Trials (Institut Sainte Catherine)
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NCTID: NCT01300143
Title: Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma Study Summary: Indication : Hepatocellular carcinoma, maximum size 9 cm, with single or multiple nodes whose total tumor mass can technically be irradiated, non-resectable, and not a candidate for percutaneous therapy with recommended treatment via hyperselective transarterial chemoembolisation (TACE). Sponsor: Nantes University Hospital Intervention: TACE Start Date: 2011-06 Last Updated: 2021-12-27 Number of Patients: 126 Recruitment Status: COMPLETED Condition: Hepatocellular Carcinoma
NCTID: NCT01508000
Title: Efficacy of FOLFOX Alone, FOLFOX Plus Bevacizumab and FOLFOX Plus Panitumumab in Patients With Resectable Liver Metastases Study Summary: Patients presenting with multiple innumerable liver metastases will probably never come to resection, however, for all others, including patients with numerous multiple metastases or large metastases,resection should be considered after limited chemotherapy. There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin. FOLFOX was used in the previous EORTC study and is again recommended. The addition of targeted agents to standard chemotherapy in the perioperative strategy for mCRC might increase the ORR and R0 resectability, without significant increase in toxicity, therefore translating to a better outcome. It was therefore decided to design an open label, randomized, multi-center, 3-arm late phase II study. Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Bevacizumab + Surgery Arm C: (experimental) mFOLFOX6 + Panitumumab + Surgery Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: FOLFOX6 Start Date: 2013-06 Last Updated: 2016-10-12 Number of Patients: 44 Recruitment Status: TERMINATED Condition: Colorectal Cancer Metastatic
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: NCT02979483
Title: Management of Symptomatic Advanced Pancreatic Adenocarcinoma Study Summary: This study assessed the feasibility and effects of an early integrative supportive care program in patient with Advanced pancreatic adenocarcinoma (aPDAC). Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: Integrative supportive care Start Date: 2016-11 Last Updated: 2019-02-27 Number of Patients: 110 Recruitment Status: UNKNOWN Condition: Pancreas
NCTID: NCT00064207
Title: Gemcitabine and Radiation Therapy Compared With Gemcitabine Alone in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer Study Summary: RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving gemcitabine together with radiation therapy is more effective than gemcitabine alone following surgery in treating pancreatic cancer. PURPOSE: This randomized phase II/III trial is studying how well giving gemcitabine together with radiation therapy works and compares it to gemcitabine alone in treating patients who have undergone surgery for pancreatic cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: gemcitabine hydrochloride Start Date: 2003-05 Last Updated: 2012-09-24 Number of Patients: 97 Recruitment Status: COMPLETED Condition: Pancreatic Cancer
NCTID: NCT02302807
Title: A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] Study Summary: This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody Start Date: 2015-01-13 Last Updated: 2019-08-01 Number of Patients: 931 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: 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: 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: NCT03038100
Title: A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Study Summary: This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery. Sponsor: Hoffmann-La Roche Intervention: Paclitaxel Start Date: 2017-03-08 Last Updated: 2023-02-17 Number of Patients: 1301 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT01272037
Title: Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer Study Summary: This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy 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. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer. Sponsor: National Cancer Institute (NCI) Intervention: Anastrozole Start Date: 2011-01-15 Last Updated: 2023-11-14 Number of Patients: 5018 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Ductal Carcinoma In Situ
NCTID: NCT03191487
Title: Evaluation of a New Organization for Collecting Pre-chemotherapy Session Information Study Summary: The primary objective of this study is to compare an experimental organization for chemotherapy session planning based on early, standardized, and prioritized means of data transmission via secure e-mail (laboratory results) and the use of a smart phone (for clinical toxicity data) compared to the regular organization, in terms of the rate of prescriptions of chemotherapy prepared at the latest the day before a session and then administered in full (over a 6-month observation period) among colorectal cancer patients in need of cancer treatment in an outpatient setting. Sponsor: Centre Hospitalier Universitaire de Nīmes Intervention: ChimioPal Start Date: 2018-04 Last Updated: 2017-06-19 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Colorectal Neoplasms
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: 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: 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: NCT03155997
Title: Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer Study Summary: The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer. Sponsor: Eli Lilly and Company Intervention: Abemaciclib Start Date: 2017-07-12 Last Updated: 2023-07-14 Number of Patients: 5637 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT03725059
Title: Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab (K) Start Date: 2018-12-27 Last Updated: 2023-09-28 Number of Patients: 1240 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: 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: NCT03493854
Title: A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer Study Summary: This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting. Sponsor: Hoffmann-La Roche Intervention: Cyclophosphamide Start Date: 2018-06-14 Last Updated: 2023-06-15 Number of Patients: 500 Recruitment Status: COMPLETED Condition: Early Breast Cancer
NCTID: NCT04210115
Title: Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) Study Summary: The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Event-free Survival (EFS) and Overall Survival (OS) in: * participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 * participants whose tumors express PD-L1 CPS ≥1 * all participants The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to: * EFS in participants whose tumors express PD-L1 CPS ≥10 * EFS in participants whose tumors express PD-L1 CPS ≥1 * EFS in all participants * OS in participants whose tumors express PD-L1 CPS ≥10 * OS in participants whose tumors express PD-L1 CPS ≥1 * OS in all participants Sponsor: Merck Sharp & Dohme LLC Intervention: pembrolizumab Start Date: 2020-02-28 Last Updated: 2023-11-27 Number of Patients: 700 Recruitment Status: RECRUITING Condition: Esophageal Squamous Cell Carcinoma (ESCC)
NCTID: NCT04822350
Title: A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA Study Summary: A multicenter ambispective (retrospective and prospective) non-interventional study of patients with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France, not impacting the treatment decision made by the treating physician and the medical management of treated patients. Sponsor: Pfizer Intervention: Avelumab Start Date: 2021-07-13 Last Updated: 2023-08-07 Number of Patients: 600 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: 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: NCT04747054
Title: Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers Study Summary: Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head & neck cancers Sponsor: UNICANCER Intervention: Pembrolizumab Start Date: 2021-12-01 Last Updated: 2023-10-13 Number of Patients: 148 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of Head and Neck
NCTID: NCT05948475
Title: Study of Tinengotinib VS. Physician’s Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma Study Summary: This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician’s Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma Sponsor: TransThera Sciences (Nanjing), Inc. Intervention: Tinengotinib 8 mg Start Date: 2023-10 Last Updated: 2023-10-26 Number of Patients: 200 Recruitment Status: NOT_YET_RECRUITING Condition: Cholangiocarcinoma
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: NCT03644186
Title: To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH) Study Summary: This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade. Sponsor: ETOP IBCSG Partners Foundation Intervention: Paclitaxel Start Date: 2019-04-16 Last Updated: 2023-07-25 Number of Patients: 144 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: 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: NCT03924856
Title: Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866) Study Summary: A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-06-13 Last Updated: 2023-11-02 Number of Patients: 907 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Bladder Cancer
NCTID: 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: NCT03571633
Title: Impact of Pegfilgrastim on Trastuzumab Anti-tumor Effect and ADCC in Operable HER2+ Breast Cancer Breast Cancer Study Summary: First preclinical data suggest that pegfilgrastim could constitute a potent adjuvant for immunotherapy with mAb possessing ADCC/ADCP properties as trastuzumab. Combined treatment of pegfilgrastim and trastuzumab should translate into an increased rate of pathological clinical response. Therefore the investigators’ proposal is to evaluate the clinical and biological impact of pegfilgrastim in combination with trastuzumab + paclitaxel in HER2-positive early stage breast cancer patients. Breastimmune02 is a multicenter, randomized, open-label, Phase II trial. Operable HER2+ breast cancer patients previously treated with 4 cycles of standard adriamycine/cyclophosphamide (AC) chemotherapy will be randomized (1:1) to receive in the neoadjuvant setting:Arm A: weekly paclitaxel + trastuzumab (every 3 weeks, Q3W) + pegfilgrastim (Q3W) versus Arm B: weekly paclitaxel + trastuzumab (Q3W).Stratification criteria will be: cN0 versus cN1. Sponsor: Centre Leon Berard Intervention: Trastuzumab + Paclitaxel Start Date: 2018-08-06 Last Updated: 2023-01-10 Number of Patients: 90 Recruitment Status: RECRUITING Condition: HER2-positive Breast Cancer
NCTID: NCT03248492
Title: A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) Study Summary: Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-8201a Start Date: 2017-08-25 Last Updated: 2023-11-15 Number of Patients: 253 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: 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: NCT02866955
Title: Evaluation of the Efficacy of Estramustine in Patient With Breast Cancer Progression After Treatment With Aromatase Inhibitor. Study Summary: Despite advances in early detection and treatment strategy, about 25 to 40% of patients treated for breast cancer develop metastasis. Some patients are in a therapeutic impasse situation. It is therefore necessary to consider all possible options. The Estramustine showed encouraging results in the treatment of metastatic breast cancer. Given the clinical data, the answer rate of Estramustine and its impact on progression free survival deserve to be studied in earlier clinical situation. This Phase II study evaluated the efficacy of Estramustine in women with breast cancer and metastates, already treated with aromatase inhibitors and for whom this treatment has failed. Sponsor: Institut de Cancérologie de Lorraine Intervention: Estramustine Start Date: 2011-06-15 Last Updated: 2020-03-09 Number of Patients: 100 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02438007
Title: A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC Study Summary: The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC). Sponsor: LTN PHARMACEUTICALS, INC. Intervention: Galeterone Start Date: 2015-06 Last Updated: 2023-03-15 Number of Patients: 953 Recruitment Status: TERMINATED Condition: Prostate Cancer
NCTID: 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: NCT02184416
Title: Study Of The Impact Of Inlyta In 2nd Line On The Treatment Outcomes Of mRCC Patients Treated With Sutent In 1st Line In The Real Life Setting Study Summary: This is an international, multi-centre, prospective (partly retrospective), observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated with sunitinib in first line and/or receiving axitinib in second line post sunitinib. The study is designed to enroll approximately 750 patients over the course of an enrollment period of approximately 36 months. Sponsor: Pfizer Intervention: observational Start Date: 2014-10-31 Last Updated: 2023-05-01 Number of Patients: 573 Recruitment Status: COMPLETED Condition: Metastatic Renal Cell Carcinoma (mRCC)
NCTID: NCT03879109
Title: Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer Study Summary: GRECCAR 15 is focused on Locally Recurrent Rectal Cancer (LRRC) for patients with previous pelvic radiotherapy for the primary rectal cancer. This situation leads to a 20% higher risk of non-curative resection for the LRRC management (R1 status) impacting significantly the overall survival. The widespread use of neoadjuvant radiotherapy for primary rectal cancer introduces this new problem: the treatment of LRRC in previously irradiated area. The objective of GRECCAR 15 is to assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC. Sponsor: University Hospital, Bordeaux Intervention: Chemotherapy FOLFIRINOX, 6 cycles Start Date: 2019-07-08 Last Updated: 2023-01-26 Number of Patients: 58 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Rectal Cancer
NCTID: NCT04348045
Title: Phase II Study to Evaluate MAintenance Therapy With Olaparib or Selumetinib Plus Durvalumab According to BRCAness and KRAS Somatic Status Personalized in Metastatic Pancreatic Adenocarcinoma Patients Study Summary: MAZEPPA is open-label, phase II study to assess the efficacy of a genomic-driven maintenance therapy in terms of PFS in Pancreatic ductal adenocarcinoma (PDAC) patients with disease controlled after 4 months of mFOLFIRINOX chemotherapy as following: Patients with a BRCAness somatic profile: olaparib Arm A. Patients with no BRCAness profile and with KRAS mutation randomization between durvalumab plus selumetinib Arm B, versus FOLFIRI Arm C. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: Arm A - Olaparib Start Date: 2020-12-07 Last Updated: 2023-03-07 Number of Patients: 307 Recruitment Status: RECRUITING Condition: Metastatic Pancreatic Adenocarcinoma
NCTID: NCT00483782
Title: Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Newly Diagnosed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and paclitaxel alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab to see how well they work compared with carboplatin and paclitaxel alone in treating patients with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. Sponsor: Medical Research Council Intervention: bevacizumab Start Date: 2006-04 Last Updated: 2013-08-12 Number of Patients: 1520 Recruitment Status: COMPLETED Condition: Fallopian Tube Cancer
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: NCT04109326
Title: Effect of a Program of Physical Activity and Nutritional Therapeutic Education in Breast Cancer Patients Study Summary: This multicenter randomized controlled trial aims to evaluate the effect of a tailored program of physical activity and nutritional therapeutic education on clinical, psychological and sociological factors in breast cancer patients undergoing adjuvant treatment. Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: APAD Start Date: 2013-05-15 Last Updated: 2019-09-30 Number of Patients: 360 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03350126
Title: iRECIST Evaluation’s Relevance for DCR in MMR/MSI Metastatic Colorectal Cancer Patients on Nivolumab and Ipilimumab Study Summary: This is a non-randomized study, open label phase II study. The purpose of this study is to evaluate disease control rate (DCR) by RECIST and iRECIST at 12 weeks. Evaluation of RECIST and iRECIST will be done in each center in order to choose the optimal therapy (Assessment by Investigators). A centralized evaluation of RECIST and iRECIST, will be organized in Saint-Antoine. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: Ipilimumab 200 MG in 40 ML Injection Start Date: 2017-12-04 Last Updated: 2023-09-28 Number of Patients: 57 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Cancer Colorectal
NCTID: NCT03959293
Title: Clinical Trial Evaluating FOLFIRI + Durvalumab vs FOLFIRI + Durvalumab and Tremelimumab in Second-line Treatment of Patients With Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma Study Summary: Gastric adenocarcinoma is the 4th most frequent cancer and the 2nd leading cause of cancer mortality. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone). Second-line chemotherapy-based treatment improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012). Based on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible. Preliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) ± ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm. Others anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. The present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial. Sponsor: Federation Francophone de Cancerologie Digestive Intervention: Durvalumab Start Date: 2019-07-17 Last Updated: 2023-07-12 Number of Patients: 107 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Gastric Adenocarcinoma
NCTID: NCT03838263
Title: Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer Study Summary: The aim of this research is to study the feasibility of neoadjuvant treatment before chemoradiation in “high risk” HPV-driven Oropharynx cancer Sponsor: UNICANCER Intervention: Nivolumab Start Date: 2019-07-25 Last Updated: 2023-05-11 Number of Patients: 62 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Oropharynx Cancer
NCTID: NCT03498716
Title: A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator’s choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator’s choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer) Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2018-08-02 Last Updated: 2023-09-15 Number of Patients: 2203 Recruitment Status: COMPLETED Condition: Triple Negative Breast Cancer
NCTID: NCT03871816
Title: A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer Study Summary: The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair gene defects in a population of men with metastatic Prostate Cancer (PC) and to use the reported DNA-repair gene defects to assess biomarker eligibility for niraparib interventional studies. Sponsor: Janssen Research & Development, LLC Intervention: Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis Start Date: 2019-04-22 Last Updated: 2023-01-18 Number of Patients: 14532 Recruitment Status: COMPLETED Condition: Metastatic Prostate Cancer
NCTID: NCT04884282
Title: Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED) Study Summary: This is a phase II, non-comparative, randomized study assessing combination of Tedopi with docetaxel or with nivolumab in NSCLC patients failing after first- line chemoimmunotherapy. In this non-comparative study, the standard arm (arm C) will serve as a calibration arm. All NSCLC patients candidate for second- line therapy are considered eligible for the study if they are HLA-A2+ and if they progressed after at least 4 cycles of previous first-line chemo-immunotherapy. After evaluation of all inclusion and exclusion criteria and after informed consent signature, all eligible patients will be treated with Tedopi plus docetaxel (arm A) or Tedopi plus nivolumab (arm B) or docetaxel as single agent (arm C- standard arm). Docetaxel therapy will be given until disease progression, unacceptable toxicity or patient refusal, and up to maximum 6 cycles. Tedopi or nivolumab will be given until disease progression, unacceptable toxicity or patient refusal. Sponsor: Fondazione Ricerca Traslazionale Intervention: Tedopi Start Date: 2021-10-12 Last Updated: 2023-09-18 Number of Patients: 105 Recruitment Status: RECRUITING Condition: Metastatic Non Small Cell Lung Cancer
NCTID: NCT05132582
Title: A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer Study Summary: This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer. Sponsor: Seagen Inc. Intervention: Tucatinib Start Date: 2022-03-07 Last Updated: 2023-11-21 Number of Patients: 650 Recruitment Status: RECRUITING Condition: HER2 Positive Breast Cancer
NCTID: NCT02404363
Title: Safety and Efficacy of Clopidogrel in Locally Advanced and Metastatic Pancreatic Adenocarcinoma Treated With Chemotherapy Study Summary: Clopidogrel has been shown to slow down tumor progression in orthoptic pancreatic murine tumor. In a pilot study, the rate of microparticles was correlated with response rate of pancreatic adenocarcinoma. The aim of the study is; * to compare the phenotypes of coagulation, the tumor progression and metastasis formation with and without clopidogrel treatment in association with chemotherapy in advanced pancreatic cancer patients * to correlate the decrease of microparticles levels after one month of chemotherapy with tumor response (ancillary study) Sponsor: Assistance Publique - Hôpitaux de Paris Intervention: Clopidogrel Start Date: 2016-01-11 Last Updated: 2019-07-25 Number of Patients: 39 Recruitment Status: TERMINATED Condition: Locally Advanced Pancreatic Cancer
NCTID: NCT03834493
Title: Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641) Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-07-28 Last Updated: 2023-06-15 Number of Patients: 1244 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostatic Neoplasms
NCTID: 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: NCT02008227
Title: A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy Study Summary: This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 <math display="block">anti-PD-L1</math> antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2014-03-11 Last Updated: 2019-12-20 Number of Patients: 1225 Recruitment Status: COMPLETED Condition: Non-Squamous Non-Small Cell Lung 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: 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: NCT00006120
Title: Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: docetaxel Start Date: 2000-05 Last Updated: 2008-07-24 Number of Patients: NA Recruitment Status: UNKNOWN Condition: Breast Cancer
NCTID: NCT00077220
Title: Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in 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. It is not yet known whether giving chemotherapy together with radiation therapy is more effective with or without adjuvant chemotherapy in treating unresectable stage II or stage III non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying giving paclitaxel, carboplatin, and radiation therapy together with adjuvant paclitaxel and carboplatin to see how well it works compared to giving paclitaxel, carboplatin, and radiation therapy alone in treating patients with unresectable stage II or stage III non-small cell lung cancer. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: carboplatin Start Date: 2002-06 Last Updated: 2009-02-09 Number of Patients: NA Recruitment Status: UNKNOWN Condition: Lung Cancer
NCTID: NCT01565109
Title: NESC: Neoadjuvant Treatment Of Gastric Adenocarcinoma Study Summary: It is estimated to 7300 the number of new cases of gastric cancer each year in France. According to a randomized trial comparing 3 cycles of ECF (epirubicin, cisplatin, 5FU) administered before surgery and 3 cycles after surgery with surgery alone in adenocarcinoma of the stomach and lower esophagus, clinical and experimental data are the neoadjuvant chemotherapy is a new standard treatment for operable gastric cancer. This treatment with a median survival of more than 3 years to obtain a hazard ratio of 0.75 in favor of chemotherapy arm (p = 0.009). The 5-year survival being 36% for patients treated with chemotherapy versus 23% for surgery alone. Progression-free survival was also significantly prolonged with a hazard ratio of 0.66. The proposed clinical study by Ajani et al shows that the combination of Docetaxel with the schema Cisplatin - 5FU provides greater clinical benefit and induces to consider the triple combination as a reference treatment in metastatic gastric cancer in patients under 65 years. Preoperative radiochemotherapy is expected to increase the rate of curative resections, reduce gastrointestinal and hematologic toxicity. Two studies evaluating the feasibility of preoperative RTCT in operable gastric adenocarcinoma with continuous 5GU (+ or - paclitaxel) and 45 Gy are available and the combination 5FU oxaliplatin has been assessed in the esophagus and rectum tumors. The NESC study, Phase II, proposes the following schema: 2 cycles of chemotherapy with Docetaxel - Cisplatin - 5FU then preoperative chemoradiation with oxaliplatin - continuous 5FU and radiotherapy in locally advanced gastric adenocarcinoma stage III and IV non-metastatic administered before surgery. Sponsor: Institut Sainte Catherine Intervention: Docetaxel - Cisplatine - 5FU Start Date: 2009-03 Last Updated: 2012-12-21 Number of Patients: 34 Recruitment Status: UNKNOWN Condition: Gastric Adenocarcinoma
NCTID: NCT02425891
Title: A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130) Study Summary: This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody Start Date: 2015-06-23 Last Updated: 2022-07-19 Number of Patients: 902 Recruitment Status: COMPLETED Condition: Triple Negative Breast Cancer
NCTID: NCT02355379
Title: Randomised Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over Study Summary: Colorectal cancer occurs mainly in elderly patients. Recent estimation showed that in France more than 50% of the patients diagnosed with a colorectal cancer are 70 years old or more. Adjuvant chemotherapy has demonstrated a benefit on disease-free survival and overall survival after a stage III colon cancer resection. Nevertheless adjuvant chemotherapy is poorly used in elderly patients. Prognostic improvement with chemotherapy based on 5FU is suggested by a post-hoc analysis of randomized prospective clinical trial. But elderly patients in this study were highly selected and patients older than 80 represented only 0.7% of the total population. Thus, there is still a concern about the benefit of adjuvant 5FU-based chemotherapy in very elderly unselected patients. The recommended treatment for stage III adjuvant chemotherapy is a combination of fuoropyrimidine and oxaliplatin. Nevertheless oxaliplatin did not demonstrated survival advantage in elderly patients. Altogether there are still two matters of debate: * First, is there a benefit of fluoropyrimidine-based adjuvant chemotherapy for unfit elderly patients? * Second, is there a benefit of oxaliplatin-based adjuvant chemotherapy for fit elderly patients? The aim of this randomized phase III study is to evaluate the benefit for disease-free survival of adjuvant chemotherapy in elderly patient and which chemotherapy. The elderly patient population will be dichotomized into two groups according to physician’s choice after a multidisciplinary evaluation involving a geriatrician, with two different randomization assignments. The patients with an expected life-expectancy below 4 years according Lee score are excluded of this study. Some biological tumour abnormalities are more frequently observed in elderly (i.e. mismatch repair deficiency), therefore an evaluation of specific biological prognostic factors is needed in elderly population. Sponsor: Federation Francophone de Cancerologie Digestive Intervention: LV5FU2 or capectitabine Start Date: 2015-01 Last Updated: 2023-08-18 Number of Patients: 774 Recruitment Status: RECRUITING Condition: Colonic Adenocarcinoma
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: NCT01994239
Title: Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy Study Summary: The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy. Sponsor: UNICANCER Intervention: Degarelix Start Date: 2012-12 Last Updated: 2022-05-12 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Adenocarcinoma of Prostate
NCTID: NCT02663908
Title: A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease Study Summary: The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in subjects with prostate cancer and cardiovascular disease. Sponsor: Ferring Pharmaceuticals Intervention: Degarelix Start Date: 2016-04-19 Last Updated: 2022-06-29 Number of Patients: 545 Recruitment Status: TERMINATED Condition: Prostate Cancer
NCTID: NCT05007106
Title: MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Study Summary: The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Co-Formulation Start Date: 2021-09-16 Last Updated: 2023-11-24 Number of Patients: 610 Recruitment Status: RECRUITING Condition: Uterine Cervical Neoplasms
NCTID: NCT03901339
Title: Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician’s Choice in Participants With HR+/HER2- Metastatic Breast Cancer Study Summary: The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician’s choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2019-05-08 Last Updated: 2023-11-18 Number of Patients: 543 Recruitment Status: COMPLETED Condition: Metastatic Breast 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: NCT00303771
Title: Combination Chemotherapy as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery Study Summary: RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) in different doses or combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer. PURPOSE: This randomized clinical trial is studying how well fluorouracil works together with leucovorin with or without irinotecan in treating older patients with metastatic colorectal cancer . Sponsor: Federation Francophone de Cancerologie Digestive Intervention: fluorouracil Start Date: 2003-06 Last Updated: 2016-05-30 Number of Patients: 282 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT01966471
Title: A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer Study Summary: This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane. Sponsor: Hoffmann-La Roche Intervention: Trastuzumab Emtansine Start Date: 2014-01-31 Last Updated: 2022-06-14 Number of Patients: 1846 Recruitment Status: COMPLETED Condition: Breast Cancer
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: NCT03713593
Title: Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002) Study Summary: The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants. The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: lenvatinib Start Date: 2018-12-31 Last Updated: 2023-07-24 Number of Patients: 794 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Hepatocellular
NCTID: NCT02273375
Title: Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC Study Summary: The purpose of this study is to find out whether it is better to receive a new drug, MEDI4736, or better to receive no further treatment after surgery (and possibly chemotherapy) for lung cancer. Sponsor: Canadian Cancer Trials Group Intervention: MEDI4736 Start Date: 2015-02-24 Last Updated: 2023-10-27 Number of Patients: 1415 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT05514054
Title: A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer Study Summary: The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. Sponsor: Eli Lilly and Company Intervention: Imlunestrant Start Date: 2022-10-04 Last Updated: 2023-10-24 Number of Patients: 6000 Recruitment Status: RECRUITING Condition: Breast Neoplasms
NCTID: NCT03519295
Title: A Study of mDCF in Combination or Not With Atezolizumab in Advanced Squamous Cell Anal Carcinoma Study Summary: SCARCE is a non-comparative randomized, 2:1 phase II study. The purpose of this study is to assess the progression-free survival rate at 12 months. (evaluation according with RECISTv1.1 criteria). For all patients, CT scan will be planned at baseline, and every 8 weeks until 12 months from randomization (or disease progression), and every 12 weeks thereafter. PET scan will be performed at baseline, at the end of mDCF treatment, and at 12 months after randomization (in absence of disease progression). CT scan and PET scan will be collected for a centralized review. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: MPDL3280A Start Date: 2018-07-22 Last Updated: 2023-09-28 Number of Patients: 99 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Anal Cancer
NCTID: NCT02268695
Title: Platinum-Cetuximab Combined With Docetaxel or With 5FU in Patients With Recurrent/Metastatic HNSCC Study Summary: This study evaluates the efficacy of the new docetaxel-cisplatin-cetuximab regimen (TPEx) versus the standard platinum-5FU-cetuximab EXTREME regimen as a first-line treatment in recurrent and/or metastatic HNSCC. Half of patients will be treated by TPEx regimen, while the other half will be treated by EXTREME regimen. Sponsor: Groupe Oncologie Radiotherapie Tete et Cou Intervention: Cisplatin Start Date: 2014-10-10 Last Updated: 2022-08-23 Number of Patients: 541 Recruitment Status: COMPLETED Condition: Head and Neck Squamous Cell Carcinoma
NCTID: NCT00722553
Title: Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder Study Summary: The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body). Sponsor: Acrotech Biopharma Inc. Intervention: Pralatrexate Injection Start Date: 2008-07 Last Updated: 2019-12-17 Number of Patients: 30 Recruitment Status: COMPLETED Condition: Carcinoma, Transitional Cell
NCTID: NCT02885753
Title: Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver Study Summary: Colorectal cancer is the 3rd most common cancer in France and the 2nd cause of death from cancer. Between 30 to 60% of patients develop limited or predominant liver metastases. Surgical resection of these metastases, only curative treatment is not immediately possible in 10-15% of cases. In unresectable patients, current palliative treatments are based on systemic chemotherapy associated or not with the targeted therapies (anti-EGFR (panitumumab), anti-VEGF (bevacizumab)). In this patient population, special attention was paid to intensified treatment regimens in order to improve their efficiency and improving the tumoral response rate, the intensity of the response and its earliness correlate with improved overall and progression-free survival. The intra-arterial use of oxaliplatin coupled with IV chemotherapy has yielded OR levels of 64% in patients having survived one or more lines of chemotherapy IV and 62% in patients who have progressed on oxaliplatin IV. In addition, the HIA administration of oxaliplatin limits systemic and especially neurological toxicities, thanks to a greater hepatic clearance. In conclusion, the combination of systemic chemotherapy, targeted therapy and HIAC with oxaliplatin has showed promising efficacy results associated with good tolerance from the first line onwards. Indeed, we can expect from the Phase II recent data, a control rate close to 100%, with high response rates associated with early maturity and depth responses as well as prolonged survival. However, to date, in the absence of randomized trial testing this combination, this strategy does not have sufficient evidence to be integrated in our routine practices, and HIAC remains limited to a few expert centers in treatment catch-up. Sponsor: Federation Francophone de Cancerologie Digestive Intervention: Oxaliplatin intravenous Start Date: 2016-12 Last Updated: 2023-08-18 Number of Patients: 348 Recruitment Status: RECRUITING Condition: Colorectal Neoplasms
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: NCT03529110
Title: DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] Study Summary: This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane. Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan (T-DXd) Start Date: 2018-08-09 Last Updated: 2023-02-09 Number of Patients: 524 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT01313377
Title: Gemcitabine Hydrochloride and Oxaliplatin or Observation in Treating Patients With Biliary Tract Cancer That Has Been Removed by Surgery Study Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Observation is watching a patient’s condition but not giving treatment until symptoms appear. It is not yet known whether giving gemcitabine hydrochloride together with oxaliplatin is more effective than observation in treating patients with biliary tract cancer that has been removed by surgery. PURPOSE: This randomized phase III trial is studying giving gemcitabine hydrochloride together with oxaliplatin to see how well it works compared with observation in treating patients with biliary tract cancer that has been removed by surgery. Sponsor: UNICANCER Intervention: gemcitabine hydrochloride Start Date: 2009-07 Last Updated: 2017-01-25 Number of Patients: 190 Recruitment Status: COMPLETED Condition: Extrahepatic Bile Duct Cancer
NCTID: NCT00268333
Title: Combination Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Colorectal Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with recurrent metastatic colorectal cancer. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: fluorouracil Start Date: 2005-08 Last Updated: 2009-02-09 Number of Patients: 39 Recruitment Status: COMPLETED Condition: Colorectal Cancer
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: NCT05152147
Title: A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers Study Summary: This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic). Sponsor: Jazz Pharmaceuticals Intervention: Zanidatamab Start Date: 2021-12-02 Last Updated: 2023-11-18 Number of Patients: 714 Recruitment Status: RECRUITING Condition: Gastric Neoplasms
NCTID: NCT00227747
Title: Radiation Therapy and Capecitabine With or Without Oxaliplatin in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Rectal Cancer Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy together with combination chemotherapy before surgery may shrink the tumor so it can be removed. It is not yet known whether giving radiation therapy together with capecitabine is more effective with or without oxaliplatin before surgery in treating rectal cancer. PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and oxaliplatin to see how well they work compared to radiation therapy and capecitabine in treating patients who are undergoing surgery for stage II or stage III rectal cancer. Sponsor: UNICANCER Intervention: capecitabine Start Date: 2005-11-08 Last Updated: 2021-02-17 Number of Patients: 598 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT05078047
Title: Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients With Metastatic Cancer in Response After 6 Months of Standard IO Study Summary: Immunotherapy (IO), such as treatment with anti-PD-1, PD-L1, or CTLA-4 inhibitors, is a rapidly expanding treatment for multiple metastatic cancers with improved survival for certain cancers. However, the optimal duration of immunotherapies is currently unknown. Our hypothesis is that a reduced dose intensity of IO could be as effective as the current standard treatment in term of prevention of the disease progression. If proved right, this study will have a positive medico-economic impact by reduction of the costs associated with the treatment and the toxicity, and an increase of the patients’ quality of life. Sponsor: UNICANCER Intervention: Reduced dose intensity of IO Start Date: 2022-03-08 Last Updated: 2023-08-30 Number of Patients: 646 Recruitment Status: RECRUITING Condition: Lung Cancer Metastatic
NCTID: NCT04790253
Title: PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study) Study Summary: In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Prophylactic cranial irradiation Start Date: 2022-10-27 Last Updated: 2023-11-03 Number of Patients: 600 Recruitment Status: RECRUITING Condition: Limited Stage Small Cell Lung Cancer
NCTID: NCT02083653
Title: Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer Study Summary: This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs). Sponsor: Symphogen A/S Intervention: Sym004 (12 mg/kg) Start Date: 2014-03-06 Last Updated: 2019-04-16 Number of Patients: 254 Recruitment Status: COMPLETED Condition: Metastatic Colorectal Cancer
NCTID: NCT03734029
Title: Trastuzumab Deruxtecan (DS-8201a) Versus Investigator’s Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] Study Summary: This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants’ cancer: * Cannot be removed by an operation * Has spread to other parts of the body Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan (DS-8201a) Start Date: 2018-12-27 Last Updated: 2023-06-15 Number of Patients: 557 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT01325961
Title: Medico-economic Evaluation Comparing Intensity-Modulated Radiation Therapy (IMRT) Performed by Helical Tomotherapy and Dynamic Arc Therapy in Prostate, Cervical and Anal Canal Cancers Study Summary: The aim of the study is a medico-economic evaluation to estimate a cost differential between three modalities of Intensity-Modulated Radiation Therapy for cancers of the prostate, cervix and anal canal with pelvic lymph node irradiation : treatment with helical Tomotherapy and dynamic arc therapy using two different technologies: RapidArc or VMAT. Sponsor: Institut Cancerologie de l’Ouest Intervention: Intensity-Modulated Radiation Therapy Start Date: 2011-03 Last Updated: 2021-05-24 Number of Patients: 217 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT04933695
Title: A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment Study Summary: The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) < 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 < 1% and in a subgroup of participants with STK11 co-mutation. Sponsor: Amgen Intervention: Sotorasib Start Date: 2022-01-28 Last Updated: 2023-10-11 Number of Patients: 42 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT04961996
Title: A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician’s Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) Study Summary: This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population. Sponsor: Hoffmann-La Roche Intervention: Giredestrant Start Date: 2021-08-27 Last Updated: 2023-11-18 Number of Patients: 4200 Recruitment Status: RECRUITING Condition: Early Breast Cancer
NCTID: NCT04233021
Title: Study of Osimertinib in Patients With a Lung Cancer With Brain or Leptomeningeal Metastases With EGFR Mutation Study Summary: Treatment of non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutation is mainly based on tyrosine kinase inhibitors (TKIs) targeting EGFR. 1st or 2nd generation inhibitors have been shown to be superior to chemotherapy in terms of Progression-Free Survival (PFS) when used as 1st line treatment. In case of progression at several metastatic sites, systemic treatment will be considered and will depend on the presence of the TKI resistance mutation, the T790M mutation. In the presence of the T790M mutation, osimertinib is superior to chemotherapy in terms of progression-free survival, while in the absence of the T790M mutation, platinum salt chemotherapy is recommended. In case of local progression, treatment of the site in progression by radiotherapy and/or surgery is considered. As these local treatments can cause long-term adverse effects, systemic treatments are increasingly being considered in this indication. Brain and leptomeningeal metastases are the most frequent isolated site of progression in EGFR mutated patients treated with TKI. The high frequency of isolated cerebral and leptomeningeal progression is a consequence of the lower diffusion of 1st and 2nd generation TKIs in the central nervous system (CNS). Osimertinib is a 3rd generation TKI that has the particularity of overcoming the T790M mutation and having greater brain penetration than 1st or 2nd generation TKIs, which could make it an attractive therapeutic option in the event of brain progression or leptomeningeal progression. However, its efficacy in patients with cerebral or leptomeningeal metastases is still poorly understood. Sponsor: Intergroupe Francophone de Cancerologie Thoracique Intervention: Osimertinib Start Date: 2020-07-16 Last Updated: 2023-07-27 Number of Patients: 57 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non Small Cell Lung Cancer Metastatic
NCTID: NCT03374488
Title: Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma Study Summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease. Sponsor: Incyte Corporation Intervention: Pembrolizumab Start Date: 2017-12-22 Last Updated: 2021-11-30 Number of Patients: 84 Recruitment Status: COMPLETED Condition: UC (Urothelial Cancer)
NCTID: NCT02291289
Title: A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) Study Summary: This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years. Sponsor: Hoffmann-La Roche Intervention: Cetuximab Start Date: 2015-04-17 Last Updated: 2021-05-26 Number of Patients: 609 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT04719988
Title: Anti-PD-1 and mDCF Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma. Study Summary: Squamous cell carcinoma of the anus (SCCA) is a rare cancer, however its incidence is increasing worldwide. SCCA is mostly induced by human papillomavirus (HPV) infections (high-risk types such as HPV-16 and -18) and HPV-related oncoproteins (E6 and E7) are expressed in more than 90% of cases. T stage and N stage are recognized prognostic factors for local and/or distant recurrence in SCCA patients treated by CRT. In fact, ≥T3 or ≥N1 anal cancers are associated with as high as 50% disease recurrence rate at 2 years. Since 1996 when concomitant radiotherapy and MMC (mytomicin C) and 5-FU-based chemotherapy demonstrated superiority to radiotherapy alone, no significant progress has been achieved in patients with locally advanced SCCA. Still, phase III study by James et al. reported in 2013 showed that prognosis of SCCA patients treated with this regimen can be improved probably due to a better tumor classification, more precise radiological methods, known as “Will Rogers phenomenon”. Based on the above, investigators have designed this phase II trial assessing the feasibility and efficacy of Ezabenlimab (BI 754091) and mDCF chemotherapy combination followed by: * standard chemoradiotherapy in case of low response to induction treatment (<30% by RECIST criteria) or * additional 2 cycles of mDCF and 1 cycle of Ezabenlimab (BI 754091) followed by hypofractionated radiotherapy in case of high response (≥ 30% by RECIST criteria) in SCCA patients with high-risk locally advanced (stage III) disease. In summary, the first innovative aspect of this research program is to provide a valuable proof of concept study evaluating the feasibility to combine radiotherapy, chemotherapies (docetaxel, cisplatin and 5-fluorouracil) and Ezabenlimab (BI 754091) in patients with stage III squamous cell anal carcinoma. INTERACT-ION study will provide evidence that Ezabenlimab (BI 754091) acts in synergy with mDCF to improve complete response rate, and both with hypofractionated radiotherapy to improve the disease-free survival enhancing TH1 and CD8 T cell immunity. Sponsor: Centre Hospitalier Universitaire de Besancon Intervention: Blood sample collection Start Date: 2022-01-04 Last Updated: 2023-05-26 Number of Patients: 55 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of the Anus Stage III
NCTID: NCT00072462
Title: Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ Study Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ. PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ. Sponsor: Queen Mary University of London Intervention: tamoxifen citrate Start Date: 2003-09 Last Updated: 2021-10-06 Number of Patients: 2980 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02490488
Title: Masitinib in Combination With Gemcitabine in Advanced/Metastatic Epithelial Ovarian Cancer Patients Study Summary: The objective is to evaluate the efficacy and safety of masitinib in combination with gemcitabine in refractory ovarian cancer patients. Sponsor: AB Science Intervention: Masitinib Start Date: 2014-04 Last Updated: 2020-12-08 Number of Patients: 248 Recruitment Status: COMPLETED 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: NCT01772472
Title: A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) Study Summary: This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated. Sponsor: Hoffmann-La Roche Intervention: trastuzumab Start Date: 2013-04-03 Last Updated: 2023-11-13 Number of Patients: 1487 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT04873362
Title: A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy Study Summary: This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2021-05-04 Last Updated: 2023-11-13 Number of Patients: 1700 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT02980510
Title: Comparison FOLFIRINOX Panitumumab vs mFOLFOX6 Panitumumab in RAS/B-RAF Wild-type Metastatic Colorectal Cancer Patients Study Summary: National trial, multicenter, randomized, phase II assessing FOLFIRINOX + Panitumumab versus mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF status from circulating DNA analysis. Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab. Sponsor: UNICANCER Intervention: Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil Start Date: 2016-12 Last Updated: 2023-09-05 Number of Patients: 219 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT01910610
Title: Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer Study Summary: STRATEGIC-1 is a study designed to determine the best sequence of therapy in patients with metastatic colorectal cancer. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: FOLFIRI-cetuximab Start Date: 2013-10-30 Last Updated: 2021-06-16 Number of Patients: 474 Recruitment Status: UNKNOWN Condition: Colorectal Cancer Metastatic
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: NCT05346848
Title: Randomized Phase II Trial on Short Term Darolutamide Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer Study Summary: Randomized non-comparative phase II trial to assess the preliminary signs of antitumor activity of darolutamide plus radiation therapy in patients with unfavorable intermediate risk prostate cancer. Sponsor: Institut Bergonié Intervention: Association of darolutamide and EBRT Start Date: 2023-02-24 Last Updated: 2023-03-03 Number of Patients: 62 Recruitment Status: RECRUITING Condition: Prostate Cancer
NCTID: NCT03630666
Title: Comparison of Intermittent Androgen Deprivation Therapy With or Without Irradiation Recovery in Prostate Cancer Patients Study Summary: Metastatic prostate cancer has traditionally been regarded as an incurable dissemination of disease, and treatment is focused on delaying progression rather than eliminating all tumor burden. Local therapies, and specifically radiotherapy, have been directed at quality of life endpoints and not at improving survival. However, advances in imaging and systemic therapy have identified a population of ‘oligometastatic’ patients who have a lower burden of metastatic disease (usually ≤5 lesions), who may present an exception. This condition is hypothesized to occupy the hinterland between incurable metastatic disease and locoregional disease, where micrometastatic disease is assumed to exist and yet remain eradicable. Oligometastases can be detected using standard imaging but the sensitivity of these exams is very low for patients with a PSA below 10 ng/ml. In France, FCH PET imaging is now routinely available in a large majority of cancer centres. More recently, PSMA PET imaging has been developed. Since most oligometastases are now discovered at a time when conventional imaging is unable to detect metastases, we must rely on the literature regarding purely biochemically-relapsing prostate cancer patients. Three strategies have been explored: (i) observation until symptoms develop, (ii) early intermittent Androgen Deprivation Therapy (IADT) and (iii) continuous Androgen Deprivation Therapy (ADT). Recent data suggest that, of the three strategies, early intermittent ADT was superior in term of overall survival to observation in controlling metastatic prostate cancer, and this effect was similar in the biochemically-relapsing prostate cancer patient population. This phase III study will explore the role of salvage pelvic IG-IMRT combined with intermittent ADT (IADT) in pelvic oligometastatic patients in prolonging the first failure-free interval between the first and the second intermittent ADT courses. Sponsor: Institut Cancerologie de l’Ouest Intervention: IADT Start Date: 2018-12-04 Last Updated: 2023-08-01 Number of Patients: 256 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer
NCTID: NCT03353831
Title: Atezolizumab With Bevacizumab and Chemotherapy vs Bevacizumab and Chemotherapy in Early Relapse Ovarian Cancer Study Summary: This is a phase III, randomized, partially blinded, multicenter trial to evaluate the efficacy and safety of atezolizumab plus bevacizumab and chemotherapy compared to placebo plus bevacizumab and chemotherapy in patients with recurrent ovarian-, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after platinum based chemotherapy or 3rd relapse. Sponsor: AGO Research GmbH Intervention: Bevacizumab Start Date: 2018-09-11 Last Updated: 2022-07-27 Number of Patients: 550 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Recurrent Ovarian Carcinoma
NCTID: NCT03820830
Title: Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer Study Summary: POLAR is a phase III clinical trial, which will test the safety and efficacy of an investigational combination of drugs to learn whether the combination of drugs works for a specific cancer. Palbociclib (Ibrance®) is the name of the investigational agent, which is assessed together with standard anti-hormone therapy in this study. Palbociclib is used to treat patients with hormone receptor-positive / HER2-negative breast cancer which has spread beyond the original tumor and/or to other organs. During this study, anti-hormone therapy will consist of either a selective estrogen receptor modulator (such as tamoxifen) or an aromatase inhibitor (anastrozole, letrozole, exemestane) or fulvestrant (Faslodex®). Premenopausal women and men may also receive a drug called an LHRH (luteinizing hormone-releasing hormone) agonist by injection. It is standard of care for people with hormone receptor positive breast cancer to take anti-hormone therapy. The study doctor will determine the type of standard anti-hormone therapy that will be given during this trial. The purpose of the POLAR study is to compare the effect of using 3 years of palbociclib in combination with standard anti-hormone therapy with standard anti-hormone therapy alone and to evaluate the time until the breast cancer returns, if it does return. Sponsor: ETOP IBCSG Partners Foundation Intervention: Palbociclib 125mg Start Date: 2019-08-27 Last Updated: 2023-08-29 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Breast Cancer Recurrent
NCTID: NCT01842321
Title: Abiraterone Acetate in Molecular Apocrine Breast Cancer Study Summary: The purpose of this study is to estimate antitumour activity of abiraterone acetate in Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast Cancer. Sponsor: UNICANCER Intervention: Abiraterone Acetate Start Date: 2013-07 Last Updated: 2021-02-23 Number of Patients: 34 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00207831
Title: Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma Study Summary: RATIONALE: Drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and also as a radiosensibilisant. Radiation therapy uses high-energy x-rays to kill tumor cells. 5-fluorouracil may make tumor cells more sensitive to radiation therapy. Oral 5-fluorouracil is more convenient for ambulatory patients. Giving UFT (Tegafur and Uracil) with radiation therapy before surgery may shrink the tumor so it can be removed. PURPOSE: This phase III trial is studying how well giving UFT with radiation therapy works in treating patients who are undergoing surgery for operable rectal cancer. Sponsor: Institut Cancerologie de l’Ouest Intervention: Tegafur and Uracil Start Date: 2004-07 Last Updated: 2020-03-25 Number of Patients: 219 Recruitment Status: TERMINATED Condition: Rectal Cancer
NCTID: NCT03026166
Title: A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer Study Summary: The purpose of this study is to assess the safety and efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab and ipilimumab in participants with extensive-stage small cell lung cancer (SCLC). Sponsor: AbbVie Intervention: Ipilimumab Start Date: 2017-03-30 Last Updated: 2020-07-17 Number of Patients: 42 Recruitment Status: TERMINATED Condition: Small Cell Lung Cancer
NCTID: NCT03870919
Title: Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients Study Summary: Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic. De novo metastatic breast cancer accounts for 20% to 25% of these cases. Despite a decrease in mortality in Europe and North America due to early detection and access to treatment, breast cancer remains the 2ⁿᵈ leading cause of cancer deaths in developed countries after lung cancer and the world’s leading cause. In the ESME French national retrospective cohort (NCT03275311), the newly diagnosed estrogen receptor (ER)-positive and HER2-negative (luminal) metastatic patients had a 59.1 months overall survival (OS) for pre-menopausal women and 44.7 months for postmenopausal women. In the same cohort, the median OS was 47.4 months for de novo metastatic patients with hormone receptor (HR)-positive / HER2-negative breast cancer. The most important current treatment for metastatic breast cancer remains systemic therapy. Surgery and radiation are mainly used to treat symptoms. However, more than 15 retrospective studies have assessed the impact of locoregional treatment on relapse and OS. These studies suggested an improvement of the OS in patients with de novo metastatic breast cancer thanks to the addition of locoregional treatment to systemic therapy. Recent data from the ESME cohort suggest that patients with de novo luminal or HER2-positive metastatic breast cancer may benefit from local treatment of the primary tumor. Several prospective trials have attempted to demonstrate the benefit of locoregional treatment with mixed results. This can be explained by a limited power of statistical analysis, on the recruitment of patients with breast cancer of all types, and on a limited access to effective systemic therapies in some cases and all before the area of anti CD4/6 which is the current standard treatment in patients with HR-positive / HER2-negative luminal metastatic disease. However, guidelines indicate that a “multimodal approach, including curative locoregional treatments, should be considered”. As a result, many clinicians offer locoregional treatment of the primary tumor, especially if there is a good response to the first line of systematic treatment. Taken together, these data underscore the need for an evaluation of the value of combined therapy - endocrine therapy - CDK4/6 inhibitor and locoregional treatment - in this population of patients with newly diagnosed HR-positive / HER2-negative breast cancer. Sponsor: UNICANCER Intervention: Palbociclib Start Date: 2019-10-23 Last Updated: 2023-05-31 Number of Patients: 200 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer Stage IV
NCTID: NCT02450331
Title: A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection Study Summary: This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2015-10-05 Last Updated: 2023-06-18 Number of Patients: 809 Recruitment Status: TERMINATED Condition: Carcinoma, Transitional Cell
NCTID: NCT00275119
Title: Gemcitabine and Oxaliplatin Followed By Radiation Therapy, Fluorouracil, and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery Study Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: fluorouracil Start Date: 2003-11 Last Updated: 2009-02-09 Number of Patients: NA Recruitment Status: UNKNOWN Condition: Pancreatic Cancer
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: 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: NCT01143285
Title: Impact of Early and Active Nutritional and Dietary Management grade3 or More Toxicities Induced by Chemotherapy and Targeted Therapies Administered to Patients as First Intention for Non Surgical Metastatic Colorectal Cancer Study Summary: Description of active nutritional support: Early and active nutritional support is mainly concerned with maintaining protein and energy intake levels despite chemotherapy. A part-time nutritionist will be assigned to each research centre. She will cover active nutritional support during a one-hour consultation and assist the investigating oncologist in filling out the e-CRF data. A two-day meeting prior to the beginning of the study will enable the standardization of active nutritional support strategy across all research centres: * The nutritionist will explain the consequences of the side effects of chemotherapy on appetite levels and nutritional status. * Spontaneous oral intake and eating habits will be assessed based on a qualitative and quantitative 3-day food record. * Then the nutritionist will explain to patients how to adapt their diet (fortification, portion control etc.) according to personal preferences and dietary habits, appetite fluctuation and side effects. * A booklet containing an overview of the nutritional counsel, recipe ideas, an example of a daily menu, energy equivalence tables and specific diet and hygiene tips for each possible side effects of chemotherapy will be given to all patients. * During each consultation, patients will be weighed, appetite and food intake will be evaluated (24-hour record except for prospective 3-day record of V0, V3, V6, V9, V12, V13 and V14 consultations), chemotherapy side effects will be recorded and nutritional counsel will be adapted to each patient’s individual situation. In case of decrease in food intake and/or weight loss, a protein- and energy-rich oral supplement will be given. In both groups, if a patient exhibits signs of malnutrition (weight loss >5% over a one-month period or > 10% in total) and/or food intake less than 50% of estimated daily requirements, an oral supplement will be given after approval of the oncologist. If this measure is insufficient, artificial nutrition (enteral or parenteral) will be considered. Sponsor: Centre Hospitalier Universitaire de Nice Intervention: Early and active nutritional support. Start Date: 2010-04 Last Updated: 2016-04-25 Number of Patients: 180 Recruitment Status: COMPLETED Condition: Metastatic Colorectal Cancer
NCTID: NCT03523585
Title: DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] Study Summary: This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan Start Date: 2018-08-01 Last Updated: 2023-06-26 Number of Patients: 608 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT04241185
Title: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) Study Summary: This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-05-19 Last Updated: 2023-11-27 Number of Patients: 636 Recruitment Status: RECRUITING Condition: Urinary Bladder Neoplasms
NCTID: NCT02216786
Title: A Randomized Study of AZD2014 in Combination With Fulvestrant in Metastatic or Advanced Breast Cancer Study Summary: This is an open-label, multicentre, 4-arm randomised phase II trial of fulvestrant + AZD2014 versus fulvestrant + everolimus versus fulvestrant alone in patients with ER-positive, HER2-negative advanced or metastatic breast cancer, whose disease relapsed during treatment with (or within 12 months after discontinuation of) an AI in the adjuvant setting or progressed during treatment with an AI in the metastatic setting. Patients will be randomised (2:3:3:2) to one of the four treatment arms: * Fulvestrant * Fulvestrant + AZD2014 (continuous daily schedule) * Fulvestrant + AZD2014 (intermittent schedule - 2 days on, 5 days off) * Fulvestrant + everolimus Randomization will be stratified by the following criteria: * Measurable disease (vs. non-measurable). * Sensitivity to prior endocrine therapy (sensitive versus resistant) Sponsor: Queen Mary University of London Intervention: AZD2014 Start Date: 2014-01 Last Updated: 2020-02-25 Number of Patients: 333 Recruitment Status: UNKNOWN Condition: Estrogen Receptor Positive Breast Cancer
NCTID: NCT01997333
Title: Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer Study Summary: The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population. Sponsor: Celldex Therapeutics Intervention: CDX-011 Start Date: 2013-11 Last Updated: 2019-03-08 Number of Patients: 327 Recruitment Status: COMPLETED Condition: Metastatic gpNMB Over-expressing Triple Negative Breast Cancer
NCTID: NCT03452137
Title: A Study of Atezolizumab (Anti-Pd-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck Study Summary: This study will evaluate the efficacy and safety of atezolizumab compared with placebo as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (SCCHN) Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2018-04-03 Last Updated: 2023-09-18 Number of Patients: 406 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
NCTID: NCT05253651
Title: A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer Study Summary: This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either: * mFOLFOX6 alone, * mFOLFOX6 with bevacizumab, or * mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer. Sponsor: Seagen Inc. Intervention: tucatinib Start Date: 2022-10-24 Last Updated: 2023-11-21 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Colorectal Neoplasms
NCTID: NCT00274872
Title: Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery Study Summary: RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer. PURPOSE: This randomized phase II/III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer that cannot be removed by surgery. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: fluorouracil Start Date: 2004-01 Last Updated: 2010-02-01 Number of Patients: 600 Recruitment Status: UNKNOWN Condition: Colorectal Cancer
NCTID: NCT03869892
Title: Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy. Study Summary: The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab. Sponsor: Institut de Recherches Internationales Servier Intervention: Trifluridine/tipiracil hydrochloride (S95005) Start Date: 2019-03-21 Last Updated: 2023-11-18 Number of Patients: 856 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT03692065
Title: API-CAT STUDY for APIxaban Cancer Associated Thrombosis Study Summary: The main objective is to determine whether a low-dose regimen of apixaban (2.5 mg bid) is non inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent venous thromboembolism (VTE) in patients with active cancer who have completed at least 6 months of anticoagulant therapy for treating a documented index event of proximal deep venous thrombosis (DVT) (symptomatic or incidental) or pulmonary embolism (symptomatic or incidental). Sponsor: Assistance Publique - Hôpitaux de Paris Intervention: Apixaban 5 MG Start Date: 2018-10-11 Last Updated: 2023-09-13 Number of Patients: 1767 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cancer-associated Thrombosis
NCTID: NCT01164202
Title: Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer Study Summary: RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping anticancer drugs near the tumor. Sunitinib malate 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 chemoembolization is more effective with or without sunitinib malate in treating patients with liver cancer. PURPOSE: This randomized phase II/III trial is studying the side effects of chemoembolization of the liver and to see how well in works when given together with or without sunitinib malate in treating patients with liver cancer. Sponsor: Federation Francophone de Cancerologie Digestive Intervention: sunitinib malate Start Date: 2010-07 Last Updated: 2022-03-18 Number of Patients: 78 Recruitment Status: COMPLETED Condition: Liver Cancer
NCTID: NCT01358877
Title: A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer Study Summary: This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG). Sponsor: Hoffmann-La Roche Intervention: 5-Fluorouracil Start Date: 2011-11-08 Last Updated: 2023-10-04 Number of Patients: 4804 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
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: NCT03125902
Title: A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) Study Summary: This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 <math display="block">PD-L1</math> antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody Start Date: 2017-08-25 Last Updated: 2023-02-15 Number of Patients: 653 Recruitment Status: COMPLETED Condition: Triple-Negative 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: NCT04604132
Title: Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma Study Summary: The purpose of this study is to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel, ramucirumab, or atezolizumab in patients with HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring FGFR2 genetic aberrations (GA). Sponsor: Basilea Pharmaceutica Intervention: Derazantinib Start Date: 2020-10-06 Last Updated: 2023-02-16 Number of Patients: 47 Recruitment Status: TERMINATED Condition: Gastric Adenocarcinoma
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: NCT05089734
Title: Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Study Summary: The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy (SG) Start Date: 2021-11-17 Last Updated: 2023-06-29 Number of Patients: 580 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT02657434
Title: A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132) Study Summary: This is a randomized, Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in two phases: Induction Phase and Maintenance Phase. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2016-04-30 Last Updated: 2023-11-21 Number of Patients: 578 Recruitment Status: COMPLETED Condition: Non-Small Cell Lung Cancer
NCTID: NCT05476796
Title: Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer Study Summary: Oxaliplatin ± nivolumab in combination with trifluridine/tipiracil or 5-fluorouracile (5-FU) in frail patients with advanced, recurrent or metastatic gastric, oesophageal or gastroesophageal junction cancer. Sponsor: UNICANCER Intervention: Trifluridine/Tipiracil Start Date: 2023-06-23 Last Updated: 2023-10-16 Number of Patients: 118 Recruitment Status: RECRUITING Condition: Gastric Adenocarcinoma
NCTID: NCT02952586
Title: Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100) Study Summary: This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer. Sponsor: Pfizer Intervention: Avelumab Start Date: 2016-11-28 Last Updated: 2021-09-22 Number of Patients: 697 Recruitment Status: TERMINATED Condition: Squamous Cell Carcinoma of the Head and Neck
NCTID: NCT03765918
Title: Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689) Study Summary: This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab 200 mg Start Date: 2018-12-17 Last Updated: 2023-10-10 Number of Patients: 704 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Head and Neck Neoplasms
NCTID: NCT03656536
Title: A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma Study Summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement. Sponsor: Incyte Corporation Intervention: Pemigatinib Start Date: 2019-06-03 Last Updated: 2023-11-15 Number of Patients: 434 Recruitment Status: RECRUITING Condition: Unresectable Cholangiocarcinoma
NCTID: NCT00381901
Title: Trastuzumab for 6 Months or 1 Year in Treating Women With Nonmetastatic 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. It is not yet known whether giving trastuzumab for 6 months is as effective as giving trastuzumab for 1 year in treating patients with breast cancer. PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works when given for 6 months compared to 12 months in treating women with nonmetastatic breast cancer that can be removed by surgery. Sponsor: National Cancer Institute, France Intervention: trastuzumab Start Date: 2006-05 Last Updated: 2011-05-13 Number of Patients: 3400 Recruitment Status: COMPLETED Condition: Breast Cancer
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: NCT05805501
Title: A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (also known as RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT) and axitinib, as compared to pembrolizumab and axitinib in participants with previously untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma (ccRCC). Sponsor: Hoffmann-La Roche Intervention: Tobemstomig Start Date: 2023-04-21 Last Updated: 2023-11-14 Number of Patients: 210 Recruitment Status: RECRUITING Condition: Renal Cell Carcinoma
NCTID: NCT00002523
Title: Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed 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, giving the drugs in different ways, and combining radiation therapy and surgery with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare radiation therapy alone before surgery with radiation therapy plus fluorouracil and leucovorin before surgery, with and without fluorouracil and leucovorin after surgery in patients with rectal cancer that can be surgically removed. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: fluorouracil Start Date: 1993-04 Last Updated: 2016-09-02 Number of Patients: 1011 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT02730923
Title: Hormone Receptor Positive endometrIal Carcinoma Treated by Dual mTORC1/mTORC2 Inhibitor and Anastrozole (VICTORIA) Study Summary: The investigators hypothesize that the dual inhibition of mTORC1/mTORC2 by AZD2014 combined with inhibition of aromatase enzyme by anastrozole will act synergistically and may be an interesting therapeutic option for endometrial cancer with a manageable toxicity profile. The investigators proposal is to conduct a multicenter, 2-step, randomized, Phase I/II trial to evaluate the safety and efficacy of a combination treatment associating anastrozole to AZD2014 in advanced endometrial cancer patients. The study is divided in 2 steps : * A safety run-in phase aiming to evaluate the safety of the proposed combination AZD2014 + anastrozole (Arm A) versus anastrozole alone (Arm B). No dose escalation is scheduled (doses are based on maximum tolerated dose (MTD) defined for AZD2014 and the summary of product characteristics (SPC) of anastrozole). However, dose de-escalation for AZD2014 will be applied in case of toxicity. * A two-stage randomized Phase II part aiming to evaluate the clinical benefit of the AZD2014 + anastrozole (Arm A) combination therapy versus anastrozole (Arm B). Sponsor: Centre Leon Berard Intervention: AZD2014 Start Date: 2016-04 Last Updated: 2023-09-13 Number of Patients: 72 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Endometrial Carcinoma
NCTID: NCT03730558
Title: ZETA : Prospective Observational Study Study Summary: Primary objective * Evaluate the efficacy in terms of progression-free survival (PFS) of aflibercept in combination with FOLFIRI in patients treated routinely for metastatic colorectal cancer (mCRC) after failure of treatment with oxaliplatin + EGFR. Secondary objective * Evaluate the efficacy of aflibercept in combination with FOLFIRI on the 2-year overall survival rate and the objective response rate. * Evaluate the tolerance profile of aflibercept in combination with FOLFIRI. ** Observational study, national, multicenter, cohort, prospective without intervention on the therapeutic strategy.• Sponsor: Dr.Laurent Mineur Intervention: aflibercept + FOLFIRI Start Date: 2017-11-08 Last Updated: 2018-11-07 Number of Patients: 120 Recruitment Status: UNKNOWN Condition: Metastatic Colon Cancer
NCTID: NCT04450836
Title: Sequences Of REGorafenib And Trifluridine/Tipiracil in Patients With Metastatic Colorectal Cancer Study Summary: A randomized, phase II study comparing the sequences of regorafenib and trifluridine/tipiracil, after failure of standard therapies in patients with metastatic colorectal cancer Sponsor: UNICANCER Intervention: Regorafenib then Trifluridine/Tipiracil Start Date: 2020-11-23 Last Updated: 2022-12-15 Number of Patients: 340 Recruitment Status: RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT01964534
Title: Efficacy of ABI-007 Plus Gemcitabine or sLV5FU2 as First-line Therapy in Patients With Metastatic Pancreatic Cancer Study Summary: To evaluate the combination of ABI-007 with gemcitabine or with LV5FU2. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: ABI-007 Start Date: 2013-12-12 Last Updated: 2017-01-31 Number of Patients: 114 Recruitment Status: UNKNOWN Condition: Metastatic Pancreatic Cancer
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: NCT05052801
Title: Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression Study Summary: The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC) Sponsor: Amgen Intervention: Bemarituzumab Start Date: 2022-03-07 Last Updated: 2023-11-27 Number of Patients: 516 Recruitment Status: RECRUITING Condition: Gastric Cancer
NCTID: NCT03774732
Title: PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer Study Summary: Overall survival (OS) of patients with advanced (stage IIIB/IV) non-small-cell lung cancer (NSCLC) remains short after the first line of treatment with a median OS of 12.2 months in non squamous NSCLC and 9.2 months in squamous NSCLC . In this setting the programmed death 1/ligand 1 (PD-1/-L1) were targeted with nivolumab (IgG4) in advanced squamous and nonsquamous NSCLC leading to an increase of the 1-year OS rate of approximately 10-15% in both histologies. Nivolumab, pembrolizumab and atezolizumab are now considered a standard of care in 2nd line advanced NSCLC and in 1st line for pembrolizumab but but prognosis still remains poor in advanced NSCLC. Overall survival (OS) of patients with advanced (stage III/IV) NSCLC remains limited with a median OS of 12.2 months in non-squamous NSCLC and 9.2 months in squamous NSCLC if anti-PD1 alone. It is of around 16 months if pembrolizumab is combined with chemotherapy. Preclinical data indicates that anti-tumor efficacy is increased when anti-PD-1/-L1 are combined with irradiation (IR). Radiotherapy alone can elicit tumor cell death which can increase tumor antigen in the blood stream, favoring recognition by the immune system and its activation against tumor cells outside of the radiation field (=“abscopal effect”). IR may also reverse acquired resistance to PD-1 blockade immunotherapy by limiting T-cell exhaustion. Because of these preclinical and clinical data several studies analysing the combination of IR and anti-PD1 in NSCLC are ongoing. Among them, two studies are testing the administration of IR and nivolumab in stage III NSCLC: the NCT02768558 phase III trial (RTOG), and the NCT02434081 phase II trial (ETOP). Antonia et al <math display="block">2017</math> tested the use of anti-PD-L1 after chemoradiotherapy in unresectable stage III NSCLC. Median time to distant metastasis was increased (23.2 months vs. 14.6 months, p<0.001). An increase of OS is consequently expected. However, no study involving concurrent RT and pembrolizumab combined with chemotherapy in advanced NSCLC is ongoing, which is the purpose of the present study, NIRVANA-Lung. Sponsor: UNICANCER Intervention: Radiotherapy Start Date: 2019-03-21 Last Updated: 2022-07-28 Number of Patients: 460 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT00630032
Title: Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer Study Summary: RATIONALE: 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 more than one drug (combination chemotherapy) and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known whether docetaxel is more effective than ixabepilone when given after surgery and combination chemotherapy in treating breast cancer. PURPOSE: This randomized phase III trial is studying giving combination chemotherapy followed by docetaxel or ixabepilone to compare how well they work in treating patients who have undergone surgery for nonmetastatic breast cancer. Sponsor: UNICANCER Intervention: cyclophosphamide Start Date: 2007-09 Last Updated: 2023-03-15 Number of Patients: 762 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00104741
Title: Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer Study Summary: RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide together with radiation therapy may be an effective treatment for prostate cancer. It is not yet known whether giving triptorelin and flutamide together with external-beam radiation therapy is more effective than external-beam radiation therapy alone in treating prostate cancer. PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and external-beam radiation therapy to see how well they work compared to external-beam radiation therapy alone in treating patients with stage II or stage III prostate cancer. Sponsor: UNICANCER Intervention: flutamide Start Date: 2003-09-10 Last Updated: 2021-02-21 Number of Patients: 378 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT01835236
Title: Trastuzumab & Pertuzumab Followed by T-DM1 in MBC Study Summary: In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is being combined with taxanes in the first-line setting. However, since therapy with trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal treatment strategy either in combination or in sequence with chemotherapy is still under debate. This randomized phase II trial is studying a new strategy for the treatment of metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and pertuzumab, a treatment without chemotherapy. In case of disease progression, chemotherapy with T-DM1 is then performed as second-line treatment. Third-line and further line therapies are performed according to the physician’s discretion. If this new therapeutic strategy is as effective and better tolerated than the conventional strategy, this would mean a serious breakthrough in the treatment of HER2-positive metastatic breast cancer. Sponsor: Swiss Group for Clinical Cancer Research Intervention: Trastuzumab Start Date: 2013-03-03 Last Updated: 2021-03-30 Number of Patients: 208 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT02049957
Title: Safety and Efficacy Study of Sapanisertib in Combination With Exemestane or Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Metastatic Breast Cancer Study Summary: This is a phase 1b/2 study of the safety and efficacy of sapanisertib (MLN0128) in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer who progressed on treatment with everolimus in combination with exemestane or fulvestrant. Sponsor: Calithera Biosciences, Inc Intervention: Sapanisertib Start Date: 2014-02-13 Last Updated: 2023-02-08 Number of Patients: 118 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03401840
Title: STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03 Study Summary: The main objective of this national, open-label, non-randomized phase II trial is to evaluate severe late toxicity of postoperative hypofractionated stereotactic radiotherapy (SBRT) in the treatment of early stage oropharyngeal and oral cavity cancer with high risk margins. Sponsor: Centre Jean Perrin Intervention: postoperative hypofractionated stereotactic radiotherapy Start Date: 2018-01-23 Last Updated: 2023-03-07 Number of Patients: 90 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Head and Neck Neoplasms
NCTID: NCT00812240
Title: Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST) Study Summary: Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST) Sponsor: AB Science Intervention: Masitinib Start Date: 2009-01 Last Updated: 2023-02-01 Number of Patients: 335 Recruitment Status: TERMINATED Condition: Gastrointestinal Stromal Tumors
NCTID: NCT05296798
Title: A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) Study Summary: This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting. Sponsor: Hoffmann-La Roche Intervention: Phesgo Start Date: 2022-07-04 Last Updated: 2023-11-28 Number of Patients: 812 Recruitment Status: RECRUITING Condition: Locally Advanced or Metastatic Breast Cancer
NCTID: NCT03719924
Title: Nal-iri/lv5-fu Versus Paclitaxel as Second Line Therapy in Patients With Metastatic Oesophageal Squamous Cell Carcinoma Study Summary: The aim of our study is to evaluate the efficacy and safety of NALIRI plus 5FU versus paclitaxel as a second-line therapy in patients with locally advanced or metastatic ESCC who had failed to cisplatin- or oxaliplatin-based first-line chemotherapy. The hypotheses are as follows: H0: the percentage of patients alive at 9 months of 40% is not useful. H1: the percentage of patients alive at 9 months of 60% is expected. Sponsor: Federation Francophone de Cancerologie Digestive Intervention: Onivyde Start Date: 2019-03-07 Last Updated: 2023-08-18 Number of Patients: 106 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma
NCTID: NCT04660344
Title: A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy Study Summary: This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2021-05-03 Last Updated: 2023-10-10 Number of Patients: 520 Recruitment Status: RECRUITING Condition: Muscle-invasive Bladder Cancer
NCTID: NCT02820857
Title: Assessment of the Efficacy of Bevacizumab in Combination With Folfiri as Second-line Treatment in Patients Suffering From an Advanced Inoperable Poorly Differentiated Neuroendocrine Carcinoma of an Unknown or Gastroentero-pancreatic Primary Cancer Study Summary: Poorly differentiated neuroendocrine carcinomas (NEC) are a sub-group of aggressive neuroendocrine neoplasms (NEN). The most common primary sites are broncho-pulmonary and digestive. The gastroentero-pancreatic NECs (GEP-NEC) represent 7-21% of all of the NENs. Recent data on the initial presentation of GEP-NEC have been reported in two retrospective studies and a French cohort study. No standard second-line treatment has been defined for NECs. Despite a very negative prognosis, these NECs have a certain amount of chemosensitivity, close to that of bronchial NECs. Multiple-drug therapies such as Folfiri, or Folfox, or single drug treatments such as temozolomide are the proposed options but with a low level of proof Bevacizumab associated with a cytotoxic chemotherapy has shown promising results in well differentiated neuroendocrine tumors (NET), known for being hypervascular. The efficacy of bevacizumab has also been suggested in patients with NEC, but never in the context of a phase II study. Its combination with Folfiri is efficient and well tolerated in metastatic colorectal cancer. The combination Folfiri-bevacizumab potentially represents an optimized treatment compared to chemotherapy with only Folfiri. No phase II or III studies have reported results for these patients, and no on-going phase II or III trial have been identified to date. The main objective of this study is to show that, after the failure of a first-line chemotherapy using platinum-etoposide, the combination Folfiri-bevacizumab allows significant prolongation of overall survival in adult patients with GEP-NEC. Sponsor: Hospices Civils de Lyon Intervention: Folfiri-bevacizumab Start Date: 2017-09-04 Last Updated: 2023-04-19 Number of Patients: 150 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Neuroendocrine Carcinomas
NCTID: NCT00268398
Title: Combination Chemotherapy in Treating Patients With Colorectal Cancer and Resectable Metastases Study Summary: PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with colorectal cancer and resectable metastases. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: oxaliplatin, folinic acid, fluorouracil Start Date: 2002-07 Last Updated: 2012-05-22 Number of Patients: 284 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT04497844
Title: A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) Study Summary: The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS). Sponsor: Janssen Research & Development, LLC Intervention: Niraparib Start Date: 2020-09-23 Last Updated: 2023-11-09 Number of Patients: 696 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Castration-sensitive Prostate Cancer
NCTID: NCT04730544
Title: Two Combination Treatment Regimens of Nivolumab and Ipilimumab in Patients With dMMR and / or MSI mCRC. Study Summary: NIPISAFE is open-label, phase II study to identify a combination scheme of nivolumab and ipilimumab with a high level of clinical activity, but with a lower toxicity in MSI/dMMR metastatic colorectal cancer patients. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: Nivolumab 480mg + Ipilimumab Start Date: 2021-04-13 Last Updated: 2023-09-28 Number of Patients: 96 Recruitment Status: RECRUITING Condition: Colorectal Cancer Metastatic
NCTID: NCT02003924
Title: Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer Study Summary: The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer. Sponsor: Pfizer Intervention: Enzalutamide Start Date: 2013-10-31 Last Updated: 2023-10-10 Number of Patients: 1401 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Nonmetastatic Castration-Resistant Prostate Cancer
NCTID: NCT02576574
Title: Avelumab in First-line NSCLC (JAVELIN Lung 100) Study Summary: The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Avelumab Start Date: 2015-10-29 Last Updated: 2023-11-07 Number of Patients: 1214 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: First Line Non-Small Cell Lung Cancer
NCTID: NCT03959774
Title: Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment Study Summary: adherence of digital follow-up in a population of elderly patients. Sponsor: Institut Paoli-Calmettes Intervention: IPC NET Start Date: 2020-12-30 Last Updated: 2020-07-28 Number of Patients: 119 Recruitment Status: NOT_YET_RECRUITING Condition: Breast Cancer
NCTID: NCT04988295
Title: A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure Study Summary: The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. Sponsor: Janssen Research & Development, LLC Intervention: Lazertinib Start Date: 2021-11-17 Last Updated: 2023-11-08 Number of Patients: 776 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT02861742
Title: Impact of Emotional Skills of Young Women and Their Partner on Adjustment to Cancer Study Summary: The KALICOU 3 study will evaluate the effect of emotional skills of patients and their partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance. Sponsor: Centre Oscar Lambret Intervention: Delivery of questionnaires Start Date: 2016-07-25 Last Updated: 2019-06-26 Number of Patients: 800 Recruitment Status: UNKNOWN Condition: Aging
NCTID: NCT05041842
Title: Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer Study Summary: The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment. Despite these advances, the development of brain metastases remains a serious and devastating complication that decreases quality of life and increases morbidity and mortality. The HER2CLIMB randomized study demonstrated that adding the investigational drug tucatinib to the standard treatment trastuzumab and capecitabine improved both progression-free survival and overall survival in people diagnosed with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer, previously treated with trastuzumab, pertuzumab, and T-DM1. In patients with brain metastases, the 1-year progression-free survival was 25% in the tucatinib group and 0% in the placebo group. These results suggest that tucatinib may be a new standard treatment for HER2-positive metastatic disease. The aim of the non-randomized phase II study, InTTercePT, is to evaluate the effectiveness of adding tucatinib to trastuzumab and pertuzumab in the event of cerebral progression, after the end of local treatment. Sponsor: UNICANCER Intervention: Tucatinib Start Date: 2021-12-17 Last Updated: 2023-09-22 Number of Patients: 55 Recruitment Status: RECRUITING Condition: Metastatic Breast Cancer With a Isolated Brain Progression
NCTID: NCT03350776
Title: Practices and Organizations Related to Emerging Occupations of Care (EPOCK) Coordination in Oncology Study Summary: Several stakeholders are implied in cancer care pathways and there is a need for coordinating their actions. New occupations of care coordination have thus emerged. However, the conditions of their efficiency have been too few reported and included discrepancies between reports. In this context, the main objective is to propose a modeling of care coordination and associated emerging occupations (nurse-based) by comparing theoretical expected outcomes to professionals, patients and caregivers representations. Sponsor: University Hospital, Bordeaux Intervention: Care coordination Start Date: 2018-04-17 Last Updated: 2020-06-19 Number of Patients: 960 Recruitment Status: COMPLETED Condition: Care Coordination in Oncology
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
NCTID: NCT00068744
Title: Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as mitomycin, fluorouracil, and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy and mitomycin are more effective when combined with fluorouracil or with cisplatin in treating anal cancer . PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy and mitomycin together with fluorouracil works compared to radiation therapy, mitomycin, and cisplatin in treating patients with locally advanced anal cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cisplatin Start Date: 2003-07 Last Updated: 2012-09-24 Number of Patients: 88 Recruitment Status: TERMINATED Condition: Anal Cancer
NCTID: NCT03515798
Title: Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer Study Summary: This phase II multicentre randomized open-label study will assess the safety and efficacy of Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer. Pembrolizumab will be administered every 3 weeks during the neoadjuvant chemotherapy. Tissue and blood samples will be collected pre- and post-treatment for translational research. Sponsor: Institut Paoli-Calmettes Intervention: Pembrolizumab Injection Start Date: 2018-07-24 Last Updated: 2020-07-02 Number of Patients: 81 Recruitment Status: RECRUITING Condition: Inflammatory Breast Cancer
NCTID: NCT00053911
Title: Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic 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, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is more effective than observation in treating relapsed nonmetastatic breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of observation in treating women who have undergone surgery for relapsed nonmetastatic breast cancer. Sponsor: UNICANCER Intervention: anastrozole Start Date: 2002-11 Last Updated: 2014-12-16 Number of Patients: NA Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT00664911
Title: Combination Chemotherapy in Treating Older Patients With Solid Tumour, Study Summary: RATIONALE: 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 more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating older patients with solid tumour. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: chemotherapy Start Date: 2008-03 Last Updated: 2013-10-16 Number of Patients: 516 Recruitment Status: COMPLETED Condition: Solid Tumor Regardless of Localization and Stage
NCTID: NCT00006111
Title: Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract 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 surgery with chemotherapy and radiation therapy may be an effective way to treat cancer of the urinary tract. PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy and radiation therapy in treating patients who have stage II, stage III, or stage IV cancer of the urinary tract . Sponsor: UNICANCER Intervention: cisplatin Start Date: 1999-04 Last Updated: 2021-02-21 Number of Patients: 53 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT04916613
Title: ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable) Study Summary: This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors. Sponsor: UNICANCER Intervention: Darolutamide 300 mg Start Date: 2022-04-19 Last Updated: 2023-05-11 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Prostate Cancer Metastatic
NCTID: NCT06119581
Title: A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C Study Summary: The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing. Sponsor: Eli Lilly and Company Intervention: LY3537982 Start Date: 2024-01-03 Last Updated: 2023-11-07 Number of Patients: 1016 Recruitment Status: NOT_YET_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT02361099
Title: SENTINEL : Impact of the Use of a Web-application for the Detection of Lung Cancer Relapse Study Summary: This is a study that evaluates an optimization of the monitoring of patients with lung cancer in order to extend the survival of patients by improving their quality of life and decreasing anxiety generated by the achievement of balance sheets imaging. The spacing of the follow-up imaging also helps to reduce the cost of such monitoring. The main objective of this study is to evaluate the overall survival of patients. Sponsor: Weprom Intervention: Monitoring by SENTINEL application Start Date: 2014-06-03 Last Updated: 2020-06-29 Number of Patients: 133 Recruitment Status: COMPLETED Condition: Lung Cancer
NCTID: NCT02404935
Title: Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC) Study Summary: National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy. Sponsor: UNICANCER Intervention: Cetuximab Start Date: 2013-11-22 Last Updated: 2022-03-24 Number of Patients: 139 Recruitment Status: COMPLETED Condition: Metastatic Colorectal Cancer
NCTID: NCT05909111
Title: MR-Only Based Adaptive External Beam Radiation Therapy of Cervical Cancer on Ethos Therapy: Feasibility Study Study Summary: Current management of patients treated with External Beam Radiation Therapy (EBRT) for cervical cancer with a classical Image-guided Radiation Therapy (IGRT) strategy involves a complex, not entirely satisfactory, treatment workflow. Indeed, in our institution, two workflows have been designed to take into account the inter-fraction motion of cervix and uterus : an Internal Target Volume (ITV)-based approach and a plan of the day strategy requiring both several planning-CT (Computed Tomography) acquisitions with variable bladder filling.The upcoming installation of a Varian Ethos therapy system in our institution will allow us to implement a less cumbersome online adaptive radiotherapy strategy (oART), which, by conforming to the daily anatomy, will enable a reduction in the Clinical Target Volume (CTV) to Planning Target Volume (PTV) margins leading to an expected reduction in dose delivered to organs at risk (OAR) .On the other hand, MR (Magnetic Resonance)-only treatment planning is playing an increasing role in radiotherapy, notably in the treatment of prostate cancer. MR-only workflows are known (a) to provide the most reliable delineation in soft tissues and (b) to decrease spatial uncertainties by suppressing the Magnetic Resonance Imaging (MRI)-CT co-registration. Regarding the management of cervical cancer, the importance of MRI is well established and its use becomes essential. Combining a MR-only workflow with an adaptative one on the Varian Ethos system, could lead to an improved management of patients treated for cervical cancer with an expected reduction in margins and volumes treated (thanks to MRI delineation and online adaptation) and therefore a reduction of OAR toxicity. Including regular multi-parametric MR imaging during and after the course of the treatment could also provide in the future an assessment of the treatment response. One of the important challenges in developing this specific workflow is to have a reliable synthetic CT (derived from MRI) to (a) provide electron or mass density for treatment planning calculations and (b) allow accurate online repositioning/deformation with Ethos Cone Beam Computed Tomography (CBCT). The other fundamental challenge is to provide a formal assessment of the clinical benefit of introducing MR-only simulation and planning in an oART workflow. This project aims to demonstrate the feasibility of setting up an adaptive workflow on the ETHOS platform with the sole use of MR patient image.The project is divided into two parts. The first part consists in demonstrate the feasibility of the workflow on 15 patients with cervix cancer. Sponsor: Recherche clinique Intervention: Magnetic resonance imaging Start Date: 2022-12-01 Last Updated: 2023-06-18 Number of Patients: 15 Recruitment Status: RECRUITING Condition: Cervical Cancer
NCTID: NCT00976911
Title: AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer Study Summary: This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals. Sponsor: Hoffmann-La Roche Intervention: Bevacizumab Start Date: 2009-10-29 Last Updated: 2022-06-21 Number of Patients: 361 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT03955913
Title: A Study to Identify Participants With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations Study Summary: The purpose of this non-interventional study is to identify participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations through molecular testing of their archival tumor tissue. Sponsor: Janssen Research & Development, LLC Intervention: Archival Tumor Tissue Sample Start Date: 2019-08-01 Last Updated: 2023-02-24 Number of Patients: 3679 Recruitment Status: COMPLETED Condition: Urothelial Cancer
NCTID: NCT00673335
Title: Letrozole in Preventing Breast Cancer in Postmenopausal Women With a BRCA1 or BRCA2 Mutation Study Summary: RATIONALE: Letrozole may prevent breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in preventing breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation. Sponsor: UNICANCER Intervention: letrozole Start Date: 2008-05 Last Updated: 2023-05-11 Number of Patients: 170 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: brca1 Mutation Carrier
NCTID: NCT04191135
Title: Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009) Study Summary: The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are: # Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to progression-free survival (PFS). # Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to overall survival (OS). As of Amendment 3, study enrollment is being discontinued. Participants who are receiving benefit from the study intervention may continue treatment until criteria for discontinuation are met. Participants who are on study treatment or in follow-up phase will no longer have tumor response assessments by BICR. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-12-19 Last Updated: 2023-06-23 Number of Patients: 462 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Triple Negative Breast Neoplasms
NCTID: NCT03079011
Title: PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection Study Summary: This study is a randomized, open-label, multicentric, phase III trial conducted in patients receiving aromatase inhibitor and palbociclib as first line therapy for estrogen receptor (ER)-positive HER2-negative metastatic breast cancer and which aims to evaluate, at the onset of ESR1 mutations in circulating tumor DNA, the efficacy of a change of the hormone therapy (aromatase inhibitor (AI) changed to fulvestrant) combined to palbociclib, together with the safety of hormone therapy and palbociclib combination in the overall population. Sponsor: UNICANCER Intervention: Palbociclib 125mg Start Date: 2017-03-22 Last Updated: 2023-09-22 Number of Patients: 1017 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT02024035
Title: Protocole Advanced RadioTherapy ORL Study Summary: The purpose of this study is to do health economic evaluation of tomotherapy and dynamic arctherapy (2 techniques exist: RapidArc and Vmat). This study evaluate also local disease control after 18 months in patients with an ENT epidermoid carcinoma and treated by tomotherapy orarctherapy . The number of patients required in this study is: 300: * Number of patients treated with tomotherapy: 120 * Number of patients treated with dynamic arctherapy RapidArc: 120 * Number of patients treated with dynamic arctherapy Vmat: 60 This is a prospective; multicentric and non randomized study. Sponsor: Centre Leon Berard Intervention: Radiotherapy Start Date: 2009-11 Last Updated: 2013-12-31 Number of Patients: 180 Recruitment Status: COMPLETED Condition: Head and Neck Squamous Cell Carcinoma
