Coudekerque Branche

Researchers are exploring a treatment approach for women with early-stage hormone receptor-positive, HER2-negative breast cancer who face an intermediate risk of cancer recurrence. This phase III trial builds on previous findings that adding the drug ribociclib, a CDK4/6 inhibitor, to standard hormone therapy after surgery can extend the time patients remain free from invasive disease. The study aims to see if using ribociclib allows some patients to avoid chemotherapy and its side effects without compromising treatment effectiveness. Participants will either receive chemotherapy followed by hormone therapy combined with ribociclib or a de-escalated treatment plan that reduces or omits chemotherapy while still using ribociclib and hormone therapy. Ribociclib will be administered for three years as part of the adjuvant treatment after surgery. The study is designed to reflect routine clinical practices for deciding chemotherapy eligibility, using standard pathological assessments and genomic tests. Throughout the trial, women will undergo regular monitoring, including clinical visits, laboratory tests, and heart function assessments, to ensure safety and treatment adherence. Researchers will measure invasive breast cancer-free survival over a period of up to 12 years from randomization. The study also tracks patients' ability to comply with treatment schedules and evaluates long-term outcomes to confirm if chemotherapy can be safely reduced or avoided in this group.

Researchers are conducting a multicenter prospective study to identify microbiome-based biomarkers in patients with cancer. This study focuses on collecting biological samples to understand the relationship between the microbiome and cancer treatment outcomes. Participants will provide stool and blood samples multiple times during the study. Samples are collected at baseline or before the third treatment injection, at the first evaluation with CT-scan, at six months or more after the first injection, during any toxicity events, at relapse, and one week after completing antibiotics treatment. Throughout the study, participants will undergo these sample collections at specified time points to monitor changes in their microbiome. The main outcome being measured is overall survival up to two years. Patients will provide informed consent and cooperate with study procedures while being followed for the duration of their cancer treatment and monitoring.

Researchers are evaluating the effects of Qiseng®, a dietary supplement made from American ginseng extract combined with vitamin C from Camu Camu berries, on fatigue in female patients treated for localized breast or gynecological cancer. This multicenter randomized, placebo-controlled, double-blind trial aims to assess the safety and effectiveness of Qiseng® in reducing cancer-related fatigue experienced after treatment. Participants will be randomly assigned to receive either Qiseng® or a placebo, each given as two capsules daily for 8 weeks. The study involves a comparison between these two groups to monitor changes in fatigue levels over the treatment period. During the trial, researchers will assess participants' fatigue scores using a visual scale at one week and four weeks after finishing the 8-week treatment. Participants will be monitored for safety and adherence throughout the study, which includes follow-up assessments to measure the change in fatigue associated with the intervention.

Researchers are evaluating treatments for frail patients with advanced, recurrent, or metastatic adenocarcinoma of the stomach, esophagus, or gastroesophageal junction that do not overexpress HER2. This randomized Phase II trial compares two chemotherapy combinations: Trifluridine/Tipiracil plus Oxaliplatin with or without Nivolumab, versus the FOLFOX regimen with or without Nivolumab. The study aims to assess progression-free survival over up to five years from randomization. The treatments include Trifluridine/Tipiracil given in 14-day cycles with doses twice daily for 5 days followed by 9 days of rest, and Oxaliplatin administered intravenously every two weeks with a gradual dose increase during the first eight cycles. In the FOLFOX group, patients receive Folinic Acid, Oxaliplatin, and 5-fluorouracil in a two-week cycle. Nivolumab infusions occur every two weeks for up to two years or until disease progression or intolerable toxicity. After eight cycles or if neuropathy occurs, Oxaliplatin is stopped, and the other drugs continue alone until progression or intolerance. Participants will be monitored through evaluations of tumor lesions, organ function, and adverse effects. Outcome measures focus on time without disease progression or death. Safety monitoring includes regular blood tests and assessments of side effects. Participants provide consent and must be available for treatment and follow-up during the study duration, which may extend up to five years. Archived tumor samples will be collected for additional research purposes.

Researchers are investigating treatments for locally advanced anal squamous cell carcinoma, a rare but increasing cancer often linked to human papillomavirus (HPV). The study compares standard chemoradiotherapy, which combines radiation and chemotherapy with 5FU and mitomycin-C, to a new approach adding induction chemotherapy (modified DCF protocol) before the standard chemoradiotherapy. This randomized phase 3 trial aims to improve disease-related event-free survival and other outcomes such as overall survival, colostomy-free survival, treatment tolerability, response rate, and quality of life in patients with T3-T4 or N1 stage anal cancer without metastasis. Participants in the experimental group receive four cycles of induction chemotherapy (docetaxel, cisplatin, and 5-FU given every two weeks), followed by standard chemoradiotherapy consisting of 33 sessions of radiation over 6.5 weeks combined with mitomycin during weeks 1 and 5 and capecitabine taken on radiation days. The control group receives only the standard chemoradiotherapy. Radiation is delivered using intensity-modulated external irradiation (IMRT-SIB) targeting the pelvis and tumor area with specified doses. During the study, patients undergo follow-up visits starting 8 weeks after treatment, then every 4 months for two years, and every 6 months for a final year. Follow-up includes clinical exams and imaging tests such as CT and MRI. The study measures disease-related event-free survival at 2 years after treatment completion as the primary outcome. Participants must be adults aged 18 or older with measurable tumors on MRI and able to receive chemotherapy and radiotherapy, with additional health criteria assessed before enrollment.

Researchers are investigating treatments for advanced metastatic adenocarcinoma of the stomach and gastro-esophageal junction, a serious cancer with low survival rates. Current treatments include chemotherapy combinations and immunotherapy, which have improved outcomes for some patients. However, when cancer progresses after these therapies, options are limited, and new approaches are needed to extend survival and maintain quality of life. This international Phase III trial (FRUQUITAS) tests whether adding fruquintinib, an anti-angiogenic drug, to the oral chemotherapy drug trifluridine/tipiracil can improve survival for patients whose cancer has continued to grow despite prior treatments. The study compares two groups: one receiving trifluridine/tipiracil alone and the other receiving trifluridine/tipiracil combined with fruquintinib. Trifluridine/tipiracil is given orally twice daily on days 1 to 5 and days 8 to 12 of a 28-day cycle, repeated until disease progression or unacceptable side effects. Fruquintinib is taken orally once daily for 21 days of a 28-day cycle, also continued until progression or toxicity. This combination aims to block the tumor's blood supply while providing chemotherapy. The trial evaluates if this approach extends overall survival compared to chemotherapy alone. Participants will be adults with metastatic adenocarcinoma who have received two or three previous treatment lines. They will undergo regular assessments including tumor evaluations per RECIST criteria, blood tests to monitor organ function, and safety checks. Researchers will measure overall survival up to 18 months after starting treatment. The study involves ongoing monitoring for side effects and treatment tolerance, with participation lasting until disease progression, unacceptable toxicity, or withdrawal. Biological samples may also be collected for further research, and informed consent is required before enrollment.