Trials (Eugène Marquis Cancer Centre)

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NCTID: NCT02444000

Title: gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas 
Study Summary: Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk of neurocognitive deterioration without impairing overall survival. 
Sponsor: Assistance Publique - Hôpitaux de Paris 
Intervention: PCV chemotherapy alone 
Start Date: 2015-09-22 
Last Updated: 2022-10-26 
Number of Patients: 280 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Anaplastic Gliomas With 1p/19q Codeletion 

NCTID: NCT04250922

Title: LAM561 With RT and TMZ for Adults With Glioblastoma 
Study Summary: The proposed Phase IIB/III randomized, double-blind, placebo-controlled trial in subjects with newly diagnosed primary glioblastoma multiforme (ndGBM) aims to compare the efficacy and safety of LAM561 versus placebo, given with standard of care (SoC) therapy of radiation therapy plus temozolomide (TMZ), followed by an adjuvant treatment of 6 month period of TMZ and then LAM561 or placebo in monotherapy. 
Sponsor: Laminar Pharmaceuticals 
Intervention: LAM561 
Start Date: 2019-12-01 
Last Updated: 2023-09-29 
Number of Patients: 140 
Recruitment Status: RECRUITING 
Condition: Primary Glioblastoma 

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: NCT04736485

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

NCTID: 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: NCT03427814

Title: Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer 
Study Summary: This study enrolled participants with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A participants received BGB-290; in Arm B participants received placebo. The purpose of this study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer. 
Sponsor: BeiGene 
Intervention: Pamiparib 
Start Date: 2018-07-03 
Last Updated: 2023-09-21 
Number of Patients: 136 
Recruitment Status: COMPLETED 
Condition: Advanced or Inoperable Gastric Cancer 

NCTID: NCT02500043

Title: Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer 
Study Summary: The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer. 
Sponsor: Taiho Oncology, Inc. 
Intervention: TAS-102 
Start Date: 2016-02-24 
Last Updated: 2021-09-16 
Number of Patients: 507 
Recruitment Status: COMPLETED 
Condition: Refractory Metastatic Gastric Cancer 

NCTID: NCT04459715

Title: A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX) 
Study Summary: The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). 
Sponsor: EMD Serono Research & Development Institute, Inc. 
Intervention: Xevinapant (Debio 1143) 
Start Date: 2020-08-07 
Last Updated: 2023-10-24 
Number of Patients: 730 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Squamous Cell Carcinoma of the Head and Neck 

NCTID: 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: NCT02271659

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

NCTID: 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: NCT04197986

Title: Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations 
Study Summary: This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer. 
Sponsor: QED Therapeutics, Inc. 
Intervention: Infigratinib 
Start Date: 2020-03-11 
Last Updated: 2023-02-02 
Number of Patients: 39 
Recruitment Status: TERMINATED 
Condition: Upper Tract Urothelial Carcinomas 

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: NCT02662725

Title: Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases 
Study Summary: This is a non-controlled, open label, Phase II Study of ipilimumab combined with a Stereotactic Radiosurgery. The study included an induction phase of four IV infusions of Ipilimumab at 10 mg/kg every 3 weeks associated with a stereotactic radiosurgery performed 3 days before 2nd ipilimumab administration. A Maintenance phase included Ipilimumab, IV, 10 mg/kg once every 12 weeks, starting at week 24, in the absence of PD, unacceptable toxicity or withdrawal of consent or disease progression. The primary objective is the overall survival. The Secondary objectives include safety, ORR, PFS and peripheral blood absolute lymphocyte count (ALC) as a predictive biomarker. 
Sponsor: University Hospital, Lille 
Intervention: IPILIMUMAB 
Start Date: 2012-09 
Last Updated: 2016-01-25 
Number of Patients: 73 
Recruitment Status: COMPLETED 
Condition: Melanoma 

NCTID: NCT02574455

Title: Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC) 
Study Summary: The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician’s choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline. 
Sponsor: Gilead Sciences 
Intervention: Sacituzumab govitecan 
Start Date: 2017-11-07 
Last Updated: 2022-06-15 
Number of Patients: 529 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT01166737

Title: Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer 
Study Summary: It is still not clear whether a positive AGO-score just selects patients with less aggressive biologic tumor behavior who as well would have had a positive outcome by chemotherapy only, or , if it is a score selecting patients who really benefit from surgery. Nevertheless, the AGO-score was confirmed to select patients with a less than 30% risk of ending with residual tumor after surgery for recurrent disease. This could avoid including patients into the present surgical protocol who could not benefit from an operationThe goal of this third DESKTOP study is to evaluate in a prospectively randomized multicentre setting, whether maximum effort of cytoreductive surgery followed by platinum based combination chemotherapy can improve overall survival as compared to platinum based combination chemotherapy alone in AGO-score positive patients. 
Sponsor: AGO Study Group 
Intervention: Tumor Debulking Surgery (surgery in recurrent ovarian disease) 
Start Date: 2010-07 
Last Updated: 2022-01-25 
Number of Patients: 408 
Recruitment Status: COMPLETED 
Condition: Fallopian Tube Cancer 

NCTID: NCT03643133

Title: Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients 
Study Summary: Trial evaluating the impact on efficacy of mifamurtide as add-on treatment to post-operative chemotherapy compared to post-operative chemotherapy alone in first-line treatment of patients with high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response). 
Sponsor: UNICANCER 
Intervention: Mifamurtide 
Start Date: 2018-10-23 
Last Updated: 2022-12-09 
Number of Patients: 126 
Recruitment Status: RECRUITING 
Condition: Osteosarcoma 

NCTID: 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: NCT05364905

Title: Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma 
Study Summary: This is a national observational retrospective multi-site chart review study of patients with advanced, recurrent or metastatic endometrial carcinoma. 
Sponsor: ARCAGY/ GINECO GROUP 
Intervention: Chemotherapy 
Start Date: 2022-05-09 
Last Updated: 2023-09-06 
Number of Patients: 200 
Recruitment Status: COMPLETED 
Condition: Oncology 

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: NCT05441163

Title: ProActIF-01 Trial: Randomized Study of Evaluation of an Individualized Program of Nutrition and Adapted Physical Activity in Frail Patients With Advanced Lung or Digestive Cancers 
Study Summary: The ProActIF-01 trial aims to assess the efficacy of a supervised 8-week combined APA and nutrition individualized program on survival without HRQoL deterioration (European Organization for Research and Treatment of Cancer-Quality of Life-C30 questionnaire, EORTC QLQ-C30, 1 targeted dimension), in advanced lung or digestive cancer patients. 
Sponsor: Institut Curie 
Intervention: APA and nutrition intervention 
Start Date: 2023-04-08 
Last Updated: 2023-04-24 
Number of Patients: 273 
Recruitment Status: RECRUITING 
Condition: CANCER 

NCTID: NCT03102320

Title: Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors 
Study Summary: The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors.  The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas.  Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule).  Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor’s objective response rate. Radiological tumor assessments will be performed at defined time points until the patient’s disease progresses.  Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses. 
Sponsor: Bayer 
Intervention: Cisplatin 
Start Date: 2017-05-26 
Last Updated: 2022-06-30 
Number of Patients: 173 
Recruitment Status: COMPLETED 
Condition: Neoplasms 

NCTID: NCT05265208

Title: Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer 
Study Summary: Treatment of intrahepatic cholangiocarcinoma (ICC) remains difficult. Many patients have unresectable tumors, and survival after resection was only slightly improved with the use of adjuvant capecitabine. One of the major prognostic factors is the resection margin, patients with invaded (R1) or narrow (<5mm) margins having a higher risk of recurrence.  Selective Internal Radiation Therapy (SIRT) with Yttrium-90 microspheres (also known as SIRT) is an interesting treatment in unresectable ICC. In a phase 2 study, the investigators showed a response rate of 39% and a disease control rate of 98%. Interestingly, 9 of the 41 patients were able to see their tumors downstages to surgery. It was also recently suggested in a retrospective study that patients resected after SIRT had a better prognosis than patients that could be operated upfront, despite less favorable initial tumor characteristics.  Given the absence of validated neoadjuvant treatment, the promising activity of SIRT and chemotherapy combination in the unresectable setting, and the prognostic significance of close surgical margins, the aim of this trial is therefore to study this combination treatment in the neoadjuvant setting of resectable ICC. 
Sponsor: Center Eugene Marquis 
Intervention: Capecitabine 
Start Date: 2022-02-04 
Last Updated: 2023-11-13 
Number of Patients: 62 
Recruitment Status: SUSPENDED 
Condition: Resectable Intrahepatic Cholangiocarcinoma 

NCTID: NCT04524871

Title: A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) 
Study Summary: This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer.  Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2020-11-02 
Last Updated: 2023-11-13 
Number of Patients: 400 
Recruitment Status: RECRUITING 
Condition: Advanced Liver Cancers 

NCTID: NCT02676349

Title: Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44) 
Study Summary: This is a prospective, randomized phase II trial. The aim of this study is to assess the efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or without preoperative chemoradiotherapy with capecitabine. 
Sponsor: Institut de Cancérologie de Lorraine 
Intervention: mFolfirinox 
Start Date: 2016-10-13 
Last Updated: 2023-09-28 
Number of Patients: 130 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Pancreatic Carcinoma 

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: NCT04193553

Title: Multicentre Placebo-controlled Double-blinded Phase II Study of Lenvatinib Efficacy in Patients With Locally Advanced or Metastatic GIST (Gastrointestinal Stromal Tumor) After Imatinib/Sunitinib Failure 
Study Summary: The primary objective is to compare the efficacy of lenvatinib plus Best Supportive Care versus Placebo plus Best Supportive Care in the treatment of patients with advanced GIST, after failure of imatinib and sunitinib. 
Sponsor: Centre Leon Berard 
Intervention: Lenvatinib 
Start Date: 2020-01-17 
Last Updated: 2023-03-29 
Number of Patients: 74 
Recruitment Status: RECRUITING 
Condition: Gastro Intestinal Stromal Tumour 

NCTID: NCT03386162

Title: SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer 
Study Summary: SAFIR PI3K is an open-label multicenter phase II randomized trial, comparing alpelisib plus fulvestrant to maintenance chemotherapy in patient PIK3CA mutated with HR+/Her2- metastatic breast cancer who do not present progressive disease after 6-8 cycles of 1st or second line chemotherapy.  The primary objective is to determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival (PFS) compared to maintenance chemotherapy in patients PIK3CA mutated with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who do not present a progressive disease after 6-8 cycles of chemotherapy. 
Sponsor: UNICANCER 
Intervention: Alpelisib 
Start Date: 2018-03-15 
Last Updated: 2022-11-28 
Number of Patients: 31 
Recruitment Status: TERMINATED 
Condition: Breast Cancer, PI3K, Alpelisib 

NCTID: NCT05296746

Title: Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer 
Study Summary: This is an open-label, multicenter international trial in men and women with primary operable HR+/HER2-, ki67≥20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant ribociclib and letrozole.  This study aims to evaluate whether chemotherapy could be avoided for initial high-risk clinicopathological breast cancer patients that are converted to low genomic risk assessed by Risk of Recurrence-low (ROR-low) at 6 months of letrozole - ribociclib neoadjuvant treatment by continuing with this treatment in adjuvant setting. 
Sponsor: SOLTI Breast Cancer Research Group 
Intervention: Ribociclib (neoadjuvant) 
Start Date: 2022-05-03 
Last Updated: 2023-10-10 
Number of Patients: 1100 
Recruitment Status: RECRUITING 
Condition: Breast Cancer Stage II 

NCTID: NCT03486873

Title: Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) 
Study Summary: The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.  This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.  Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2018-08-21 
Last Updated: 2023-11-27 
Number of Patients: 2300 
Recruitment Status: RECRUITING 
Condition: Solid Tumors 

NCTID: NCT04595565

Title: Sacituzumab Govitecan in Primary HER2-negative Breast Cancer 
Study Summary: Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to:  * Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles); * Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation.  Treatment in either arm will be given for eight cycles.  In patients with HR-positive breast cancer, endocrine-based therapy, which includes the use of CDK4/6 inhibitors, will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents.  Adjuvant pembrolizumab can be given until the completion of radiotherapy before randomization. Within the study the use of pembrolizumab in patients with TNBC who received pembrolizumab as neoadjuvant therapy is allowed as monotherapy in the TPC arm, according to the approval of pembrolizumab in this setting. 
Sponsor: German Breast Group 
Intervention: Capecitabine 
Start Date: 2020-10-28 
Last Updated: 2023-03-02 
Number of Patients: 1332 
Recruitment Status: RECRUITING 
Condition: HER2-negative Breast Cancer 

NCTID: NCT04795661

Title: Immunotherapy in MSI/dMMR Tumors in Perioperative Setting. 
Study Summary: This trial is a multicenter, 4-cohort, prospective, Phase II trial conducted in patients with untreated resectable MSI/dMMR carcinomas or EBV+ gastric cancer and aiming to evaluate the safety and the efficacy of ICI (immune checkpoint inhibitor) as neoadjuvant treatment in these patients.  We hypothesize that immune checkpoint inhibitors (ICPi) will benefit to MSI/dMMR tumors from the early stages, whatever their anatomical origin. We assume that this neoadjuvant treatment would improve the response rate, providing even high rate of pathological complete responses and prolong patients survival.  We anticipated endometrial, colorectal and gastric cancers to be the most frequent recruited and constructed our statistical hypothesis with results in those 3 cancers. However patients with other localized MSI/dMMR tumors could be included. 
Sponsor: Centre Leon Berard 
Intervention: Pembrolizumab 
Start Date: 2021-10-18 
Last Updated: 2023-07-19 
Number of Patients: 160 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Localized Resectable Tumor 

NCTID: NCT03793361

Title: Phase II Study of Regorafenib as Maintenance Therapy 
Study Summary: Multicenter double-blind placebo-controlled randomized Phase II study comparing regorafenib® to placebo, as maintenance therapy in metastatic soft-tissue non-adipocytic sarcomas experiencing stable disease or response after 6 cycles of doxorubicin-based chemotherapy as 1st line chemotherapy. 
Sponsor: Centre Oscar Lambret 
Intervention: Regorafenib 
Start Date: 2019-05-15 
Last Updated: 2023-06-23 
Number of Patients: 126 
Recruitment Status: SUSPENDED 
Condition: Metastatic Soft Tissue Sarcoma 

NCTID: NCT01663753

Title: Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy 
Study Summary: Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment. Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to treatment before surgery. A positive predictive value of 75% was found in a small study making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach. Diffusion-weighted MRI was also described as an early and sensitive indicator in other diseases.  Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted MRI diagnostic performances.  Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2 cervical SCC recruited over 2.5 years in 24 centers in France. Each patient will undergo a 18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the brachytherapy. The total follow-up duration (study participation) of patients will be 11 weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until 18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery.  Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it could improve clinical practices and be helpful to decide whether the patient needs surgery or not after radiochemotherapy and brachytherapy. 
Sponsor: Hospices Civils de Lyon 
Intervention: 18F-FDG-PET 
Start Date: 2012-03 
Last Updated: 2019-01-07 
Number of Patients: 146 
Recruitment Status: COMPLETED 
Condition: Cancer of the Uterine Cervix 

NCTID: NCT03665129

Title: IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors 
Study Summary: This is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, antitumor activity of IPH5401 (anti C5aR) in combination with Durvalumab (MEDI4736) in Adult Subjects with selected advanced solid tumors. 
Sponsor: Innate Pharma 
Intervention: IPH5401 and Durvalumab 
Start Date: 2018-09-07 
Last Updated: 2022-01-27 
Number of Patients: 73 
Recruitment Status: TERMINATED 
Condition: Advanced Solid Tumors 

NCTID: NCT04221035

Title: High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) 
Study Summary: This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma. 
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris 
Intervention: Vincristine 
Start Date: 2019-11-05 
Last Updated: 2023-02-13 
Number of Patients: 800 
Recruitment Status: RECRUITING 
Condition: High-Risk Neuroblastoma 

NCTID: NCT03126435

Title: EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX 
Study Summary: The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure. 
Sponsor: SynCore Biotechnology Co., Ltd. 
Intervention: EndoTAG-1 
Start Date: 2018-10-16 
Last Updated: 2023-05-06 
Number of Patients: 218 
Recruitment Status: COMPLETED 
Condition: Metastatic Pancreas Cancer 

NCTID: NCT05050942

Title: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET 
Study Summary: The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029. 
Sponsor: Camurus AB 
Intervention: CAM2029 
Start Date: 2021-10-22 
Last Updated: 2023-10-06 
Number of Patients: 300 
Recruitment Status: RECRUITING 
Condition: Gastro-enteropancreatic Neuroendocrine Tumor 

NCTID: NCT05116189

Title: Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65) 
Study Summary: The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score <math display="block">CPS</math> ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-12-13 
Last Updated: 2023-08-08 
Number of Patients: 616 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Ovarian Cancer 

NCTID: NCT03878342

Title: Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast 
Study Summary: Following breast-conserving surgery (BCS) for localized ductal carcinoma in situ (DCIS) of the breast, whole-breast irradiation (WBRT) is a standard of care, reducing the absolute rate of in-breast recurrences (IBR) by more than 15% at 10 years, from 28% without radiotherapy to 13 % with radiotherapy. Half of the recurrences occurred as invasive disease. Whereas in the comparative trials, WBRT did not impact on overall survival, survival of patients who recurred with invasive cancers was impaired in comparison to patients who did not recur, or to patients with DCIS-only recurrences.  Using criteria based on age, tumor size, nuclear grade, and margins status, several trials and cohort studies failed to identify subgroups of patients at low risk, who could be safely spared the need for WBRT. The Radiation Therapy Oncology Group (RTOG) DCIS trial included patients treated with BCS for low- or intermediate grade DCIS revealed by unifocal microcalcifications, size ≤25 mm, margins ≥3 mm, and no residual microcalcifications after surgery. The 5-year rates of IBR were 3.5 % without radiotherapy, versus 0.4 % with radiotherapy, and 6.7 % and 0.9 % at 7 years, respectively (p <0.001). Sixty percent of the patients received tamoxifen in both groups.  Several studies showed that the same molecular classes were identified in DCIS as in invasive cancers. Studies suggested that low proliferation, hormone receptors expression, and lack of ERBB2 amplification were associated with a low risk of IBR in patients not receiving radiotherapy. A combined signature was tested in the Eastern Cooperative Oncology Group (ECOG) trial, showing a 10% IBR rate at ten years in patients with a low-risk.  Identifying very low-risk DCIS, using biological markers in addition to the clinical and histological markers of low-risk DCIS, could help to select patients who could be safely avoided WBRT following BCS. It would avoid over-treatment in these women and could decrease the cost of management. 
Sponsor: UNICANCER 
Intervention: Radiotherapy 
Start Date: 2019-05-10 
Last Updated: 2022-08-02 
Number of Patients: 300 
Recruitment Status: RECRUITING 
Condition: DCIS 

NCTID: NCT00982865

Title: Trial of MSC1936369B in Subjects With Solid Tumors 
Study Summary: This is a first in man trial with a primary objective being the determination of the Maximum Tolerated dose (MTD) and the dose-limiting toxicity (DLT) in several regimens of MEK inhibitor MSC1936369B administered orally once a day, in subjects with malignant solid tumors to see how safe is treatment with MSC1936369B. 
Sponsor: Merck KGaA, Darmstadt, Germany 
Intervention: MSC1936369B 
Start Date: 2007-12-31 
Last Updated: 2018-10-23 
Number of Patients: 182 
Recruitment Status: COMPLETED 
Condition: Solid Tumors 

NCTID: NCT04931342

Title: A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors 
Study Summary: This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase. 
Sponsor: Hoffmann-La Roche 
Intervention: Ipatasertib 
Start Date: 2021-10-07 
Last Updated: 2023-11-07 
Number of Patients: 550 
Recruitment Status: RECRUITING 
Condition: Ovarian Cancer 

NCTID: NCT01479465

Title: Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma 
Study Summary: The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen. 
Sponsor: Gilead Sciences 
Intervention: Simtuzumab 
Start Date: 2011-12 
Last Updated: 2019-04-17 
Number of Patients: 266 
Recruitment Status: TERMINATED 
Condition: Colorectal Cancer 

NCTID: NCT01837251

Title: Evaluation of Optimal Treatment With Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer 
Study Summary: Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and PLD/carboplatin. 
Sponsor: AGO Research GmbH 
Intervention: Carboplatin 
Start Date: 2013-05 
Last Updated: 2021-07-13 
Number of Patients: 682 
Recruitment Status: COMPLETED 
Condition: Recurrent Platinum-sensitive Ovarian Cancer 

NCTID: NCT02363751

Title: Study of Gemcitabine+Platinum Salt+Bevacizumab Combination for Metastatic Collecting Duct Carcinoma (GETUG-AFU 24) 
Study Summary: Open-label, non-randomized, multicenter, phase II, single arm non comparative trial evaluating toxicity and efficacy of gemcitabine plus platinum salt in combination with bevacizumab in first-line setting in metastatic collecting duct carcinoma. 
Sponsor: UNICANCER 
Intervention: Bevacizumab 
Start Date: 2014-12 
Last Updated: 2021-03-09 
Number of Patients: 36 
Recruitment Status: COMPLETED 
Condition: Collecting Duct Carcinoma (Kidney) 

NCTID: NCT00212121

Title: Radiation Dose Intensity Study in Breast Cancer in Young Women 
Study Summary: hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis. 
Sponsor: The Netherlands Cancer Institute 
Intervention: high dose boost 
Start Date: 2004-07 
Last Updated: 2022-01-21 
Number of Patients: 2400 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT01125566

Title: LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment 
Study Summary: To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment 
Sponsor: Boehringer Ingelheim 
Intervention: BIBW 2992 
Start Date: 2010-06-22 
Last Updated: 2019-07-18 
Number of Patients: 508 
Recruitment Status: COMPLETED 
Condition: Breast Neoplasms 

NCTID: NCT05382286

Title: Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer 
Study Summary: The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician’s choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1). 
Sponsor: Gilead Sciences 
Intervention: Sacituzumab Govitecan-hziy 
Start Date: 2022-07-25 
Last Updated: 2023-11-15 
Number of Patients: 440 
Recruitment Status: RECRUITING 
Condition: Triple Negative Breast Cancer 

NCTID: NCT05552066

Title: Anticipated Personalization of the Management in Day Hospital Unit Based on a Collection of the PROs Via a Digital Tool 
Study Summary: The present study proposes a new organization of the Day Hospital unit with several possible pathways defined by PRO.  The organization realies on a platform composed of nurses supervised by an IPA and a doctor one day before a treatment in the day hospitalization unit admission, results of PROs collectyed through the [[1]] application (a French health care application) are reviewed by nurses from the platform and chemotherapy delivery is confirmed.  The study is planed in 2 steps.  # st stage: the current circuit remains unchanged (with systematic medical or nursing validation to confirm chemotherapy administration. Patient satisfaction is collected at each visit to the day hospital unit for chemotherapy. 73 patients will be included in this phase. # nd stage: a short circuit is set up. If no contraindications are identified by the plateform with the remote PRO collection, patients will undergo chemotherapy directly the next day (without any medical validation. Patient satisfaction is also collected at each visit to the day hospital unit for chemotherapy. 73 patients will be included in this phase. 
Sponsor: Center Eugene Marquis 
Intervention: Standard follow up 
Start Date: 2022-01-11 
Last Updated: 2023-03-29 
Number of Patients: 146 
Recruitment Status: RECRUITING 
Condition: Solid Malignant Tumor 

NCTID: NCT00873119

Title: Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary 
Study Summary: The purpose of this study is to assess efficacy and safety of belinostat in combination with carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown primary. 
Sponsor: Onxeo 
Intervention: belinostat, carboplatin, paclitaxel 
Start Date: 2009-02 
Last Updated: 2015-07-28 
Number of Patients: 89 
Recruitment Status: COMPLETED 
Condition: Carcinoma of Unknown Primary 

NCTID: NCT04985266

Title: A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer 
Study Summary: Detection of molecular relapse with circulating tumour DNA analysis can identify which patients with ER positive breast cancer are relapsing on adjuvant endocrine therapy. This trial will aim to demonstrate that palbociclib and fulvestrant, can defer or prevent relapse in patients with ctDNA detected molecular relapse.  The TRAK-ER trial will have two phases, a ctDNA surveillance phase and a randomised therapy trial in patients with positive ctDNA.  The TRAK-ER trial will establish a ctDNA screening programme for patients with ER positive breast cancer receiving adjuvant endocrine therapy with at least a further three years of standard adjuvant endocrine therapy planned. Patients recruited into the TRAK-ER study will have high-risk clinical features to identify patients at higher risk of future relapse.  ctDNA assays will be used to identify which people are at very high risk of relapse (i.e. those with a positive ctDNA result), and randomise this high risk population between standard endocrine therapy versus palbociclib plus fulvestrant for up to two years. 
Sponsor: Royal Marsden NHS Foundation Trust 
Intervention: Palbociclib 125Mg Tab 
Start Date: 2022-03-30 
Last Updated: 2023-08-25 
Number of Patients: 1100 
Recruitment Status: RECRUITING 
Condition: ER+ Breast Cancer 

NCTID: NCT05443087

Title: TARGETed Therapy Drug MONITOring in DIGestive Oncology 
Study Summary: Targeted therapy drug monitoring in digestive oncology: Dosage of plasma levels of various multikinase inhibitors (MKI) in patients treated for advanced digestive cancer (gastrointestinal stromal tumor (GIST), metastatic colorectal cancer (mCRC), hepatocellular carcinoma (HCC), gastroenteropancreatic neuroendocrine tumor (gepNET), or pancreatic neuroendocrine tumor (pNET)), with the aim of determine the optimal dose adapted for each patient, in the future. 
Sponsor: UNICANCER 
Intervention: Blood sampling to build population pharmacokinetics model 
Start Date: 2022-08-29 
Last Updated: 2023-11-13 
Number of Patients: 330 
Recruitment Status: RECRUITING 
Condition: Digestive Cancer 

NCTID: NCT01357486

Title: Palliative Treatment of Hepatocellular Carcinoma in Patient With CHILD B Cirrhosis 
Study Summary: The incidence of Hepatocellular Carcinoma (HCC) is currently increasing in Europe and in France and about 2 / 3 of patients, are not eligible for curative treatment at the time of diagnosis. The palliative management of patients with advanced and symptomatic disease is complex and requires treatment combining anti-tumor activity and safety in patients with impaired liver functions. Sorafenib is the standard of care in a palliative setting, but the benefit of sorafenib in patient with altered liver function is uncertain. The aim of this trial is to study the interest of sorafenib in patients with HCC and impaired liver function compared to pravastatin (a drug with anti-tumoral activity in HCC) or to the combination sorafenib/pravastatin or to best supportive care (usually used in these patients). 
Sponsor: University Hospital, Bordeaux 
Intervention: sorafenib 
Start Date: 2011-11-14 
Last Updated: 2017-05-01 
Number of Patients: 160 
Recruitment Status: COMPLETED 
Condition: Hepatocellular Carcinoma 

NCTID: NCT03946033

Title: Impact of Immunoscore Colon Test on Adjuvant Therapeutic Strategy in Non-Metastatic Colon Cancer
Study Summary: Immunoscore Colon Test (ICT) will be applied on tumor samples from curative surgery. In the Multidisciplinary Meeting (MM) evaluating the participant adjuvant strategy, a first decision will be taken, based on the participant medical record only. ICT will then be disclosed and the MM will take a second decision. The aim of the study is to observe if the ICT result modifies the treatment decision. 
Sponsor: UNICANCER 
Intervention: Immunoscore Colon Test 
Start Date: 2019-05 
Last Updated: 2019-08-30 
Number of Patients: 0 
Recruitment Status: WITHDRAWN 
Condition: Colonic Neoplasms 

NCTID: NCT03132792

Title: AFPᶜ³³²T in Advanced HCC 
Study Summary: This first time in human study is intended for men and women between 18 and 75 years of age who have advanced liver cancer which has grown or returned after being treated or another AFP expressing tumor. Those who did not tolerate or refused other therapies may also participate. The purpose of this study is to test the safety of genetically changed T cells that target alpha-fetoprotein (AFP) and find out what effects, if any, they have in subjects with liver cancer or other AFP expressing tumor types. This study is for subjects who have a blood test positive for appropriate HLA-A*02 P Group and have adequate AFP protein in blood or tumor, and whose noncancerous liver tissue has very little AFP protein (Liver only).  The study will take the subject’s T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject’s own T cells that have been genetically changed with the aim of attacking and destroying cancer cells.  The manufacturing of T cells takes about 1 month to complete. The T cells will be given back to the subject through an intravenous infusion after 3 days of chemotherapy. The study will evaluate three different cell dose levels in order to find out the target cell dose. Once the target cell dose is determined, additional subjects will be enrolled to further test the safety and effects at this cell dose.  Subjects will be hospitalized for at least 1 week after receiving their T cells back and then seen frequently by the Study Physician for the next 6 months. After that, subjects will be seen every three months. If subjects have disease progression or withdraw from the study, they will then be entered into a long-term follow up for safety monitoring. In long-term follow up, subjects will be seen every 6 months by their Study Physician for the first 5 years after the T cell infusion and annually for the next 10 years. 
Sponsor: Adaptimmune 
Intervention: Autologous genetically modified AFPᶜ³³²T cells 
Start Date: 2017-05-08 
Last Updated: 2022-08-29 
Number of Patients: 45 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Hepatocellular Cancer 

NCTID: NCT05645692

Title: A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer 
Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig alone or in combination with tiragolumab compared with atezolizumab in participants with previously untreated, locally advanced or metastatic urothelial cancer (mUC) who are ineligible to receive a platinum containing chemotherapy. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2023-04-13 
Last Updated: 2023-11-07 
Number of Patients: 240 
Recruitment Status: RECRUITING 
Condition: Urothelial Cancer 

NCTID: NCT04132960

Title: Study of DS-8201a, an Antibody Drug Conjugate for Advanced Breast Cancer Patients, With Biomarkers Analysis 
Study Summary: Multicenter, open-label phase II trial assessing the efficacy of DS-8201a monotherapy in patients with metastatic breast cancer. 
Sponsor: UNICANCER 
Intervention: DS-8201a 
Start Date: 2019-10-21 
Last Updated: 2022-02-02 
Number of Patients: 186 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Tumors 

NCTID: NCT02052778

Title: A Study of TAS-120 in Patients With Advanced Solid Tumors 
Study Summary: This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be conducted in 3 parts:  # Dose escalation portion to determine the MTD and/ or RP2D of futibatinib. # Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in patients with tumors harboring FGF/FGFR aberrations, including patients with cholangiocarcinoma (CCA), primary CNS tumors, urothelial carcinoma, breast cancer, gastric cancer. # Phase 2 study portion to confirm ORR of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions). 
Sponsor: Taiho Oncology, Inc. 
Intervention: Futibatinib 
Start Date: 2014-07 
Last Updated: 2022-01-10 
Number of Patients: 386 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Cholangiocarcinoma 

NCTID: NCT03412058

Title: Identifying the Predictive Factors of Response to PD-1 or PD-L1 Antagonists 
Study Summary: This is a prospective cohort study which aims to identify predictive factors of response to PD-1 and PD L1 antagonists authorised for use in France in treatment of melanoma, NSCLC, or HNSCC. 
Sponsor: UNICANCER 
Intervention: Biopsy 
Start Date: 2018-06-27 
Last Updated: 2023-09-06 
Number of Patients: 670 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Melanoma 

NCTID: NCT04307277

Title: Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma 
Study Summary: Phase III, multicenter, randomized open-label and comparative study designed to demonstrate whether adding 4 cycles of peri-operative doxorubicin-based chemotherapy improves metastasis-free survival as compared with standard management in patients with resectable STS, considered as high-risk according to CINSARC (Complexity Index in SARComas) signature.  After signed informed consent, patients considered as eligible to CHIC-STS study by the investigator will be enrolled in the study and a molecular screening will be performed (600 patients will be screened).  Patients considered as low-risk according to CINSARC signature will be treated at the discretion of the clinicians (prospective cohort).  Patients considered as high-risk according to CINSARC signature will be randomized in the open-label multicenter phase III trial and assigned in one of the two following treatments arms:  * Arm A (control arm): Standard of care (surgical excision +/- external radiotherapy). * Arm B (experimental arm): Standard of care + 4 cycles of intravenous chemotherapy during 12 weeks.  A total of 250 patients will have to be randomized with 125 patients in each arm. 
Sponsor: Institut Claudius Regaud 
Intervention: Standard of care + chemotherapy 
Start Date: 2020-10-09 
Last Updated: 2023-02-27 
Number of Patients: 600 
Recruitment Status: RECRUITING 
Condition: Soft Tissue Sarcoma 

NCTID: NCT05219318

Title: Treatment Pause Versus Treatment Continuation in IMDC Good or Intermediate Risk With Only One Adverse Prognostic Factor in mRCC Patients With an Objective Response at 12 Months of Treatment With PD1/ PDL1 ICIs + VEGFR-Tyrosine Kinase Inhibitors 
Study Summary: The purpose of this study is to demonstrate the non-inferiority of treatment pause versus treatment continuation in good or intermediate risk with only one adverse prognostic factor as per IMDC mRCC patients with a confirmed objective response at 12 months of treatment with PD-1/PD-L1 ICI plus VEGFR-TKI.  Tolerance and quality of life of treatment pause with PD-1/PD-L1 ICI + VEGFR-TKI compared to treatment continuation will be reported. In France, its impact on healthcare resource utilization will also be assessed. 
Sponsor: University Hospital, Bordeaux 
Intervention: Combination PD-1/PD-L1 ICI + VEGFR-TKI 
Start Date: 2023-01-23 
Last Updated: 2023-03-13 
Number of Patients: 372 
Recruitment Status: RECRUITING 
Condition: Metastatic Renal Cell Carcinoma 

NCTID: NCT05846594

Title: A Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer 
Study Summary: This is an international, prospective study to assess the impact of concomitant early use of liquid biopsy (FoundationOne® Liquid CDx) within the diagnostic pathway, compared with the standard of care diagnostic pathway, on the timing of routine cancer care in treatment-naïve participants presenting with a clinical diagnosis of advanced cancer, where the pathologic diagnosis has not yet been confirmed. Participants with one of the following two clinical presentations will be included: participants with evidence of de novo metastatic lung cancer or participants with evidence of de novo metastatic gastrointestinal cancer.  Participants may have undergone different levels of diagnostic workup prior to enrollment. Participants who have not had tissue biopsy performed prior to enrollment will be classified as ‘basic workup’ and those who have had tissue biopsy performed prior to enrollment will be classified as ‘extended workup’.  During the diagnosis period, eligible participants will undergo liquid biopsy (FoundationOne® Liquid CDx assay; as per label) on blood samples. Blood samples will be tested using the FoundationOne® Liquid CDx assay at a central laboratory. In parallel, participants will undergo the standard of care diagnostic pathway, including tissue biopsy and histology workup, if not already done before enrollment, and molecular workup according to ESMO guidelines or national guidelines for each tumor type included in this study.  Once a complete pathologic diagnosis has been made, the investigator (or multidisciplinary team) can complete an anti-cancer treatment recommendation assessment. Anti-cancer treatment recommendation should follow current practice and professional guidelines based on the results provided by either liquid biopsy (as per label) or tissue biopsy/standard of care. 
Sponsor: Hoffmann-La Roche 
Intervention: FoundationOne® Liquid CDx Assay 
Start Date: 2023-09-14 
Last Updated: 2023-11-18 
Number of Patients: 520 
Recruitment Status: RECRUITING 
Condition: Metastatic Lung Cancer 

NCTID: NCT02704832

Title: Role of Geriatric Intervention in Treatment of Older Patients With Cancer (PREPARE) 
Study Summary: Randomized trials have already demonstrated that geriatric intervention was able to improve survival in the general elderly population but only a few have been performed in cancer patients. At the end, these data are not sufficient to consider geriatric intervention as validated in this setting. Case Management, coordinated by a geriatrician and a trained nurse, could improve prognosis of elderly patients with cancer. This approach, can be integrated in daily oncology practice. This strategy will be compared to usual oncological management in a randomized phase III trial. 
Sponsor: Institut Bergonié 
Intervention: Geriatrician Intervention 
Start Date: 2016-03 
Last Updated: 2017-11-20 
Number of Patients: 1500 
Recruitment Status: UNKNOWN 
Condition: Breast Cancer 

NCTID: NCT03306394

Title: A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic). 
Study Summary: The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC).  Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor’s prescription or can be accessed from another source or Sponsor decision. 
Sponsor: Institut de Recherches Internationales Servier 
Intervention: Trifluridine/Tipiracil hydrochloride (S95005) 
Start Date: 2016-10-18 
Last Updated: 2021-11-17 
Number of Patients: 907 
Recruitment Status: COMPLETED 
Condition: Metastatic Colorectal Cancer 

NCTID: NCT05615818

Title: Personalized Medicine for Advanced Biliary Cancer Patients 
Study Summary: The object of this trial is to evaluate whether the introduction of a targeted therapy after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is superior to continuing with the standard treatment.  The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, during which a molecular profile of the patient’s tumour will be obtained, and (ii) a randomised comparative trial in which patients with disease control after 4 cycles of standard treatment, and whose tumour harbours a targetable molecular alteration, will be randomised (2:1) to receive either a matched targeted therapy or to continue with the standard treatment. 
Sponsor: UNICANCER 
Intervention: Futibatinib 
Start Date: 2024-01 
Last Updated: 2023-11-18 
Number of Patients: 800 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Biliary Tract Neoplasms 

NCTID: NCT01210495

Title: Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma 
Study Summary: The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma. 
Sponsor: Pfizer 
Intervention: Axitinib (AG-013736) 
Start Date: 2010-12-06 
Last Updated: 2019-01-09 
Number of Patients: 224 
Recruitment Status: COMPLETED 
Condition: Hepatocellular Carcinoma 

NCTID: NCT05183984

Title: Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer 
Study Summary: Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy +/-bevacizumab. 
Sponsor: ARCAGY/ GINECO GROUP 
Intervention: Chemotherapy 
Start Date: 2022-02-01 
Last Updated: 2022-12-06 
Number of Patients: 390 
Recruitment Status: RECRUITING 
Condition: Ovarian Cancer 

NCTID: NCT04459234

Title: Prospective Multicentre Study of the Use of Ketamine in the Treatment of Refractory Chronic Pain in the French CLCC 
Study Summary: The primary objective of this study is to describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of indication (neuropathic sequelae pains, morphine additional effect or morphine withdrawal, intensity, localisation…) and administration protocol (route, posology, duration, administration sequence, premedication).  The secondary objectives are to evaluate in the context of cancer, the analgesic efficacy, the tolerance profile (biological and clinical toxicities) and the quality of life, including anxiety and depression.  In addition, the described parameters will be evaluated as safety and efficacy predictive factors of the Ketamine in oncology. 
Sponsor: Centre Leon Berard 
Intervention: Ketamine use in CLCC sites (indication and administration protocol) 
Start Date: 2021-02-02 
Last Updated: 2023-09-11 
Number of Patients: 81 
Recruitment Status: COMPLETED 
Condition: Cancer 

NCTID: NCT03255434

Title: LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy 
Study Summary: Cytotoxic chemotherapy is usually scaled to the body surface area (BSA), and is currently not adjusted to the body proportions of lean and fat (i.e. body composition) of individual patients. Patients with low muscle mass behave like patients “overdosed” with chemotherapy resulted in dose-limiting toxicities (e.g. dose reductions, treatment delays or permanent treatment discontinuation), independently of the patient’s weight. 
Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle 
Intervention: Oxaliplatin 
Start Date: 2017-11-01 
Last Updated: 2023-06-18 
Number of Patients: 160 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Stage III Colon Cancer 

NCTID: NCT03504423

Title: Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas 
Study Summary: A prospective, multicenter, open label, randomized phase III study to evaluate efficacy and safety of FFX versus CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years 
Sponsor: Cornerstone Pharmaceuticals 
Intervention: CPI 613, mFolfirinox 
Start Date: 2018-11-09 
Last Updated: 2023-01-03 
Number of Patients: 528 
Recruitment Status: COMPLETED 
Condition: Pancreatic Cancer Metastatic 

NCTID: NCT04976634

Title: Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016) 
Study Summary: The purpose of this study is to determine the safety and efficacy of belzutifan in combination with pembrolizumab and lenvatinib in multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), endometrial cancer (EC),and esophageal squamous cell carcinoma (ESCC). There is no formal hypothesis testing in this study. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-08-18 
Last Updated: 2023-11-18 
Number of Patients: 730 
Recruitment Status: RECRUITING 
Condition: Carcinoma, Hepatocellular 

NCTID: NCT02933801

Title: ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents. 
Study Summary: The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane. 
Sponsor: Swiss Group for Clinical Cancer Research 
Intervention: ODM-201 
Start Date: 2017-03-31 
Last Updated: 2023-03-08 
Number of Patients: 92 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Prostate Cancer Metastatic 

NCTID: NCT01957436

Title: A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer 
Study Summary: This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer. 
Sponsor: UNICANCER 
Intervention: abiraterone acetate 
Start Date: 2013-11-13 
Last Updated: 2023-11-08 
Number of Patients: 1173 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Prostate Cancer 

NCTID: NCT04152941

Title: Real-life Data of Olaparib in Relapsed Ovarian Cancers Patients 
Study Summary: This is a national, multi center, retrospective observational cohort study that will be carried out by reviewing the medical records of patients with relapsed epithelial ovarian, fallopian tube, or peritoneal cancer treated with olaparib following response to platinum-based chemotherapy. 
Sponsor: ARCAGY/ GINECO GROUP 
Intervention: Olaparib 
Start Date: 2018-10-11 
Last Updated: 2023-09-06 
Number of Patients: 130 
Recruitment Status: COMPLETED 
Condition: Relapsed Ovarian Cancers Patients 

NCTID: NCT02834780

Title: Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma 
Study Summary: The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527. 
Sponsor: H3 Biomedicine Inc. 
Intervention: H3B-6527 
Start Date: 2016-12-28 
Last Updated: 2023-11-13 
Number of Patients: 128 
Recruitment Status: COMPLETED 
Condition: Advanced Hepatocellular Carcinoma 

NCTID: NCT00161980

Title: Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites 
Study Summary: This study will monitor the safety of FS VH S/D and will evaluate whether FS VH S/D is superior to conventional surgical procedures in the reduction of lymphatic leakage by sealing the axillary lymphatics in subjects undergoing lumpectomy and level I and II axillary lymph node dissection with two separate incisions. 
Sponsor: Baxter Healthcare Corporation 
Intervention: Fibrin Sealant VH S/D 
Start Date: 2001-06 
Last Updated: 2006-10-23 
Number of Patients: NA 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT03163732

Title: Evaluation of the Added Value of a Large Molecular Profiling Panel Versus a Limited Molecular Profiling Panel in Advanced Solid Tumors. 
Study Summary: The PROFILER 02 program is a multicenter, randomized, prospective cohort study aiming to compare the clinical relevance of a large Next-generation sequencing (NGS) panel (FondationOne or FOne panel) versus a limited NGS panel (CONTROL or CTL panel) in patients with advanced solid tumors.  This study will allow adapting the therapeutic management of these patients, if needed, by giving them recommended therapies (commercialized or in ongoing clinical trials), based on the recommendations of the Molecular Tumor Board (MTB). 
Sponsor: Centre Leon Berard 
Intervention: Blood and tumor samples 
Start Date: 2017-06-29 
Last Updated: 2022-05-09 
Number of Patients: 341 
Recruitment Status: COMPLETED 
Condition: Advanced Solid Tumor 

NCTID: NCT01581840

Title: Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus 
Study Summary: Treatment is based on radiochemotherapy for locally advanced tumours. The objective of treatment is to provide a cure without resorting to abdominoperineal amputation, while preserving sphincter function.  The prognosis is mainly related to tumour size and lymph node invasion. The large majority of patients do not show any spread remote from the tumour at the time of diagnosis (2).  Recurrences are mainly of a local/regional nature and require abdominoperineal amputation. This type of intervention is not always possible or complete, which then gives rise to the particularly distressing risk of local progression, with survival at 3 years of approximately 30% (3).  It is therefore very important to achieve a complete and permanent tumour response from initial treatment with radiochemotherapy.  Furthermore, the use of an anti-EGFR antibody in combination with exclusive radiotherapy in ENT cancer was able to increase recurrence-free survival and overall survival in these patients. These data are in favour of the use of a combination of chemotherapy and anti-EGFR antibodies in epidermoid cancer of the anus. 
Sponsor: Federation Francophone de Cancerologie Digestive 
Intervention: radiochemotherapy 
Start Date: 2012-06 
Last Updated: 2022-04-04 
Number of Patients: 45 
Recruitment Status: COMPLETED 
Condition: Epidermoid Carcinoma 

NCTID: NCT02891824

Title: ATALANTE: Atezolizumab vs Placebo Phase III Study in Late Relapse Ovarian Cancer Treated With Chemotherapy+Bevacizumab 
Study Summary: This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess the efficacy of atezolizumab in combination with platinum-based chemotherapy plus bevacizumab administered concurrent to chemotherapy and in maintenance, in patients presenting epithelial ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) who have platinum-sensitive relapse (platinum-free interval > 6 months). 
Sponsor: ARCAGY/ GINECO GROUP 
Intervention: atezolizumab + avastin + platinum-based chemotherapy 
Start Date: 2016-09-22 
Last Updated: 2023-07-21 
Number of Patients: 614 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Ovarian Cancer 

NCTID: NCT05733598

Title: RP3 in Combination With 1L or 2L Therapy in Patients With Locally Advanced Unresectable or Metastatic HCC 
Study Summary: This is a Phase 2, open-label, 2-cohort clinical study evaluating RP3 in combination with atezolizumab plus bevacizumab as First- or Second-line Systemic Therapy in patients with locoregionally advanced and/or metastatic Hepatocellular Carcinoma not amenable to surgical resection or standard locoregionally directed therapies. 
Sponsor: Replimune Inc. 
Intervention: RP3 
Start Date: 2024-02-29 
Last Updated: 2023-11-18 
Number of Patients: 60 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Locally Advanced Hepatocellular Carcinoma 

NCTID: NCT02477644

Title: Platine, Avastin and OLAparib in 1st Line 
Study Summary: Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance. 
Sponsor: Arcagy Research 
Intervention: Olaparib 
Start Date: 2015-05-06 
Last Updated: 2022-08-02 
Number of Patients: 806 
Recruitment Status: COMPLETED 
Condition: Ovarian Cancer 

NCTID: NCT03326674

Title: Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC 
Study Summary: CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (PFS) as assessed by the Independent Radiologic Review Committee (IRC). 685 patients were enrolled. 
Sponsor: Odonate Therapeutics, Inc. 
Intervention: Tesetaxel and Capecitabine 
Start Date: 2017-12-21 
Last Updated: 2021-07-30 
Number of Patients: 685 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT04702581

Title: A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery 
Study Summary: Because of their prolonged survival, patients with 1p/19q-codeleted low-grade oligodendrogliomas treated with RT + PCV are at risk of neurocognitive deterioration. We make the hypothesis that withholding radiotherapy until tumor progression could reduce the risk of neurocognitive deterioration without impairing overall survival. 
Sponsor: Hospices Civils de Lyon 
Intervention: PCV chemotherapy 
Start Date: 2021-12-07 
Last Updated: 2023-06-02 
Number of Patients: 280 
Recruitment Status: RECRUITING 
Condition: Oligodendroglioma 

NCTID: NCT05218499

Title: Brightline-1: A Study to Compare BI 907828 With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma 
Study Summary: This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate.  The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma.  During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin treatment.  Participants can continue treatment in the study as long as they benefit from it and can tolerate it.  Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants’ health and take note of any unwanted effects. 
Sponsor: Boehringer Ingelheim 
Intervention: BI 907828 
Start Date: 2022-03-25 
Last Updated: 2023-11-07 
Number of Patients: 400 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Liposarcoma, Dedifferentiated 

NCTID: NCT02299999

Title: SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer 
Study Summary: Open label multicentric phase II randomized trial, using high throughput genome analysis as a therapeutic decision tool, which aims at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with maintenance chemotherapy (targeted substudy 1) as well as immunotherapy with maintenance chemotherapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2). 
Sponsor: UNICANCER 
Intervention: AZD2014 
Start Date: 2014-04-07 
Last Updated: 2023-02-06 
Number of Patients: 1460 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Breast Cancer 

NCTID: NCT05382299

Title: Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician’s Choice in Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer 
Study Summary: The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician’s choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1. 
Sponsor: Gilead Sciences 
Intervention: Sacituzumab Govitecan-hziy 
Start Date: 2022-07-20 
Last Updated: 2023-11-15 
Number of Patients: 540 
Recruitment Status: RECRUITING 
Condition: Triple Negative Breast Cancer