Inc. 
Intervention: rigosertib 
Start Date: 2015-12-02 
Last Updated: 2022-09-26 
Number of Patients: 372 
Recruitment Status: TERMINATED 
Condition: Myelodysplastic Syndrome 

NCTID: NCT00003652

Title: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: This randomized phase III trial is studying different regimens of giving combination chemotherapy together with radiation therapy and comparing how well they work in treating patients with stage II or stage III anal cancer. 
Sponsor: UNICANCER 
Intervention: cisplatin 
Start Date: 1999-01-04 
Last Updated: 2021-02-17 
Number of Patients: 350 
Recruitment Status: COMPLETED 
Condition: Anal Cancer 

NCTID: NCT05917405

Title: Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT 
Study Summary: Relapse remains the main cause of death in patients with myeloid malignancies, especially after an allotransplant. Using drugs with higher anti-leukemic activity as part of the conditioning regimen is one of the strategies to decrease relapse incidence in this population. Retrospective studies have shown that clofarabine can achieve impressive results compared to the use of fludarabine in acute myeloid leukemia (AML) as part of the conditioning regimen. Confirming such results in a prospective manner would definitely establish the CloB2A2 as a superior reduced-intensity conditioning (RIC) regimen compared to the FB2A2 for AML patients.302 AML patients (151 in each arm) in complete remission at transplant will be included with the main objective to demonstrate a significant better 2-year overall survival for CloB2A2 cases (70% vs 55%). A cost-utility analysis and a cost-effectiveness analysis will be also performed as well as an assessment of the quality of life after transplant. Clofarabine will be furnished to all centers. The duration of the study will be 5 years with 3 years of inclusion and 2 years of follow-up for each patient. 
Sponsor: Nantes University Hospital 
Intervention: Fludarabine 
Start Date: 2023-09-14 
Last Updated: 2023-11-15 
Number of Patients: 302 
Recruitment Status: RECRUITING 
Condition: Acute Myeloid Leukemia in Remission 

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: NCT03324282

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

NCTID: NCT02983045

Title: A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors 
Study Summary: In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214 + nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet combination at dosing schedules from Part 3. 
Sponsor: Nektar Therapeutics 
Intervention: Dose Escalation Doublet: Combination of NKTR-214 + nivolumab 
Start Date: 2016-12-19 
Last Updated: 2023-03-13 
Number of Patients: 557 
Recruitment Status: COMPLETED 
Condition: Melanoma 

NCTID: NCT06045806

Title: A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation 
Study Summary: The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT). 
Sponsor: Bristol-Myers Squibb 
Intervention: idecabtagene vicleucel 
Start Date: 2023-10-16 
Last Updated: 2023-11-07 
Number of Patients: 618 
Recruitment Status: RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT02379845

Title: NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Randomized Patients in Two Arms With Soft Tissue Sarcoma of the Extremity and Trunk Wall 
Study Summary: RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering surgery more feasible or easier and achieve better local control of the tumor.  PURPOSE: This phase II/III is a prospective randomized, multi-center, open-label and active controlled two arms study in patients with locally advanced soft tissue sarcoma (STS) of the extremity and trunk wall. Patients will be randomized to receive either NBTXR3 as intratumor injection, activated by external beam radiation therapy or external beam radiation therapy alone, as preoperative treatment. Once the radiotherapy treatment is completed, tumor surgery will be performed in all patients. 
Sponsor: Nanobiotix 
Intervention: NBTXR3 
Start Date: 2015-03-03 
Last Updated: 2021-04-06 
Number of Patients: 180 
Recruitment Status: COMPLETED 
Condition: Adult Soft Tissue Sarcoma 

NCTID: NCT00802568

Title: Fludarabine, Busulfan, Antithymocyte Globulin, and Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma That Has Not Responded to Treatment 
Study Summary: RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient’s immune system from rejecting the donor’s stem cells. The donated stem cells may replace the patient’s immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).  PURPOSE: This phase II trial is studying the side effects of giving fludarabine together with busulfan and antithymocyte globulin followed by donor stem cell transplant and to see how well it works in treating patients with multiple myeloma that has not responded to treatment. 
Sponsor: Institut Paoli-Calmettes 
Intervention: anti-thymocyte globulin 
Start Date: 2007-04 
Last Updated: 2011-05-16 
Number of Patients: 48 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma and Plasma Cell Neoplasm 

NCTID: NCT00003682

Title: Methylprednisolone With or Without Doxorubicin in Treating Patients With Metastatic Prostate Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to make cancer cells stop dividing so they stop growing or die. Combining chemotherapy with corticosteroids may be an effective treatment for prostate cancer.  PURPOSE: Randomized phase III trial to compare the effectiveness of methylprednisolone with or without doxorubicin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy. 
Sponsor: UNICANCER 
Intervention: doxorubicin hydrochloride 
Start Date: 1998-10 
Last Updated: 2016-06-23 
Number of Patients: 160 
Recruitment Status: TERMINATED 
Condition: Prostate Cancer 

NCTID: NCT02730416

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

NCTID: NCT05009927

Title: Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten) 
Study Summary: This is a 2 arms study concerning patients under imatinib treatment for at least 10 years of treatment with locally advanced/metastatic GIST.  In the first arm, patients will discontinue Imatinib treatment. This arm will allow to determine if the re-introduction of Imatinib at relapse is still an efficient treatment for the control of disease.  In the second arm, patients will continue Imatinib treatment, allowing to determine if the continuation of this treatment is efficient for disease control, by the rate of non-progression disease. 
Sponsor: Centre Leon Berard 
Intervention: Imatinib tablets 
Start Date: 2022-01-03 
Last Updated: 2023-09-01 
Number of Patients: 50 
Recruitment Status: RECRUITING 
Condition: Metastatic Gastrointestinal Stromal Tumor (GIST) 

NCTID: NCT02684006

Title: A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) 
Study Summary: This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma 
Sponsor: Pfizer 
Intervention: Avelumab (MSB0010718C) 
Start Date: 2016-03-23 
Last Updated: 2023-11-09 
Number of Patients: 888 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Renal Cell Cancer 

NCTID: NCT05782127

Title: Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes 
Study Summary: This phase I/II open-label, dose-finding, multi-center study will assess safety and primary efficacy of Onureg and Venetoclax combination, to define the optimal biological dose and optimal treatment duration of Onureg to be used along with Venetoclax for further studies in previously untreated patients with higher-risk myelodysplastic syndromes (HR-MDS) not eligible to transplant. 
Sponsor: Groupe Francophone des Myelodysplasies 
Intervention: Onureg + Venetoclax 
Start Date: 2023-11 
Last Updated: 2023-10-26 
Number of Patients: 36 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Untreated Myelodysplastic Syndrome 

NCTID: NCT03828227

Title: QoL in mCRC Elderly Patients Receiving First-line Therapy Based on Simplified Geriatric Parameters. 
Study Summary: A national, multicenter, open-label, randomized phase III study. The trial aim is to determine the best therapeutic strategies according with the HRQoL. 
Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group 
Intervention: OPTIMOX-bevacizumab 
Start Date: 2019-06-07 
Last Updated: 2023-06-28 
Number of Patients: 188 
Recruitment Status: RECRUITING 
Condition: Elderly Patients 

NCTID: NCT01939327

Title: Safety and Efficacy of Revlimid® (Lenalidomide) With Mabthera® (Rituximab) in Non-Hodgkin’s Lymphoma 
Study Summary: The incidence of non-Hodgkin’s lymphoma (NHL) is steadily increasing worldwide. At present, it is the sixth most commonly diagnosed cancer in France, with 10 000 estimated new cases and 5200 deaths annually. An increasing NHL incidence at a rate of 3-4% per year was observed for the 1970s and 1980s. This stabilized in the 1990s, nevertheless still with an annual rise of 1-2%, resulting in almost a doubling of the NHL incidence during last 40 years. This rise has been noted worldwide, particularly in elderly persons >55 years. Increases in high-grade NHL and extranodal disease are predominant. There is about 80% of B-cell histology, approximately 90% of follicular lymphomas and about 70% of aggressive lymphoma patients present with disseminated disease at diagnosis. The prognosis of NHL depends on the histological type, stage and treatment. Indolent lymphomas have a relatively good prognosis with survival time as long as 10 years, but they are usually incurable in advanced stages. Aggressive NHL constitutes about 50% of all cases of NHL in Western Europe. Approximately 50 - 60% of these patients can be cured with immuno-chemotherapy regiments. Subsequently, almost 50% of patients will eventually relapse or become refractory to treatment. The prognosis for patients with refractory or relapsed aggressive NHL is generally poor. The response rates to salvage therapy regimens range from 20 to 40%. Patients who present with refractory disease have the worst prognosis, with a median survival of less than six months. Only a minority of patients can be given high dose chemotherapy, the majority being ineligible due to disease progression.  By modulating the immune system through dendritic cells and NK cells, by changing the cytokine milieu, and by their anti-angiogenic effects, IMiDs in combination with mabthera (rituximab) resulted in augmented in vitro and vivo antitumor effects against B-cell lymphoma.  As concerns the timing of administration and doses of medications, phase I/II studies are ongoing with R-CHOP in combination with Revlimid (Lenalidomide) in DLBCL. The latest presentation is by Nowakowski et al. at ASCO meeting in June 2010. This study determined the maximum tolerated dose of Revlimid(Lenalidomide)administered on days 1-10 with standard R-CHOP (R2-CHOP). NO DLT was found and 25 mg of Revlimid(Lenalidomide)was the recommended dose for phase II with enrollment of 32 patients. These encouraging results permit to introduce in our much less toxic protocol 25 mg of Revlimid(Lenalidomide)as initial dose, with progressive reduction in case of toxicity.  As regards the dose and timing of Mabthera(Rituximab), in DLBCL it was traditionally used as a single 375 mg/m2 injection/cycle. Pre-clinical data suggests that for the optimal NK enhancement Revlimid(Lenalidomide)must be administrated several days (approx. 7 days) before Mabthera(Rituximab)injection. So, our protocol provides Mabthera(Rituximab)IV administration at day 7 of Revlimid(Lenalidomide).  Performed parallel biological investigation of NK status will permit to confirm this hypothesis with possible correction of timing and number of administrations of Mabthera(Rituximab)par cycle. 
Sponsor: Institut Paoli-Calmettes 
Intervention: Lenalidomide/Rituximab 
Start Date: 2013-09 
Last Updated: 2020-05-11 
Number of Patients: 34 
Recruitment Status: COMPLETED 
Condition: Non-Hodgkin Lymphoma 

NCTID: NCT04736706

Title: A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) 
Study Summary: The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).  The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-04-14 
Last Updated: 2023-11-24 
Number of Patients: 1653 
Recruitment Status: RECRUITING 
Condition: Carcinoma, Renal Cell 

NCTID: NCT00003627

Title: Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx
Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to preserve the part of the body where the cancer started. It is not yet known whether radiation therapy with combination chemotherapy is more effective than radiation therapy alone in treating cancer of the oropharynx or hypopharynx that cannot be surgically removed.  PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin and fluorouracil with radiation therapy alone in treating patients who have advanced cancer of the oropharynx or hypopharynx that cannot be surgically removed. 
Sponsor: UNICANCER 
Intervention: cisplatin 
Start Date: 1998-10 
Last Updated: 2021-02-21 
Number of Patients: 160 
Recruitment Status: COMPLETED 
Condition: Head and Neck Cancer 

NCTID: NCT02973217

Title: Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer 
Study Summary: Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size.  The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction of the imILT treatment method in patients diagnosed with pancreatic cancer. The purpose is also to investigate the functionality and safety as well as understanding of the subsequent immunological effects.  This trial is prospective, open and non-randomized. Five patients diagnosed with pancreatic cancer will be treated in this trial, which is estimated to be carried out during a time period of 36 months. 
Sponsor: Clinical Laserthermia Systems AB 
Intervention: Immunostimulating Interstitial Laser Thermotherapy 
Start Date: 2016-10 
Last Updated: 2020-12-17 
Number of Patients: 5 
Recruitment Status: COMPLETED 
Condition: Neoplasms Pancreatic 

NCTID: NCT01376752

Title: Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment 
Study Summary: CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial ovarian cancer is able to improve the median Overall Survival (OS) by 12 months. In that hypothesis, with alpha risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years follow-up, the number of patients to include is 404. Taking into account a 10% failure, an overall number of 444 patients is required. 
Sponsor: UNICANCER 
Intervention: Maximal cytoreductive surgery 
Start Date: 2011-04-26 
Last Updated: 2023-04-04 
Number of Patients: 415 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Ovarian Epithelial Cancer Recurrent 

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: NCT01810705

Title: GRASPA Treatment for Patients With Acute Myeloblastic Leukemia 
Study Summary: The protocol aims at adding GRASPA (L-asparaginase encapsulated in red blood cells, eryaspase) to standard chemotherapy (low-dose cytarabine) to treat patients older than 65 years diagnosed with AML and unfit for intensive chemotherapy. 
Sponsor: ERYtech Pharma 
Intervention: GRASPA 
Start Date: 2013-02 
Last Updated: 2022-02-21 
Number of Patients: 123 
Recruitment Status: COMPLETED 
Condition: Acute Myeloid Leukemia 

NCTID: NCT01818752

Title: Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma 
Study Summary: The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP). 
Sponsor: Amgen 
Intervention: Carfilzomib 
Start Date: 2013-07-08 
Last Updated: 2019-08-26 
Number of Patients: 955 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT00848926

Title: A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma 
Study Summary: This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma. 
Sponsor: Seagen Inc. 
Intervention: brentuximab vedotin 
Start Date: 2009-02 
Last Updated: 2017-03-13 
Number of Patients: 102 
Recruitment Status: COMPLETED 
Condition: Disease, Hodgkin 

NCTID: NCT05696626

Title: Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation 
Study Summary: The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation.  The main question the study aims to answer is:  • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day. 
Sponsor: Sermonix Pharmaceuticals Inc. 
Intervention: Lasofoxifene in combination with abemaciclib 
Start Date: 2023-10-31 
Last Updated: 2023-11-14 
Number of Patients: 400 
Recruitment Status: RECRUITING 
Condition: Metastatic Breast Cancer 

NCTID: NCT01934452

Title: Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients 
Study Summary: This prospective study will investigate the characteristics of mRCC patients at time of CR in comparison with mRCC patients non on CR treated with Sunitinib, in order to provide some answers/ refection leads to the following questions :  Can we identify blood specificity at time of CR vs non on CR? Shall we distinguish CR with sunitinib alone from combined CR (sunitinib with local treatment), while in clinical report these 2 cohorts present similar time to recurrence (ALBIGES, ASCO 2010)? Can we identify potential predictive serum biomarkers of recurrence? (With the aim of isolating blood biomarker that can help on treatment discontinuation decision?) 
Sponsor: Pfizer 
Intervention: sunitinib 
Start Date: 2015-05-21 
Last Updated: 2023-11-13 
Number of Patients: 77 
Recruitment Status: COMPLETED 
Condition: Complete Remission in Renal Cell Carcinoma 

NCTID: NCT01732926

Title: Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas 
Study Summary: The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).  An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). 
Sponsor: Gilead Sciences 
Intervention: Idelalisib 
Start Date: 2013-01-02 
Last Updated: 2018-11-16 
Number of Patients: 475 
Recruitment Status: TERMINATED 
Condition: Indolent Non-Hodgkin’s Lymphomas 

NCTID: NCT03123393

Title: TAK-659 in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) 
Study Summary: The purpose of this study is to assess the efficacy of TAK-659 measured by independent radiologic review committee (IRC)-assessed overall response rate (ORR) in participants with relapsed or refractory DLBCL. 
Sponsor: Calithera Biosciences, Inc 
Intervention: TAK-659 
Start Date: 2017-10-10 
Last Updated: 2023-02-08 
Number of Patients: 49 
Recruitment Status: TERMINATED 
Condition: Diffuse Large B-cell Lymphoma 

NCTID: NCT04728893

Title: Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003) 
Study Summary: The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter’s transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström’s macroglobulinemia (WM). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Nemtabrutinib 
Start Date: 2021-04-05 
Last Updated: 2023-11-24 
Number of Patients: 450 
Recruitment Status: RECRUITING 
Condition: Hematologic Malignancies 

NCTID: NCT03410693

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

NCTID: NCT01905163

Title: Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients 
Study Summary: This prospective nonrandomized multicenter phase II study, will evaluate the possibility of performing a laparoscopic interval debulking after a minimum of 3 cycles of chemotherapy in highly chemo-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal. 
Sponsor: Centre Jean Perrin 
Intervention: Tumor Debulking Surgery by laparoscopy 
Start Date: 2013-08 
Last Updated: 2017-07-19 
Number of Patients: 47 
Recruitment Status: COMPLETED 
Condition: Ovarian Cancer 

NCTID: NCT02627963

Title: A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC) 
Study Summary: This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC).  Participants will be randomized (1:1) to treatment with tivozanib or sorafenib.  Participants will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor <math display="block">programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor</math> plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent).  All participants will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability.  Pharmacokinetic (PK) analyses are also included in study. 
Sponsor: AVEO Pharmaceuticals, Inc. 
Intervention: Tivozanib hydrochloride 
Start Date: 2016-05-24 
Last Updated: 2023-07-18 
Number of Patients: 350 
Recruitment Status: COMPLETED 
Condition: Carcinoma, Renal Cell 

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: NCT02869516

Title: Institut Paoli Calmettes Acute Leukemia Database 
Study Summary: Database of Institut Paoli-Calmettes patients diagnosed with Acute Leukemia 
Sponsor: Institut Paoli-Calmettes 
Intervention: Clinical data collection 
Start Date: 1995-01 
Last Updated: 2016-08-17 
Number of Patients: 27000 
Recruitment Status: RECRUITING 
Condition: Acute Leukemia Diagnosis 

NCTID: NCT01976182

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

NCTID: NCT03669445

Title: Study Association of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab in Newly Diagnosed Standard Risk Multiple Myeloma 
Study Summary: The main objective of this study is to evaluate the minimal residual disease-negativity rate after administration of the combination of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab as induction and consolidation therapy in an intensive program in newly diagnosed standard risk multiple myeloma patients.  For the induction therapy, each patient received 6 cycles of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab, then peripheral blood stem cell harvest, intensification with autologous stem cell transplantation, consolidation therapy and maintenance. 
Sponsor: University Hospital, Toulouse 
Intervention: Ixazomib 
Start Date: 2018-12-31 
Last Updated: 2020-07-30 
Number of Patients: 45 
Recruitment Status: RECRUITING 
Condition: Multiple Myeloma 

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: NCT02034916

Title: A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study) 
Study Summary: The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:  * Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or * Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease 
Sponsor: Pfizer 
Intervention: talazoparib 
Start Date: 2013-12-13 
Last Updated: 2019-10-14 
Number of Patients: 84 
Recruitment Status: TERMINATED 
Condition: Breast Neoplasms 

NCTID: NCT04113616

Title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML) 
Study Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, when administered alone and in combination with low-dose cytarabine (LDAC) or Decitabine for the treatment of adults with Acute Myeloid Leukemia (AML) and AML secondary to myeloproliferative neoplasms (MPN). Participants must be relapsed/refractory (having failed prior therapy) and will be assigned to receive monotherapy (KRT-232 alone) or combination therapy (KRT-232 with LDAC or KRT-232 with Decitabine). 
Sponsor: Kartos Therapeutics, Inc. 
Intervention: KRT-232 
Start Date: 2019-09-25 
Last Updated: 2023-08-02 
Number of Patients: 86 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Relapsed or Refractory Acute Myeloid Leukemia (AML) 

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: NCT03667417

Title: Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation 
Study Summary: Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers 
Sponsor: Institut Paoli-Calmettes 
Intervention: Questionnaires 
Start Date: 1999-10-15 
Last Updated: 2020-07-01 
Number of Patients: 5000 
Recruitment Status: RECRUITING 
Condition: Breast Cancers 

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: NCT02860793

Title: Role of PTK-7 in Acute Myeloid Leukemias 
Study Summary: The pseudo tyrosine kinase receptor 7 (PTK7) is an orphan tyrosine kinase receptor assigned to the planar cell polarity pathway. PTK7 is expressed in normal myeloid progenitors and CD34(+) CD38(-) bone marrow cells in humans. It is also expressed in acute myeloid leukemia (AML) and is mostly assigned to granulocytic lineage differentiation. In AML, PTK7 seems to convey promigratory and antiapoptotic signals into the cell and represents an independent prognosis factor of survival in patients treated with induction chemotherapy. This study aims at:  * evaluating the impact of PTK7 expression on primary AML cells ex vivo * evaluating the diagnostic and prognostic value of a soluble form of PTK7 
Sponsor: Institut Paoli-Calmettes 
Intervention: Bone marrow aspiration 
Start Date: 2014-01 
Last Updated: 2016-08-10 
Number of Patients: 10 
Recruitment Status: COMPLETED 
Condition: Acute Myeloid Leukemia 

NCTID: NCT02869620

Title: Institut Paoli Calmettes Thyroid Cancer Database 
Study Summary: Database of Institut Paoli-Calmettes patients diagnosed with thyroid cancer 
Sponsor: Institut Paoli-Calmettes 
Intervention: Data collection 
Start Date: 2010-01 
Last Updated: 2016-08-17 
Number of Patients: 3000 
Recruitment Status: RECRUITING 
Condition: Thyroid Neoplasms 

NCTID: NCT03834506

Title: Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921) 
Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).  There are two primary study hypotheses.  Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS).  Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone 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: 2019-05-02 
Last Updated: 2023-08-25 
Number of Patients: 1030 
Recruitment Status: COMPLETED 
Condition: Prostatic Neoplasms 

NCTID: NCT03275506

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

NCTID: NCT03518606

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

NCTID: NCT05204927

Title: 177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer
Study Summary: A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer. 
Sponsor: Curium US LLC 
Intervention: 177Lu-PSMA-I&T 
Start Date: 2022-02-14 
Last Updated: 2023-11-28 
Number of Patients: 400 
Recruitment Status: RECRUITING 
Condition: Metastasis From Malignant Tumor of Prostate 

NCTID: NCT02662309

Title: Preoperative MPDL3280A in Transitional Cell Carcinoma of the Bladder 
Study Summary: ABACUS is an open-label, international, multi-centre, window of opportunity phase II trial for patients with histologically confirmed (T2-T4a) transitional cell carcinoma of the bladder. The trial aims to test the efficacy of preoperative MPDL3280A and will include extensive biomarker work on samples from these patients. Eligible patients will receive two 3-weekly cycles of MPDL3280A pre-cystectomy. Following cystectomy, patients will be followed up for safety, survival, and disease data. 
Sponsor: Queen Mary University of London 
Intervention: MPDL3280A 
Start Date: 2016-02 
Last Updated: 2020-02-25 
Number of Patients: 96 
Recruitment Status: UNKNOWN 
Condition: Bladder 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: NCT00003852

Title: Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow patients to tolerate higher doses of chemotherapy and kill more tumor cells.  PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have germ cell tumors that have not responded to previous chemotherapy. 
Sponsor: UNICANCER 
Intervention: filgrastim 
Start Date: 1998-03 
Last Updated: 2016-06-23 
Number of Patients: 45 
Recruitment Status: TERMINATED 
Condition: Childhood Germ Cell Tumor 

NCTID: NCT04464226

Title: Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer 
Study Summary: The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor’s visits as often as they did in the previous study. 
Sponsor: Bayer 
Intervention: Darolutamide (Nubeqa, BAY1841788) 
Start Date: 2020-10-20 
Last Updated: 2023-11-18 
Number of Patients: 678 
Recruitment Status: RECRUITING 
Condition: Cancer 

NCTID: NCT04023526

Title: A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy 
Study Summary: The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy. 
Sponsor: OncoVerity, Inc. 
Intervention: Azacitidine 
Start Date: 2019-07-29 
Last Updated: 2023-08-09 
Number of Patients: 103 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Leukemia, Myeloid, Acute 

NCTID: NCT05463263

Title: A Phase 1/2 Study of STP938 for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas 
Study Summary: The Phase 1 part of the study is a dose escalation of STP938 as monotherapy.  The Phase 2 part of the study is cohort expansion of STP938 as a monotherapy in 5 different B and T cell lymphomas. 
Sponsor: Step Pharma, SAS 
Intervention: STP938 
Start Date: 2022-08-03 
Last Updated: 2023-09-21 
Number of Patients: 180 
Recruitment Status: RECRUITING 
Condition: Lymphoma, B-Cell 

NCTID: NCT02841293

Title: Cost-utility of Two Strategies of Perineal Reconstruction After Abdominoperineal Resection for Anorectal Carcinoma 
Study Summary: Abdominoperineal resection performed for anorectal tumors leaves a large pelvic and perineal defect causing a high rate of morbidity of the perineal wound (40 - 60 %). Biological meshes offer possibility for a new standard of perineal wound reconstruction. Perineal filling with biological mesh is expected to increase quality of life by reducing perineal morbidity. 
Sponsor: University Hospital, Toulouse 
Intervention: Biological mesh 
Start Date: 2021-02-07 
Last Updated: 2021-03-04 
Number of Patients: 140 
Recruitment Status: RECRUITING 
Condition: Abdominoperineal Resection 

NCTID: NCT02856893

Title: Osimertinib Treatment on EGFR T790M Plasma Positive NSCLC Patients (APPLE) 
Study Summary: The phase II APPLE trial gives the opportunity to prospectively validate liquid biopsies as a new standard for testing tumor progression compared with conventional radiological procedure in EGFR mutant advanced NSCLC patients. Moreover based on the sequential T790M test during treatment the investigators will assess the predictive value of liquid biopsies. APPLE trial will examine the best strategy for delivering osimertinib (upfront versus sequential treatment after 1st generation EGFR TKI) in EGFR mutant NSCLC patients. Finally, the trial will also explore the mechanisms of acquired resistance to Osimertinib based on the results of an optional biopsy upon progression. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: Osimertinib 
Start Date: 2017-10-10 
Last Updated: 2022-09-15 
Number of Patients: 156 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: NSCLC 

NCTID: NCT05378204

Title: Study Evaluating DNA Double-strand Breaks (DSBs) REpair Factors (POLQ, Shieldin Complex and 53BP1) Expression as Biomarker of PARP Inhibitor Resistance in Patients With Deleterious Germline Mutation in BRCA 1/2 and HER2-negative, Metastatic or Locally Advanced Breast Cancer. 
Study Summary: The purpose of this study is to assess whether expression of not only POLQ/Polθ, but also Shieldin complex and/or 53BP1 are correlated with primary and/or acquired resistance to PARPi (Poly(ADP-Ribose) Polymerases inhibitors) in a sub-population of locally advanced or metastatic breast cancer patients and vary regarding type and location of gBRCA1/2 mutations.  This translational research program is composed of two multicentric, non-randomized prospective studies in patients with HER2-negative locally advanced or metastatic breast cancer:  * The main study concerns 80 patients eligible for PARPi (according to the investigators).PARPi treatments (talazoparib or olaparib) will be administered and dosed according to the standard of care administration. * The sub-study concerns 40 patients in progression disease under PARPi alone.  For each included patient in the main study or sub-study, tumor biopsy specimen and blood samples will be collected at different times during the study. 
Sponsor: Institut Claudius Regaud 
Intervention: Main study: 
Start Date: 2022-06-23 
Last Updated: 2023-07-13 
Number of Patients: 120 
Recruitment Status: RECRUITING 
Condition: Breast Cancer 

NCTID: NCT04015804

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

NCTID: NCT04675827

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

NCTID: NCT02545504

Title: Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma 
Study Summary: The primary objective of this study is to compare the efficacy of andecaliximab (GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival. 
Sponsor: Gilead Sciences 
Intervention: Andecaliximab 
Start Date: 2015-10-13 
Last Updated: 2020-05-26 
Number of Patients: 432 
Recruitment Status: COMPLETED 
Condition: Gastric Adenocarcinoma 

NCTID: NCT01712217

Title: A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib 
Study Summary: The purpose of the study is to evaluate safety and efficacy of AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer. 
Sponsor: Astex Pharmaceuticals, Inc. 
Intervention: AT13387 
Start Date: 2012-10 
Last Updated: 2018-01-19 
Number of Patients: 220 
Recruitment Status: COMPLETED 
Condition: Non-small Cell Lung Cancer(NSCLC) 

NCTID: NCT03428217

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

NCTID: NCT02375204

Title: Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors 
Study Summary: This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors. 
Sponsor: Alliance for Clinical Trials in Oncology 
Intervention: paclitaxel 
Start Date: 2015-08-05 
Last Updated: 2023-08-31 
Number of Patients: 420 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Germ Cell Tumor 

NCTID: NCT03186326

Title: Standard Chemotherapy vs Immunotherapie in 2nd Line Treatment of MSI Colorectal Mestastatic Cancer 
Study Summary: Immune chekpoints (ICI) are evaluated in many digestive cancers. Certain types of cancer appear to be rather refractory to ICI such as colorectal cancers (CRC). However, the MSI CRC representing approximately 15% of the CRCs exhibits a high mutational load which generates many potentially immunogenic neoantigens. In addition, strong expression of PD-L1 was found in the MSI CRCs relative to the CRC (MSS) stages. Localized MSI CRCs have a better prognosis than MSS CRCs, probably due to immunogenic neoantigens associated with a CD8 + T-specific immune response. On the oher hand, in metastatic CRC (mCRC) things are different because i) the MSI frequency is only 4 to 7% and ii) the good prognosis conferred by the MSI status is controversial.  Preliminary results suggest that patients with MSI mCRC are highly sensitive to ICI even chemoresistant tumors receiving several lines of chemotherapy. Recently, another anti-PD1 alone or in combination with an anti-CTLA4 (antigen associated with cytotoxic T-lymphocyte 4) was tested in the MSI CRCs and a selection of interesting results in heavily pretreated patients with a disease control rate of 56% for monotherapy and 81% for combinated therapy.  Anti-PD1s now have marketing authorization for patients with melanoma and metastatic pulmonary carcinoma , Which are known to have a high level of mutations . ICIs appear to be as promising in MSI CRCs as in other tumors and therefore face the same major challenges.  Avalumab is an anti-PD-L1 antibody recently tested in several different types of tumors with promising results and is currently being studied in phase III in gastric cancer. There is no data on the effectiveness of this ICI in the MSI mCRCs. In addition, only anti-PD1 was used in the MSI-mCRC and not the anti-PD-L1, and only in chemoresistance (3rd line or more). The main objective of the SAMCO study is to test the efficacy and tolerance of avelumab in the 2nd line of treatment in patients with a MSI mCRC progression after standard 1st line chemotherapy +/- targeted therapy. 
Sponsor: Federation Francophone de Cancerologie Digestive 
Intervention: FOLFOX regimen 
Start Date: 2018-04-24 
Last Updated: 2022-08-19 
Number of Patients: 132 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Colorectal Cancer 

NCTID: NCT03371017

Title: A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer 
Study Summary: This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC). 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2018-01-11 
Last Updated: 2023-11-07 
Number of Patients: 572 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Triple Negative Breast Neoplasms 

NCTID: NCT03221426

Title: Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585) 
Study Summary: The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.  The primary study hypotheses are that:  * Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and * Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2017-10-09 
Last Updated: 2023-09-22 
Number of Patients: 1007 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Gastric Cancer 

NCTID: NCT00894049

Title: A Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation 
Study Summary: This study is a prospective comparison between 2 popular regimens based on reduced intensity or non-myeloablative approaches to define the optimal myeloablative and/or immu-nonsuppressive association for reduced intensity conditionings (RIC).  Flu-Bu-ATG (Study A) associated Fludarabine (30mg/m²/5 days), Oral Busulfan (8 mg/kg over 2 days) and Thymoglobuline (2.5 mg/m²/1day).  Flu-TBI (Study B) consisted of Fludarabine (25mg/m²/ 3 days) and 2 Gy total body irradiation (TBI).  A randomization of 2 phase study according to the methodology developed by Liu et al (Liu, 1993 and 2001) for the evaluation of multiple innovative approaches.  Primary endpoint is one year overall survival (OS). Stopping rules included excessive engraftment failure and trans-plant related mortality ratio. Data are yearly reviewed by an independent safety review board (ISRB).  Inclusion criteria are patients presenting a hematological malignancy, eligible for non myeloablative allo stem cell transplantation (SCT), aged between 18 and 65, with a suitable HLA identical sibling. All patients and donors are included after giving written informed consent.  Protocol was submitted and accepted by the ethical committee and the AFFSSAPS cellular therapies committee (national agency). 
Sponsor: Institut Paoli-Calmettes 
Intervention: reduced intensity conditionings 
Start Date: 2002-11 
Last Updated: 2014-01-01 
Number of Patients: 148 
Recruitment Status: COMPLETED 
Condition: Allograft 

NCTID: NCT03842982

Title: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI) 
Study Summary: This is a phase III, multicenter, interventional and randomized study which evaluates the use of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) coupled with either Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS), in patients with ovarian cancer. This study aims to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC combined with standard care (PDS or IDS) or standard care alone. 
Sponsor: Centre Oscar Lambret 
Intervention: HIPEC 
Start Date: 2019-04-01 
Last Updated: 2022-12-07 
Number of Patients: 362 
Recruitment Status: RECRUITING 
Condition: Ovary Neoplasms 

NCTID: NCT04659382

Title: Study to Evaluate Efficacy and Safety of Selective Internal Radiation Therapy Plus Xelox, Bevacizumab and Atezolizumab (Immune Chekpoint Inhibitor) in Patients With Liver-dominant Metastatic Colorectal Cancer 
Study Summary: The main objective of the SIRTCI study is to evaluate the safety and efficacy of the combination chemotherapy (XELOX: Capecitabine plus oxaliplatin), anti-angiogenic (Bevacizumab), SIRT (TheraSphere®) and ICI (Atezolizumab) in patients with CRC with predominant liver metastases. SIRTCI is a single-arm, prospective, multi-centre phase II study. The main inclusion criteria are patients with MSS mRCC with predominantly non-operable liver metastases and measurable disease. Patients with extra-hepatic metastases can be included since the objective of the study is to induce local and abscopal effects of radiotherapy combined with ICI by stimulating the anti-tumour immune response to destroy both hepatic and extra-hepatic metastases. 
Sponsor: Federation Francophone de Cancerologie Digestive 
Intervention: Atezolizumab 
Start Date: 2020-10-07 
Last Updated: 2023-08-18 
Number of Patients: 52 
Recruitment Status: RECRUITING 
Condition: Metastatic Colorectal Cancer 

NCTID: NCT02266420

Title: Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm 
Study Summary: This is a prospective, non-randomized and multicenter study designed to compare biological features between pN0 triple negative breast cancer (TNBC) with size ≤ 10 mm (pT1a/b) versus pT1c T2 ≤ 30 mm.  All consecutive patients will be recruited by each investigator after completion of surgery. No modification of standard management according to each investigator center will be done. All patients will then be followed each year during 5 years in order to collect the following events: local and loco regional recurrence, metastatasis, second cancer, death or not and the cause.  At initial visit, a 10 mL blood sample will be collected (= study intervention) and immediately processed for serum storage; all serum samples will be stored at -80°C and may be used for the purpose of further scientific research.  A representative formalin-fixed paraffin-embedded tumor block of all 200 samples will be addressed at the Institut Claudius Regaud for central collection which will consist of one haematoxylin-eosin stained slide for central histological review, up to 15 unstained slides for DNA extraction (after microdissection), and construction of a tissue micro-array (TMA).  Extracted DNA from 100 samples (50 in each group) will then be transferred to Institut Paoli Calmettes, Marseille; extracted DNA will be subjected to array-CGH analysis in order to detect gene copy number alterations such as gains/amplifications/deletions, and to next generation sequencing (NGS; MiSeq, Illumina) using a panel of ~400 genes for mutation detection. 
Sponsor: Institut Claudius Regaud 
Intervention: Blood samples of 10 mL 
Start Date: 2014-10-23 
Last Updated: 2023-08-03 
Number of Patients: 151 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mm 

NCTID: NCT03961893

Title: Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas 
Study Summary: Colonoscopy is the gold standard for colorectal cancer prevention by allowing the resection of superficial colorectal adenomas or adenocarcinomas. This protection, more effective in the left colon than in the right colon, is imperfect and there are some adenomas and cancers omitted during colonoscopy. The G-EYE colonoscope equipped with an integrated distal balloon would better unfold the haustrations and stabilize the endoscope. Thus, the detection rate of adenomas would be improved by this better vision. The main objective of this study is to confirm that the use of the G-EYE colonoscope allows better detection of adenomatous polyps, decrease the rate of omitted adenomes and then is more effective. 
Sponsor: Institut Paoli-Calmettes 
Intervention: G-EYE first and standard colonoscope 
Start Date: 2020-01-21 
Last Updated: 2023-06-23 
Number of Patients: 164 
Recruitment Status: COMPLETED 
Condition: Colorectal Adenoma 

NCTID: NCT01810393

Title: A Study to Assess Preference for Subcutaneous Trastuzumab Treatment in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Trastuzumab for at Least 3 Years 
Study Summary: This open-label, randomized, multicenter study will evaluate participant preference for subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with HER2-positive metastatic breast cancer responding to first-line treatment with IV trastuzumab for at least 3 years. Participants will be randomized to receive either 3 cycles (cycle length = 21 days) of trastuzumab SC followed by 3 cycles of trastuzumab IV or 3 cycles of trastuzumab IV followed by 3 cycles of trastuzumab SC. All participants will receive trastuzumab SC for Cycles 7 to 18. Anticipated time on study treatment is 1 year or until disease progression or inacceptable toxicity occurs, whichever comes first. 
Sponsor: Hoffmann-La Roche 
Intervention: Trastuzumab 
Start Date: 2013-06-11 
Last Updated: 2020-09-04 
Number of Patients: 114 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT01434420

Title: Triple Negative Breast Cancer: Study of Molecular and Genetic Factors 
Study Summary: Breast cancer triples negatives (TN; 15 % of the cases) are characterized by a high histoprognostic grade, a strong proliferation, a strong metastatic power, and a worse prognosis than the other forms of breast cancer. It is however a heterogenous group for histological and molecular level, but also for evolution. Most of the TN is part of the basal breast cancer subcategory. Until now, the medical treatment is based on chemotherapy.  Breast cancers by constitutional mutation of BRCA1 / BRCA2 (5 % of breast cancers) are mostly of basal type and their prognostic seems better that what could be expected from high grade tumours and without hormonal receptors. They would be much more frequent in the TN group. However, at this day, no prospective study was led to estimate this incidence, or to study the intervention of other genes of predisposition, as well to analyse the links between this phenotype and their consequences at the germinal or somatic level, in terms of associated molecular changes and prognosis.  The purpose of this study is, on a prospective study, to lead a joined analysis at the germinal level, in search of mutations of the main genes of breast cancer predisposition (BRCA1/2, PALB2, PTEN, PALB2), and at the tumour level (tissue micro-array and transcriptome), by correlating these results to the main clinical parameters.  The 5 years relapse-free survival will also be estimated. 
Sponsor: Institut Paoli-Calmettes 
Intervention: BRCA1 BRCA2 PTEN PALB2 mutation 
Start Date: 2011-03 
Last Updated: 2014-12-31 
Number of Patients: 200 
Recruitment Status: UNKNOWN 
Condition: Breast Cancer 

NCTID: NCT00885508

Title: A Study of the Efficacy and Safety of Lenalidomide Combined to Escalating Doses of Chemotherapy in Intermediate-2-or High Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) With Del 5q 
Study Summary: In this trial, the investigators will test the combination of escalating doses of chemotherapy (starting at relatively low dose) with lenalidomide in intermediate-2-or high risk MDS and AML with del 5 q31. It is hoped that this combined therapy will further increase response rate in intermediate-2-or high risk MDS and AML with del 5 q31, without major toxicity in comparison to historical results obtained with chemotherapy alone in the same subset of patients. 
Sponsor: Groupe Francophone des Myelodysplasies 
Intervention: Lenalidomide 
Start Date: 2009-02 
Last Updated: 2015-04-24 
Number of Patients: 85 
Recruitment Status: UNKNOWN 
Condition: Myelodysplastic Syndrome 

NCTID: NCT00910091

Title: The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer 
Study Summary: This trial will explore the safety and efficacy of BN83485 compared to Megestrol Acetate (MA) on progression free survival (PFS) in post menopausal patients with endometrial cancer. 
Sponsor: Ipsen 
Intervention: BN83495 
Start Date: 2009-08 
Last Updated: 2019-01-30 
Number of Patients: 73 
Recruitment Status: COMPLETED 
Condition: Endometrial Cancer 

NCTID: NCT03503409

Title: IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic Syndrome 
Study Summary: patients with MDS (Myelodysplastic Syndrome) and mutated IDH1 patients will be treated with AG120 (IDH1 inhibitor) 
Sponsor: Groupe Francophone des Myelodysplasies 
Intervention: AG-120 
Start Date: 2019-05-14 
Last Updated: 2023-01-04 
Number of Patients: 68 
Recruitment Status: RECRUITING 
Condition: Myelodysplastic Syndromes 

NCTID: NCT05826509

Title: SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer 
Study Summary: This is a phase II, multicenter, randomized open-label and comparative trial designed to study the effectiveness and the safety of androgen receptor antagonist (darolutamide) combined with surgery in patients with high-risk and/or locally advanced prostate cancer.  In this trial, patients will be assigned in one of the two following treatments arms:  * Arm A (control arm): Surgery alone (radical prostatectomy with lymph node dissection) * Arm B (experimental arm): Peri-operative darolutamide + surgery (radical prostatectomy with lymph node dissection)  A total of 240 patients will have to be randomized with 120 patients in the control arm and 120 patients in the experimental arm. 
Sponsor: Institut Claudius Regaud 
Intervention: Surgery alone 
Start Date: 2023-08-10 
Last Updated: 2023-11-27 
Number of Patients: 240 
Recruitment Status: RECRUITING 
Condition: Prostate Cancer 

NCTID: NCT04789408

Title: Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia 
Study Summary: The goal of this clinical study is to learn more about the safety and dosing of the study drug, KITE-222, in participants with relapsed/refractory (r/r) acute myeloid leukemia (AML). 
Sponsor: Kite, A Gilead Company 
Intervention: Cyclophosphamide 
Start Date: 2021-07-19 
Last Updated: 2023-11-08 
Number of Patients: 40 
Recruitment Status: RECRUITING 
Condition: Acute Myeloid Leukemia 

NCTID: NCT00541008

Title: Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer 
Study Summary: RATIONALE: Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.  PURPOSE: This phase II trial is studying how well sunitinib works as first-line therapy in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer. 
Sponsor: UNICANCER 
Intervention: sunitinib malate 
Start Date: 2007-09-05 
Last Updated: 2021-02-21 
Number of Patients: 92 
Recruitment Status: COMPLETED 
Condition: Kidney Cancer 

NCTID: NCT00820508

Title: Safety and Tolerability of CHR-2845 to Treat Haematological Diseases or Lymphoid Malignancies 
Study Summary: The purpose of this study is to determine whether the histone deacetylase inhibitor CHR-2845 is tolerated in patients with haematological diseases and lymphoid malignancies. 
Sponsor: Chroma Therapeutics 
Intervention: CHR-2845 
Start Date: 2008-12 
Last Updated: 2011-11-28 
Number of Patients: 18 
Recruitment Status: COMPLETED 
Condition: Hematological Disease 

NCTID: NCT01506609

Title: Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer 
Study Summary: The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer. 
Sponsor: AbbVie 
Intervention: Placebo 
Start Date: 2012-01-23 
Last Updated: 2021-10-25 
Number of Patients: 294 
Recruitment Status: COMPLETED 
Condition: Metastatic Breast Cancer 

NCTID: NCT02966691

Title: Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors 
Study Summary: This clinical study is designed to evaluate the diagnostic performance of VisioCyt test, which would improve the early diagnosis of bladder cancer in order to optimize the management of individual patients as part of a cancer diagnostic monitoring. The diagnostic method of VisioCyt® device is based on the analysis by transmission and fluorescence, of urinary cytology slides prepared according to the protocol VisioCyt. 
Sponsor: Vitadx 
Intervention: VisioCyt® diagnostic test 
Start Date: 2017-01-24 
Last Updated: 2022-01-06 
Number of Patients: 1360 
Recruitment Status: COMPLETED 
Condition: Bladder Cancer 

NCTID: NCT05781308

Title: Combination of Paclitaxel-bevacizumab ± Atezolizumab in Patients With Advanced NSCLC Progressing After Immunotherapy & Chemotherapy 
Study Summary: This is an open-label, randomized, non-comparative, multicentre, phase II study in which NSCLC patients who have progressed following chemotherapy and immunoptherapy are randomized to receive treatment with either paclitaxel and bevacizumab (Arm A), or paclitaxel, bevacizumab and atezolizumab (Arm B). An estimated 156 patients (52 in Arm A, 104 in Arm B) will be enrolled at approximately 40 centres. Patients will be treated until disease progression, unacceptable toxicity, withdrawal of consent or another discontinuation criterion is met. For patients in Arm B, continuation of atezolizumab beyond progression is permitted, at the investigator’s discretion, if there is evidence of continued clinical benefit. The null hypothesis is progression free survival at 6 months ≤ 50% for Arm B, which is considered not sufficiently clinically meaningful to warrant further study. The alternative hypothesis is that 66% or more of patients in Arm B would achieve progression free survival at 6 months. 
Sponsor: Intergroupe Francophone de Cancerologie Thoracique 
Intervention: Paclitaxel 
Start Date: 2023-04-26 
Last Updated: 2023-05-01 
Number of Patients: 156 
Recruitment Status: RECRUITING 
Condition: Non Small Cell Lung Cancer 

NCTID: NCT02623309

Title: Studyof Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor in Elderly Patients 
Study Summary: Allogeneic (Allo) hematopoietic stem cell transplantation (HSCT) is a recognized curative procedure for hematological malignancies. It is now well known that this property is related to the graft-versus-tumor (GVT) effect developed from the immunocompetent cells contained in or generating from the donor graft. For years, however, and despite this unique antitumoral activity, Allo-HSCT has been restricted to a limited number of patients due to two major limitations: the toxicity of the procedure and the absence of a donor for every single patients. More recently the stage has dramatically changed with respect to these two restraints. Over the last decade, many studies have established the feasibility of Allo-HSCT in older patients but the availability of MRD is even less frequent in elderlies, likely related to medical contraindication for graft donation or sibling deaths. UD are routinely used but associated with a high incidence of GVHD. As compared to younger populations, unrelated cord-blood HSCT is seldom performed in this population and numbers decrease with age due to the feared risk of supposed increased lethal infectious complications related to the effect of the delayed immune reconstitution in elderlies. Thus the need for alternative donors allowing for a safe and efficient transplantation is still unmet. In consequence, overall, despite the fact that Allo-HSCT feasibility has been established in the oldest patients, all these lacks contribute eventually to maintain a low rate of allo-HSCT performed in a population with the higher incidence of hematologic malignancies that usually present with the poorest prognosis.  Thus it is critical developing innovative efficient therapeutic strategies answering this unmet-medical need. In this perspective, Haplo-HSCT could represent a part of the answer in this aged population. It offers the potential advantage to offer a rapid donor determination for virtually every single patient. In addition, our data suggest that in elderlies haplo-HSCT using T-repleted graft, RIC and PT-HDCy presents low NRM and retains an antitumor effect despite low GVHD incidences. They also suggest that haplo-HSCT may conduct to better outcome than URD-HSCT as an alternative to MRD-HSCT. It may also be associated with lower costs (no graft purchase and low post-transplant complications rate) and better QOL likely related to low cGVHD-rate. In addition the conduct of such trial at a time when the diffusion of the strategy in this population is just starting is really crucial before widespread uncontrolled dissemination.  The investigators propose to address this question by prospectively comparing these 2 strategies in elderly patients without MRD, in terms of efficacy, safety and including the prospective evaluation study of quality-of-life (QOL). They will conduct a national, multicenter, open-label, comparative, randomized phase III trial in patients with hematological malignancies justifying an allo-HSCT from an alternative donor when a MRD has not been identified.  When MRD search is recognized to be a failure, patients will be included in the clinical trial after informed consent and randomized in the two strategies based on donor search:  * Reference group: Unrelated Donor group * Investigational group: Haplo Donor Group  Investigators will use a composite end-point embracing the three main causes of failure: death, relapse and severe cGVHD (as a surrogate endpoint for QOL). We will analyze the HSCT usual objectives as GHVD, NRM, relapse and survival. A specific study of patients’ health related quality of life will also be conducted using the FACT-BMT questionnaire. In addition, the success of the two strategies in term of transplant completion (donor determination, transplant realization and time to do so) will be compared. 
Sponsor: Institut Paoli-Calmettes 
Intervention: Allogeneic (Allo) hematopoietic stem cell transplantation 
Start Date: 2016-02-23 
Last Updated: 2023-01-31 
Number of Patients: 108 
Recruitment Status: COMPLETED 
Condition: Hematologic Neoplasms 

NCTID: NCT01168791

Title: Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma 
Study Summary: This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS). 
Sponsor: Alaunos Therapeutics 
Intervention: doxorubicin in combination with palifosfamide-tris 
Start Date: 2010-07 
Last Updated: 2013-07-18 
Number of Patients: 447 
Recruitment Status: COMPLETED 
Condition: Soft Tissue Sarcoma 

NCTID: NCT02292979

Title: Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma. 
Study Summary: This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography ) after two cycles of chemotherapy. 
Sponsor: The Lymphoma Academic Research Organisation 
Intervention: Doxorubicin 
Start Date: 2015-03 
Last Updated: 2022-08-19 
Number of Patients: 170 
Recruitment Status: COMPLETED 
Condition: Hodgkin Lymphoma 

NCTID: NCT00227708

Title: Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in older patients.  PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients with locally advanced or metastatic non-small cell lung cancer. 
Sponsor: UNICANCER 
Intervention: docetaxel 
Start Date: 2005-06 
Last Updated: 2020-02-13 
Number of Patients: 58 
Recruitment Status: COMPLETED 
Condition: Lung Cancer 

NCTID: NCT01773408

Title: A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia 
Study Summary: This Phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of escalating doses of RO5503781 as a single agent or in combination with cytarabine in participants with acute myelogenous leukemia. In Part 1, RO5503781 will be administered in escalating doses as a single agent, and in Part 2, RO5503781 will be administered in combination with cytarabine. An optional Part 3 in which RO5503781 will be administered with cytarabine and anthracycline may be considered . In Part 4, the safety and pharmacokinetic profile of an optimized formulation of RO5503781 in combination with cytarabine will be assessed. 
Sponsor: Hoffmann-La Roche 
Intervention: RO5503781 MBP 
Start Date: 2013-02 
Last Updated: 2017-01-25 
Number of Patients: 122 
Recruitment Status: COMPLETED 
Condition: Myelogenous Leukemia, Acute 

NCTID: NCT03052608

Title: A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC 
Study Summary: A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population 
Sponsor: Pfizer 
Intervention: Lorlatinib 
Start Date: 2017-04-27 
Last Updated: 2023-06-07 
Number of Patients: 296 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Carcinoma, Non-Small-Cell Lung 

NCTID: NCT00055679

Title: Combination Chemotherapy in Treating Women With Stage I Breast Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early breast cancer.  PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of combination chemotherapy in treating women who have stage I breast cancer. 
Sponsor: UNICANCER 
Intervention: cyclophosphamide 
Start Date: 2002-08 
Last Updated: 2013-06-18 
Number of Patients: 1512 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT01147939

Title: Study of Elacytarabine Versus Investigator’s Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML) 
Study Summary: The purpose of the study is to assess the efficacy and safety of elacytarabine versus investigator’s choice treatment in patients with relapsed or refractory acute myeloid leukemia (AML). 
Sponsor: Clavis Pharma 
Intervention: Elacytarabine 
Start Date: 2010-06 
Last Updated: 2013-09-27 
Number of Patients: 381 
Recruitment Status: COMPLETED 
Condition: Acute Myeloid Leukemia (AML) 

NCTID: NCT03185039

Title: Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents 
Study Summary: Prospective research of Matrix Metalloproteinases (MMP) 2 and 9 as predictive biomarkers in metastatic kidney cancer patients treated with 2 anti angiogenic agents (Sunitinib or Pazopanib). 
Sponsor: Institut Paoli-Calmettes 
Intervention: Blood and tumor samples 
Start Date: 2017-05-29 
Last Updated: 2020-01-10 
Number of Patients: 50 
Recruitment Status: UNKNOWN 
Condition: Kidney Cancer 

NCTID: NCT00005979

Title: Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer.  PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III colon cancer. 
Sponsor: UNICANCER 
Intervention: FOLFIRI regimen 
Start Date: 1998-07-22 
Last Updated: 2021-02-17 
Number of Patients: NA 
Recruitment Status: COMPLETED 
Condition: Colorectal Cancer 

NCTID: NCT02485379

Title: Assessment of Prostate MRI Before Prostate Biopsies 
Study Summary: Background: Prostate cancer is difficult to detect using ultrasound. As a result, in case of suspicion of prostate cancer based on digital rectal examination (DRE) or Prostate Specific Antigen (PSA) level, it is currently recommended to perform “blinded” systematically distributed biopsies with 10-18 samples obtained from predefined locations in the gland.  These so-called systematic biopsies (SB) may lead to improper patient management by (i) missing clinically significant cancer, especially in the anterior half of the gland that tends to be undersampled, (ii) inducing chance detection of clinically insignificant cancer foci that may result in overtreatments, (iii) undersampling the tumor foci and thus underestimating their volume and aggressiveness.  Multiparametric Magnetic Resonance Imaging (mp-MRI) has yielded promising results in detecting aggressive (Gleason ≥7) prostate cancers. Several monocenter studies showed that targeted biopsies (TB) based on mp-MRI findings could detect significantly more aggressive cancers, reduce the diagnosis of clinically insignificant cancers, and better evaluate the aggressiveness of detected cancers than SB. However, these monocenter studies only provide low-level evidence and three recent independent reviews of literature concluded that there was a need for a robust multicenter trial evaluating the diagnostic yield of TB as compared to SB. This is particularly important since many academic and private centers in France already perform mp-MRI before prostate biopsy in daily routine. Therefore the risk is that this approach becomes the norm without being properly evaluated and it is crucial and urgent to perform a controlled multicentric study to provide high-level evidence as to whether mp-MRI should or should not be obtained before prostate biopsy.  One controlled multicentric study has been published recently in which SB and TB had been obtained by two different operators in 95 patients. TB yielded a significantly higher detection rate for all prostate cancers (69% vs 59%, p=0.033) and for clinically significant cancers (67% vs 52%, p=0.0011). However, this study was limited by the fact that patients with negative mp-MRI were not included.  Research hypotheses: There is currently no robust multicenter trial comparing prostate TB based on mp-MRI findings versus the current standard of care (SB). We propose a multicentre prospective trial comparing the results of SB and TB performed in the same patients by two independent operators. Our hypothesis is that TB detects aggressive (Gleason ≥7) cancers in a significantly higher percentage of patients than SB.  Main objective: To compare the percentage of patients with “clinically significant cancer” (using definition A, i.e. cancer with Gleason score ≥7) detected by SB versus TB. 
Sponsor: Hospices Civils de Lyon 
Intervention: Prostate biopsy 
Start Date: 2015-07 
Last Updated: 2017-07-24 
Number of Patients: 275 
Recruitment Status: COMPLETED 
Condition: Prostate Cancer 

NCTID: NCT03441139

Title: Efficacy of Cryotherapy Combined or Not With Analgesics in Uncontrolled Painful Musculoskeletal Metastasis 
Study Summary: The primary objective of this trial is to compare the efficacy of 2 analgesic strategies, based on percutaneous cryotherapy plus medical supportive care versus medical supportive care alone in the treatment of cancer patients with painful musculoskeletal metastasis. 
Sponsor: Centre Leon Berard 
Intervention: Cryotherapy + Medical analgesics 
Start Date: 2018-07-19 
Last Updated: 2021-10-19 
Number of Patients: 18 
Recruitment Status: TERMINATED 
Condition: Musculoskeletal Pain 

NCTID: NCT05986071

Title: I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers 
Study Summary: CDK4/6 inhibitor in combination with endocrine treatment is the standard of care in advanced breast cancer (ABC) with expression of hormone receptors and without HER2 overexpression (ER+/HER2-). When patients experience disease progression under this strategy, options of second-line endocrine treatment in combination with other targeted therapies are limited and have failed to improve overall survival to date over endocrine treatment alone. A significant fraction of ER+/HER2- ABC display genetic alterations associated with homologous recombination deficiency (HRD) which may be associated with efficacy of therapeutic targeting DNA damage response (DDR) pathways. Moreover, other molecular alterations associated with replicative stress may be found in ER+/HER2- ABC patients which may also favor antitumor activity of DDR targeting therapeutics. M1774 is a novel orally administered inhibitor of ataxia telangiectasia and rad3-related (ATR), a protein kinase with key activity in DDR pathway. MATRIx is a phase I/II study aiming to determine the recommended phase II dose (RP2D, phase I) as well as efficacy and safety (phase II) of M1774 in combination with fulvestrant in ER+/HER2-ABC patients whose disease has become resistant to aromatase inhibitor plus CDK4/6 inhibitor, and whose tumor displays molecular alterations associated with HRD, oncogenic driver activation and/or replicative stress. Primary endpoints will include: maximum tolerated dose (MTD) of M1774 in combination with fulvestrant (phase I), the clinical benefit rate and toxicity of the combination at RP2D of M1774 in the molecularly selected population (phase II). Baseline, on-treatment and post-treatment blood and tumor tissue samples will be collected for pharmacokinetics and translational analyses including genomic characterization of tumor tissue and ctDNA as well as functional studies focusing on DDR pathways. 
Sponsor: Institut Paoli-Calmettes 
Intervention: M1774 
Start Date: 2024-04-01 
Last Updated: 2023-08-14 
Number of Patients: 57 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT00978471

Title: Adjuvant High-Dose Thiotepa and Stem Cell Rescue Associated With Conventional Chemotherapy in Relapsed Osteosarcoma 
Study Summary: Approximately 150 new cases of osteosarcoma are reported each year in France, of which 15 to 20% are metastatic.  Further to the initial standard care, about 45% of the patients relapse within a median duration of 20 months.  Result of the OS94 study results and of the investigation performed within the CRLCC, indicate that 25 to 30 patients (children and adults) experience an osteosarcoma relapse each year in FRANCE.  According to several studies, the 5-year overall survival rate of patients in first relapse is 23-28%,with a median post relapse survival of 10 to 17 months. Multiple relapse cases are also reported in the COSS study, with a median time to second relapse of 0.8 year.  At present, there is no reference treatment for the standard care of osteosarcoma relapse in FRANCE.  Thiotepa is known for its antitumor effect in numerous malignant tumors. In 2007, a study from our institution reported that about 35% of all osteosarcoma relapses are treated with a high-dose thiotepa while the efficacy and tolerance of this therapeutic strategy have never been assessed.  These results highlight the need to the evaluate the efficacy and tolerance of this high-dose of thiotepa within a clinical trial and its inclusion in the standard care of the osteosarcoma at relapse. 
Sponsor: Centre Leon Berard 
Intervention: Thiotepa 
Start Date: 2009-07 
Last Updated: 2019-05-17 
Number of Patients: 44 
Recruitment Status: COMPLETED 
Condition: Osteosarcoma 

NCTID: NCT01718379

Title: Lenalidomide in Subject With Low and Intermediate-1 Risk MDS and Without Chromosome 5 Abnormality. 
Study Summary: The goal of the present study is to assess, through a randomized phase II trial, the efficacy and safety of Lenalidomide with or without Epoetin beta in transfusion-dependent, ESA-resistant, IPSS low and intermediate-1 risk MDS patients without chromosome 5 abnormality.  Patients will receive either Lenalidomide alone or Lenalidomide and Epoetin beta for 4 months. Responders will be eligible for maintenance treatment with cycles identical to the first cycles, until relapse occurs or until unacceptable toxicity. 
Sponsor: Groupe Francophone des Myelodysplasies 
Intervention: Lenalidomide 
Start Date: 2010-07 
Last Updated: 2016-11-08 
Number of Patients: 132 
Recruitment Status: COMPLETED 
Condition: Myelodysplastic Syndromes 

NCTID: NCT00766779

Title: HCT Versus CT in Elderly AML 
Study Summary: A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission. 
Sponsor: European Society for Blood and Marrow Transplantation 
Intervention: hematopoietic cell transplantation 
Start Date: 2010-01 
Last Updated: 2021-10-14 
Number of Patients: 126 
Recruitment Status: TERMINATED 
Condition: Acute Myeloid Leukemia 

NCTID: NCT05168839

Title: Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage 
Study Summary: Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer in the world and the third in France. Its incidence is steadily rising in developing nations. Anastomotic leak (AL) is a major problem in colorectal surgery affecting at least 7% of patients operated on for left colonic cancer. It is the most feared complication after colorectal anastomosis, associated with mortality, prolonged hospitalization, impaired health related quality of life (HRQoL) and increased health care costs. Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG) may help preventing AL. Available studies on the effects of IOFA with ICG are heterogeneous and randomized controlled trial are scarce. Our aim is to demonstrate that IOFA with ICG could lead to a reduction of AL rate after left-sided or low anterior resection with anastomosis for CRC.  The FLUOCOL-1 study is the first national, multicenter, single blind, randomized, 2-arm, phase III superiority clinical trial. The primary endpoint is the occurrence of an AL 90 days post-operation. AL is defined as any anastomotic dehiscence with leakage into the pelvic cavity diagnosed upon imaging or at surgical exploration or any isolated pelvic organ-space infection with no evidence of fistula as defined by the International Study Group of Rectal Cancer.  The study population will be made of adult patients with left-sided or high rectal cancer scheduled to undergo elective left colectomy or high rectal resection (by open, laparoscopy or robotic surgery) and with expected stapled or hand-sewn intraperitoneal anastomosis. The exclusion criteria are mainly an emergent surgery; rectal cancer requiring total mesorectal excision and anastomosis expected below the peritoneal reflection; CRC requiring total or subtotal colectomy; CRC requiring transverse colectomy; recurrent CRC and locally advanced colorectal cancer requiring multi-visceral excision.  A total of 1010 patients will be necessary (39 patients in each centre during 36 months). An interim analysis for efficacy and futility is scheduled when half of the participants will have been recruited.  In case of positive results favoring IOFA, this study would define the use of IOFA as a standard of care in colorectal surgery. At the patient level, a significantly lower rate of AL will reduce hospital stay and stoma rate, and will ensure improved postoperative recovery, faster return to normal activity and better long-term oncologic outcomes. 
Sponsor: Centre Hospitalier Universitaire de Besancon 
Intervention: FLUO+ : Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG). 
Start Date: 2022-09-26 
Last Updated: 2023-04-06 
Number of Patients: 1010 
Recruitment Status: RECRUITING 
Condition: Colorectal Cancer 

NCTID: NCT01485679

Title: 18 Fluoro-deoxy-glucose Positrons Emission Tomography Combined With Computed Tomography (18-FDG TEP-CT ) in the Diagnosis of the Degeneration of Intraductal Papillary Mucinous Tumor of the Pancreas 
Study Summary: The aim of the study is to evaluate whether the TEP-CT can be sensitive and specific in identifying degenerated intraductal papillary mucinous tumor of the pancreas.The results will be compared to those obtained by the pathological analysis of the removed piece of pancreas. 
Sponsor: Nantes University Hospital 
Intervention: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography 
Start Date: 2011-01 
Last Updated: 2016-05-18 
Number of Patients: 126 
Recruitment Status: COMPLETED 
Condition: Tumor 

NCTID: NCT00195871

Title: Safety and Efficacy of an Adult Acute Lymphoblastic Leukemia Chemotherapy for Adult Lymphoblastic Lymphoma 
Study Summary: The primary objective of this study is to evaluate the safety and the efficacy of an adult “acute lymphoblastic leukaemia” type chemotherapy in patients less than 60 years with lymphoblastic lymphoma. Treatment principle is based on an intensive induction and a delayed intensification. 
Sponsor: Centre Henri Becquerel 
Intervention: Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide 
Start Date: 2004-02 
Last Updated: 2013-11-07 
Number of Patients: 155 
Recruitment Status: UNKNOWN 
Condition: Lymphoblastic Lymphoma 

NCTID: NCT03906071

Title: Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Study Summary: This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy. 
Sponsor: Mirati Therapeutics Inc. 
Intervention: Nivolumab 
Start Date: 2019-07-15 
Last Updated: 2023-10-24 
Number of Patients: 532 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Non-Squamous Non-Small Cell Lung Cancer 

NCTID: NCT01702571

Title: A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
Study Summary: This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants. 
Sponsor: Hoffmann-La Roche 
Intervention: Trastuzumab Emtansine 
Start Date: 2012-11-27 
Last Updated: 2022-04-04 
Number of Patients: 2185 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT04620239

Title: ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study 
Study Summary: This is a phase 3, open label, single arm study of padeliporfin in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade non-invasive upper tract urothelial carcinoma in either the kidney or the ureter. Patients will be treated with padeliporfin VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase and will be followed up for up to an additional 48 months in the long term (non intervention) follow up phase with the specific duration depending on the patient’s response to treatment 
Sponsor: Steba Biotech S.A. 
Intervention: padeliporfin VTP 
Start Date: 2021-03-22 
Last Updated: 2023-07-18 
Number of Patients: 100 
Recruitment Status: RECRUITING 
Condition: Transitional Cell Cancer of Renal Pelvis and Ureter 

NCTID: NCT03331068

Title: French Validation of the Memorial Anxiety Scale for Patients With Prostate Cancer. 
Study Summary: A specific scale allowing the measure of anxiety of patients with protate cancer has been designed and validated but the French version needs to be validated. This study aims at validating the French translation of this scale. 
Sponsor: Institut Paoli-Calmettes 
Intervention: online questionnaire of MAX-PC 
Start Date: 2016-04-26 
Last Updated: 2017-11-07 
Number of Patients: 180 
Recruitment Status: COMPLETED 
Condition: Prostate Cancer 

NCTID: NCT04069468

Title: Non-Interventional Registry Study to Evaluate the Effectiveness of TheraSphere® in the Treatment of Hepatocellular Carcinoma (HCC) 
Study Summary: The purpose of this registry study is to gather effectiveness, QoL, safety and procedural information on TheraSphere® for the treatment of participants with Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (iCC) and liver metastases for colon cancer (mCRC) in real world clinical practice settings in France. 
Sponsor: Boston Scientific Corporation 
Intervention: TheraSphere 
Start Date: 2019-03-13 
Last Updated: 2023-11-18 
Number of Patients: 500 
Recruitment Status: RECRUITING 
Condition: Hepatocellular Carcinoma 

NCTID: NCT04934475

Title: MInimal Residual Disease Adapted Strategy 
Study Summary: IFM 2020-02 will enroll patients eligible for ASCT less than 66 years. All patients will receive induction based on 6 cycles (28-day) of KRD-Isatuximab (Isa-KRD), in order to achieve deep responses and high MRD negativity rates. Patients will be classified at diagnosis according to cytogenetics (standard vs high-risk cytogenetics defined by the LP score including 17p deletion, t(4;14), del(1p32), gain 1q, trisomy 21 and trisomy 5). 
Sponsor: Intergroupe Francophone du Myelome 
Intervention: Isatuximab 
Start Date: 2021-12-08 
Last Updated: 2023-02-28 
Number of Patients: 716 
Recruitment Status: RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT04992949

Title: Evaluation of CPX-351 Monotherapy in Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasm 
Study Summary: The three classic myeloproliferative neoplasms (MPNs) include polycythemia Vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF). The natural history of these MPNs is the possible progression to acute myeloid leukemia (MPN-blast phase) at variable percentage depending the entity. Leukemic transformation of MPN occurs in 8% to 23% of primary myelofibrosis (PMF) patients in the first 10 years after diagnosis and in 4% to 8% of polycythemia vera (PV) and essential thrombocytosis (ET) patients within 18 years after diagnosis. The risk for leukemic transformation is increased by exposure to cytotoxic chemotherapy. The molecular pathogenesis of MPN-blast phase remains an area of active research.  The prognosis of blast phase MPNs is very poor : approximately 50% of the patients are deemed eligible for intensive treatment (ie. conventional induction chemotherapy regimen with anthracyclines and cytarabine). The patients who are not fit for such intensive treatment approach due to age or comorbidities, are treated with Hypomethylating agents, low dose palliative chemotherapy, or supportive care. Nevertheless, there is a need for more effective and better tolerated treatment approaches in order to increase the response rate and hence, the transplant rates which should translate into improved survival.  CPX-351 is a new formulation of cytarabine and daunorubicin encapsulated at a fixed 5:1 molar-ratio in liposomes that exploits molar ratio-dependent drug-drug synergy to enhance antileukemic efficacy.  Based on similarities between post-myelodysplastic syndrome (MDS) and post-MPN secondary AML in terms of disease resistance to chemotherapy, of fragile patient profile, The hypotheses made is that CPX-351 may improve the results of induction chemotherapy without increasing its toxicity and therefore may increase the proportion of patients who could benefit from an allogeneic Stem Cell Transplantation (SCT). 
Sponsor: French Innovative Leukemia Organisation 
Intervention: CPX-351 
Start Date: 2022-03-23 
Last Updated: 2022-10-18 
Number of Patients: 42 
Recruitment Status: RECRUITING 
Condition: Acute Myeloid Leukemia 

NCTID: NCT03637868

Title: Eribulin in Brain Metastases From HER2-negative Breast Cancer 
Study Summary: To evaluate the efficacy of eribulin for treatment of HER2-negative breast cancer brain metastases (BCBM) 
Sponsor: Institut Paoli-Calmettes 
Intervention: Eribulin 
Start Date: 2019-02-26 
Last Updated: 2020-05-06 
Number of Patients: 0 
Recruitment Status: WITHDRAWN 
Condition: Metastatic Breast Cancer 

NCTID: NCT03463668

Title: Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years 
Study Summary: To assess the efficacy of duodenal prostheses for duodenal stenosis established for endoscopic pyloric or duodenal stenosis on dysphagia 
Sponsor: Institut Paoli-Calmettes 
Intervention: uncovered metal duodenal prosthesis 
Start Date: 2017-12-22 
Last Updated: 2018-03-13 
Number of Patients: 200 
Recruitment Status: RECRUITING 
Condition: Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis 

NCTID: NCT01466868

Title: Study of MK 2206 in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma 
Study Summary: The purpose of this study is to evaluate the antitumor efficacy and the safety of MK 2206 in patients with relapsed or refractory diffuse large B cell lymphoma. 
Sponsor: Centre Leon Berard 
Intervention: MK2206 
Start Date: 2011-11 
Last Updated: 2014-07-10 
Number of Patients: 22 
Recruitment Status: TERMINATED 
Condition: Diffuse Large B Cell Lymphoma 

NCTID: NCT02869568

Title: Institut Paoli Calmettes Ovarian Cancer Database 
Study Summary: Database of Institut Paoli-Calmettes patients diagnosed with ovarian cancer 
Sponsor: Institut Paoli-Calmettes 
Intervention: Data collection 
Start Date: 2000-01 
Last Updated: 2016-08-17 
Number of Patients: 6000 
Recruitment Status: RECRUITING 
Condition: Ovarian Neoplasms 

NCTID: NCT01945775

Title: A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) 
Study Summary: The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician’s choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations. 
Sponsor: Pfizer 
Intervention: talazoparib 
Start Date: 2013-10-14 
Last Updated: 2022-01-20 
Number of Patients: 431 
Recruitment Status: COMPLETED 
Condition: Breast Neoplasms 

NCTID: NCT02311959

Title: Therapeutic Nipple Sparing Mastectomy. 
Study Summary: This is a phase III, multicentric, single arm study with a sequential design using the exact conditional Poisson test.  The primary objective of this prospective study is to evaluate whether selected breast carcinoma patients could be treated with nipple sparing mastectomy (NSM) with an acceptable low local recurrence rates.  450 patients will be included over a period of 4 years and will be followed for a 5 years period (twice a year).  All patients must have a complete preoperative evaluation (bilateral mammography, bilateral breast ultrasonography +/- MRI), and a histopathological diagnostic proof of carcinoma (invasive or in situ, all histopathological types, first treatment or relapse).  The study procedure is represented by nipple areola skin-sparing mastectomy followed by immediate breast reconstruction.  After surgery, early and late complications, including specific complications (suffering of the nipple-areolar complexe and suffering of the skin flaps), will be evaluate.  An esthetic evaluation (by patient and clinician) and a quality of life evaluation will be realized throughout the study.  A complementary study, prospective, non-interventional, will be proposed to patients who will benefit from the same surgical technique (NSM) followed by immediate reconstruction, but in the context of preventive surgery (prophylactic surgery for patients mutated or high genetic risk). The aim of this complementary study, which will include a maximum of 60 patients, is to evaluate associated morbidity in prophylactic NSM.  Data will be collected over a 3 months period after surgery. 
Sponsor: Institut Claudius Regaud 
Intervention: Nipple sparing mastectomy 
Start Date: 2015-02-09 
Last Updated: 2023-08-03 
Number of Patients: 450 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT02960906

Title: A BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer 
Study Summary: Disease and Stage: naïve metastatic kidney cancer.  A multicenter, randomized, a Phase 2 BIOmarker driven trial with Nivolumab and Ipilimumab or VEGFR tKi in naïve metastatic Kidney cancer 
Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie 
Intervention: Nivolumab 
Start Date: 2017-05-31 
Last Updated: 2021-04-26 
Number of Patients: 200 
Recruitment Status: COMPLETED 
Condition: Clear Cell Metastatic Renal Cell Carcinoma 

NCTID: NCT04778397

Title: Study of Magrolimab in Combination With Azacitidine Versus Physician’s Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated 
Study Summary: The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML). 
Sponsor: Gilead Sciences 
Intervention: Magrolimab 
Start Date: 2021-07-01 
Last Updated: 2023-10-11 
Number of Patients: 346 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Acute Myeloid Leukemia 

NCTID: NCT00849667

Title: Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse
Study Summary: This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer. 
Sponsor: Morphotek 
Intervention: Farletuzumab 
Start Date: 2009-04-16 
Last Updated: 2022-12-30 
Number of Patients: 1100 
Recruitment Status: TERMINATED 
Condition: Ovarian Cancer 

NCTID: NCT05963997

Title: A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer 
Study Summary: This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer. 
Sponsor: Carrick Therapeutics Limited 
Intervention: Samuraciclib 
Start Date: 2023-10-09 
Last Updated: 2023-10-23 
Number of Patients: 48 
Recruitment Status: RECRUITING 
Condition: Metastatic Breast Cancer 

NCTID: NCT03744390

Title: IDH2 (AG 221) Inhibitor in Patients With IDH2 Mutated Myelodysplastic Syndrome 
Study Summary: patients with MDS (Myelodysplastic Syndrome) and mutated IDH2 patients will be treated with AG221 (IDH2 inhibitor) 
Sponsor: Groupe Francophone des Myelodysplasies 
Intervention: AG-221 
Start Date: 2019-04-02 
Last Updated: 2023-01-04 
Number of Patients: 68 
Recruitment Status: RECRUITING 
Condition: Myelodysplastic Syndromes 

NCTID: NCT02173990

Title: Aflibercept and Chemotherapy as First Line Treatment for Metastatic Colorectal Cancer Assessable With DCE-US (PULSAR). 
Study Summary: The PULSAR trial is an international, investigator-initiated, single arm open-label phase II study. The aim of this study is to measure the clinical activity of the combination FOLFIRI-aflibercept in an homogeneous group of patients with metastatic colorectal cancer, and treated with a FOLFIRI-aflibercept regimen as first line treatment. 
Sponsor: Centre Oscar Lambret 
Intervention: Aflibercept-FOLFIRI 
Start Date: 2014-07 
Last Updated: 2021-10-20 
Number of Patients: 40 
Recruitment Status: TERMINATED 
Condition: Metastatic Colorectal Cancer 

NCTID: NCT04570943

Title: Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer 
Study Summary: The aim of this study is to demonstrate the efficacy of intensified and sequential chemotherapy (Gabrinox) comprising Gembrax regimen (Gemcitabine-Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) in patients with locally advanced pancreatic adenocarcinoma.  The study will also demonstrate the feasibility of combining this intensified chemotherapy with MRI-guided stereotactic radiotherapy in

hasTrialTitle::Safety and Efficacy of Ponatinib Followed by Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase hasTrialTitle::Radiation Therapy and Docetaxel With Either Fluorouracil or Cisplatin as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery hasTrialTitle::Axitinib +/- Pembrolizumab in First Line Treatment of mPRCC hasTrialTitle::Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer hasTrialTitle::Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma hasTrialTitle::A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma hasTrialTitle::SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients hasTrialTitle::A Study to Determine the Efficacy of Lenalidomide Versus Investigator’s Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) hasTrialTitle::A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203) hasTrialTitle::Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disorders hasTrialTitle::Axillary Sentinel Lymph Node Detection in Breast Cancers; 2 cm hasTrialTitle::Trastuzumab With or Without Everolimus in Treating Women With Breast Cancer That Can Be Removed By Surgery hasTrialTitle::Molecular Profiling of Advanced Soft-tissue Sarcomas hasTrialTitle::OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC hasTrialTitle::Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas hasTrialTitle::Economic Evaluation of the Use of Plerixafor for Autologous HSC Transplantation for Multiple Myeloma hasTrialTitle::Partial Nephrectomy in Low Pressure hasTrialTitle::Study of a Humanized Antibody Initiated 2 Months After an HLA Matched Allogenic Stem Cell Transplantation hasTrialTitle::Effect of Intratumoral Injection of Gene Therapy for Locally Advanced Pancreatic Cancer hasTrialTitle::Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer (NK)-T-cell Lymphoma hasTrialTitle::A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma hasTrialTitle::Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery hasTrialTitle::Evaluate Efficacy, Morbidity and Functional Outcome of Endoscopic TranAnal Proctectomy vs Standard Transabdominal Laparoscopic Proctectomy for Rectal Cancer hasTrialTitle::Evaluation of Efficacy and Safety of Nilotinib in Combination With Chemotherapy in Elderly Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia hasTrialTitle::Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients hasTrialTitle::A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) hasTrialTitle::Evaluation of Oesogastroduodenoscopy With Vision to 245 ° (Full Spectrum Endoscopy) to View the Main Disc and Accessory hasTrialTitle::Institut Paoli Calmettes Breast Cancer Database hasTrialTitle::Predictive Factors for Failure or Success of Endoscopic Treatment of Superficial Colorectal Tumors hasTrialTitle::A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis) hasTrialTitle::Multiorgan Metabolic Imaging Response Assessment of Abemaciclib hasTrialTitle::Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma hasTrialTitle::Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer hasTrialTitle::Efficacy and Safety of L19TNF in Previously Treated Patients With Advanced Stage or Metastatic Soft-tissue Sarcoma hasTrialTitle::A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL hasTrialTitle::National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis (ALTITUDES) hasTrialTitle::Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI) for Breast Cancer hasTrialTitle::Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old hasTrialTitle::A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma hasTrialTitle::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 hasTrialTitle::COaching and Prehabilitation: Faisability Study in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome hasTrialTitle::Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib hasTrialTitle::Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases hasTrialTitle::Biological Effect of Nab-paclitaxel Combined to Gemcitabine in Metastatic Pancreatic Cancer hasTrialTitle::Nintedanib (Vargatef®) Plus Docetaxel in Second Line of Treatment in Patients With Lung Cancer hasTrialTitle::European Stop Tyrosine Kinase Inhibitor Study hasTrialTitle::Extension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen hasTrialTitle::Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer hasTrialTitle::EXPRESS: EXcePtional RESponSe - Exceptional and Unexpected Response to Targeted Therapies hasTrialTitle::Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer hasTrialTitle::A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR hasTrialTitle::Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826) hasTrialTitle::Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer hasTrialTitle::Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer hasTrialTitle::Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated With Targeted Therapy hasTrialTitle::A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study hasTrialTitle::Standard Treatment +/- SBRT in Solid Tumors Patients With Between 1 and 3 Bone-only Metastases hasTrialTitle::Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients hasTrialTitle::NEoadjuvant Dose-dense MVAC In cOmbination With Durvalumab and Tremelimumab in Muscle-invasive Urothelial Carcinoma hasTrialTitle::Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer hasTrialTitle::Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver hasTrialTitle::Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015) hasTrialTitle::Fludarabine, Busulfan, and Antilymphocyte Globulin Followed by Donor Stem Cell Transplant in Treating Older Patients With Hematological Cancer hasTrialTitle::Ibrutinib With Rituximab in Adults With Waldenström’s Macroglobulinemia hasTrialTitle::MGMT-NET: O6-methylguanine-DNA Methyltransferase (MGMT) Status in Neuroendocrine Tumors: Predictive Factor of Response to Alkylating Agents hasTrialTitle::Safety of Ibritumomab Tiuxetan (Zevalin®) in Combination With a Fludarabine-based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007) hasTrialTitle::Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma hasTrialTitle::Sutent Rechallenge In mRCC Patients hasTrialTitle::Institut Paoli Calmettes Colorectal Cancer Database hasTrialTitle::Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia hasTrialTitle::Doxorubicin and Cyclophosphamide in Treating Older Women With Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery hasTrialTitle::A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL) hasTrialTitle::Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors hasTrialTitle::Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q) hasTrialTitle::Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy (M-RIC) hasTrialTitle::A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies hasTrialTitle::Vorinostat and Low Dose Cytarabine for High Risk Myelodysplasia hasTrialTitle::Cost Utility of Radical Surgery in Ovarian Cancer hasTrialTitle::Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor hasTrialTitle::Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer hasTrialTitle::Venetoclax + Cytarabine Versus Idarubicin + Cytarabine : Efficacity Assessment as Post-remission Therapy to Elderly Patients With Acute Myeloid Leukemia in First Remission hasTrialTitle::Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia hasTrialTitle::Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia hasTrialTitle::Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid hasTrialTitle::Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy hasTrialTitle::Rituximab, Fludarabine, and Cyclophosphamide or Observation Alone in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia hasTrialTitle::A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) hasTrialTitle::Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma hasTrialTitle::Institut Paoli Calmettes Cervical Cancer Database hasTrialTitle::GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer hasTrialTitle::Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System hasTrialTitle::A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies hasTrialTitle::Therapeutic Drug Monitoring of Sunitinib and Pazopanib in Advanced or Metastatic Renal Cell Carcinoma hasTrialTitle::BST-236 as a Single Agent in Adults With Relapsed or Refractory AML or HR-MDS hasTrialTitle::Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment hasTrialTitle::Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010) hasTrialTitle::A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy hasTrialTitle::Paclitaxel/Pazopanib for Platinum Resistant/Refractory Ovarian Cancer hasTrialTitle::Number of Weekly Steps, Fatigue, Quality of Life, Well-being During Cancer Treatment: Impact of Recommendations Strengthened by the Provision of Web Interface and Tele-coaching hasTrialTitle::Revlimid Dose 25 mg in Association With (R-CHOP) in the Treatment Follicular Lymphoma hasTrialTitle::A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types hasTrialTitle::Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015 hasTrialTitle::A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer hasTrialTitle::Endometrial Cancer Patientes MMR Deficient Comparing Chimiotherapy vs Dostarlimab in First Line hasTrialTitle::Evaluate the Clinical Benefit of a Post-operative Treatment Associating Radiotherapy + Nivolumab + Ipilimumab Versus Radiotherapy + Capecitabine for Triple Negative Breast Cancer Patients With Residual Disease hasTrialTitle::Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer hasTrialTitle::Natural Killer Cells in Older Patients With Acute Myeloid Leukemia hasTrialTitle::Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia hasTrialTitle::A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors hasTrialTitle::A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors hasTrialTitle::Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer hasTrialTitle::Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH hasTrialTitle::Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) hasTrialTitle::Molecular Characterization of Acute Erythroid Leukemia (M6-AML) Using Targeted Next-generation Sequencing hasTrialTitle::Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference hasTrialTitle::Safety and Efficacy of Mitazalimab in Combination With Chemotherapy in Pancreatic Cancer Patients hasTrialTitle::I-MVAC +/- Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma Without H-Ras Nor K-Ras Mutations hasTrialTitle::Open-Label Extension and Safety Study of Talazoparib hasTrialTitle::A Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression hasTrialTitle::Gemcitabine With or Without Capecitabine and/or Radiation Therapy or Gemcitabine With or Without Erlotinib in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery hasTrialTitle::Institut Paoli Calmettes Multiple Myeloma Database hasTrialTitle::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 hasTrialTitle::Study of Natural Killer Cells in Patients With Metastatic Prostate Cancer: Relationship With Survival and Response Time to Castration hasTrialTitle::Compare Lenalidomide and Subcutaneous Daratumumab vs Lenalidomide and Dexamethasone in Frail Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy hasTrialTitle::Serum-Ascites Albumin Gradient Analysis in Cancer Patients in Palliative Care hasTrialTitle::Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer hasTrialTitle::Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas hasTrialTitle::Controlled Study of Rigosertib Versus Physician’s Choice of Treatment in MDS Patients After Failure of an HMA hasTrialTitle::Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer hasTrialTitle::Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT hasTrialTitle::Efficiency of Imatinib Treatment Maintenance or Interruption After 3 Years of Adjuvant Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) hasTrialTitle::First-line Gemcitabine/Cisplatin +/- Avelumab in Locally Advanced or Metastatic Bladder Carcinoma hasTrialTitle::A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors hasTrialTitle::A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation hasTrialTitle::NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Randomized Patients in Two Arms With Soft Tissue Sarcoma of the Extremity and Trunk Wall hasTrialTitle::Fludarabine, Busulfan, Antithymocyte Globulin, and Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma That Has Not Responded to Treatment hasTrialTitle::Methylprednisolone With or Without Doxorubicin in Treating Patients With Metastatic Prostate Cancer hasTrialTitle::Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer hasTrialTitle::Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten) hasTrialTitle::A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) hasTrialTitle::Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes hasTrialTitle::QoL in mCRC Elderly Patients Receiving First-line Therapy Based on Simplified Geriatric Parameters hasTrialTitle::Safety and Efficacy of Revlimid® (Lenalidomide) With Mabthera® (Rituximab) in Non-Hodgkin’s Lymphoma hasTrialTitle::A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) hasTrialTitle::Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx hasTrialTitle::Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer hasTrialTitle::Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment hasTrialTitle::Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers hasTrialTitle::GRASPA Treatment for Patients With Acute Myeloblastic Leukemia hasTrialTitle::Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma hasTrialTitle::A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma hasTrialTitle::Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation hasTrialTitle::Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients hasTrialTitle::Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas hasTrialTitle::TAK-659 in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) hasTrialTitle::Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003) hasTrialTitle::Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma hasTrialTitle::Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients hasTrialTitle::A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC) hasTrialTitle::Durvalumab Maintenance After Thoracic Chemoradiotherapy in Frail Small Cell Lung Cancer Patients Whose Disease is Limited to the Thorax hasTrialTitle::Institut Paoli Calmettes Acute Leukemia Database hasTrialTitle::Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia hasTrialTitle::Study Association of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab in Newly Diagnosed Standard Risk Multiple Myeloma hasTrialTitle::ENCOrafenib With Binimetinib in bRAF NSCLC hasTrialTitle::A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study) hasTrialTitle::An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML) hasTrialTitle::Evaluation of Atezolizumab-Venetoclax-Obinutuzumab Combination in Relapse/Refractory Lymphomas hasTrialTitle::Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation hasTrialTitle::Assessment of the Impact of RNA Genomic Profile on Treatment Decision-making in HER2 Equivocal Breast Cancer Patients hasTrialTitle::Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia hasTrialTitle::A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function hasTrialTitle::Role of PTK-7 in Acute Myeloid Leukemias hasTrialTitle::Institut Paoli Calmettes Thyroid Cancer Database hasTrialTitle::Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921) hasTrialTitle::PEMBRO With Chemo in Neo Adj Treatment of Ovarian Cancer hasTrialTitle::Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours hasTrialTitle::177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer hasTrialTitle::Preoperative MPDL3280A in Transitional Cell Carcinoma of the Bladder hasTrialTitle::Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib hasTrialTitle::Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors hasTrialTitle::Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer hasTrialTitle::A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy hasTrialTitle::A Phase 1/2 Study of STP938 for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas hasTrialTitle::Cost-utility of Two Strategies of Perineal Reconstruction After Abdominoperineal Resection for Anorectal Carcinoma hasTrialTitle::Osimertinib Treatment on EGFR T790M Plasma Positive NSCLC Patients (APPLE) hasTrialTitle::Study Evaluating DNA Double-strand Breaks (DSBs) REpair Factors (POLQ, Shieldin Complex and 53BP1) Expression as Biomarker of PARP Inhibitor Resistance in Patients With Deleterious Germline Mutation in BRCA 1/2 and HER2-negative, Metastatic or Locally Advanced Breast Cancer hasTrialTitle::Robotic Low Rectum Anterior Resection hasTrialTitle::De-escalation Adjuvant Chemo in HER2+/ER-ode-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo & Dual HER2 Blockade hasTrialTitle::Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma hasTrialTitle::A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib hasTrialTitle::CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma hasTrialTitle::Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors hasTrialTitle::Standard Chemotherapy vs Immunotherapie in 2nd Line Treatment of MSI Colorectal Mestastatic Cancer hasTrialTitle::A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer hasTrialTitle::Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585) hasTrialTitle::A Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation hasTrialTitle::Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI) hasTrialTitle::Study to Evaluate Efficacy and Safety of Selective Internal Radiation Therapy Plus Xelox, Bevacizumab and Atezolizumab (Immune Chekpoint Inhibitor) in Patients With Liver-dominant Metastatic Colorectal Cancer hasTrialTitle::Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm hasTrialTitle::Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas hasTrialTitle::A Study to Assess Preference for Subcutaneous Trastuzumab Treatment in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Trastuzumab for at Least 3 Years hasTrialTitle::Triple Negative Breast Cancer: Study of Molecular and Genetic Factors hasTrialTitle::A Study of the Efficacy and Safety of Lenalidomide Combined to Escalating Doses of Chemotherapy in Intermediate-2-or High Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) With Del 5q hasTrialTitle::The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer hasTrialTitle::IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic Syndrome hasTrialTitle::SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer hasTrialTitle::Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia hasTrialTitle::Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer hasTrialTitle::Safety and Tolerability of CHR-2845 to Treat Haematological Diseases or Lymphoid Malignancies hasTrialTitle::Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer hasTrialTitle::Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors hasTrialTitle::Combination of Paclitaxel-bevacizumab ± Atezolizumab in Patients With Advanced NSCLC Progressing After Immunotherapy & Chemotherapy hasTrialTitle::Studyof Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor in Elderly Patients hasTrialTitle::Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma hasTrialTitle::Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma hasTrialTitle::Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer hasTrialTitle::A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia hasTrialTitle::A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC hasTrialTitle::Combination Chemotherapy in Treating Women With Stage I Breast Cancer hasTrialTitle::Study of Elacytarabine Versus Investigator’s Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML) hasTrialTitle::Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents hasTrialTitle::Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer hasTrialTitle::Assessment of Prostate MRI Before Prostate Biopsies hasTrialTitle::Efficacy of Cryotherapy Combined or Not With Analgesics in Uncontrolled Painful Musculoskeletal Metastasis hasTrialTitle::I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers hasTrialTitle::Adjuvant High-Dose Thiotepa and Stem Cell Rescue Associated With Conventional Chemotherapy in Relapsed Osteosarcoma hasTrialTitle::Lenalidomide in Subject With Low and Intermediate-1 Risk MDS and Without Chromosome 5 Abnormality hasTrialTitle::HCT Versus CT in Elderly AML hasTrialTitle::Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage hasTrialTitle::18 Fluoro-deoxy-glucose Positrons Emission Tomography Combined With Computed Tomography (18-FDG TEP-CT ) in the Diagnosis of the Degeneration of Intraductal Papillary Mucinous Tumor of the Pancreas hasTrialTitle::Safety and Efficacy of an Adult Acute Lymphoblastic Leukemia Chemotherapy for Adult Lymphoblastic Lymphoma hasTrialTitle::Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer hasTrialTitle::A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment hasTrialTitle::ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study hasTrialTitle::French Validation of the Memorial Anxiety Scale for Patients With Prostate Cancer hasTrialTitle::Non-Interventional Registry Study to Evaluate the Effectiveness of TheraSphere® in the Treatment of Hepatocellular Carcinoma (HCC) hasTrialTitle::MInimal Residual Disease Adapted Strategy hasTrialTitle::Evaluation of CPX-351 Monotherapy in Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasm hasTrialTitle::Eribulin in Brain Metastases From HER2-negative Breast Cancer hasTrialTitle::Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years hasTrialTitle::Study of MK 2206 in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma hasTrialTitle::Institut Paoli Calmettes Ovarian Cancer Database hasTrialTitle::A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) hasTrialTitle::Therapeutic Nipple Sparing Mastectomy hasTrialTitle::A BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer hasTrialTitle::Study of Magrolimab in Combination With Azacitidine Versus Physician’s Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated hasTrialTitle::Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse hasTrialTitle::A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer hasTrialTitle::IDH2 (AG 221) Inhibitor in Patients With IDH2 Mutated Myelodysplastic Syndrome hasTrialTitle::Aflibercept and Chemotherapy as First Line Treatment for Metastatic Colorectal Cancer Assessable With DCE-US (PULSAR) hasTrialTitle::Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer hasCancerType::C00-D48: All neoplasms hasCancerType::C00-C97: All cancer types hasCancerType::C00-C14: Mouth/throat cancers hasCancerType::C15-C26: Digestive system cancers hasCancerType::C30-C39: Lung/chest cancers hasCancerType::C40-C41: Bone cancers hasCancerType::C43-C44: Skin cancers/melanoma hasCancerType::C45-C49: Soft tissue cancer hasCancerType::C50: Breast cancer hasCancerType::C51-C58: Female genitalia cancers hasCancerType::C60-C63: Male genitalia cancer hasCancerType::C64-C68: Urinary system cancers hasCancerType::C69-C72: Eye and brain cancer hasCancerType::C73-C75: Thyroid and other gland cancers hasCancerType::C76-C80: Cancers of unknown or unspecified areas hasCancerType::C81-C96: Cancers of the blood and immune system hasCancerType::C97-C97: Cancers in multiple locations from the start hasCancerType::D00-D09: Early-stage cancers not yet spread hasCancerType::D10-D36: Benign tumour hasCancerType::D37-D48: Growths of uncertain nature hasCancerType::unknown isTrial