Coudekerque Branche

Researchers are studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.

Researchers are evaluating the effect of digital monitoring of self-reported symptoms on how treatment is managed in patients with advanced clear cell renal cell carcinoma RCC receiving cabozantinib plus nivolumab. This Phase 4 study focuses on the first three months of combined treatment in a real-life setting, aiming to improve patient care by adjusting treatments based on weekly symptom reports. The study is sponsored by Centre Francois Baclesse. Participants receive cabozantinib orally once daily and nivolumab intravenously every two weeks as prescribed in the labeling. During this treatment, a digital monitoring system collects weekly patient reports on treatment tolerance. The system uses an algorithm to classify patients risk levels and generate alerts that may lead to treatment adjustments. This digital telemonitoring platform supports early detection of adverse events related to the combination therapy. Participants will be involved in regular weekly self-reporting of symptoms through a mobile digital device for up to six months. Researchers will assess treatment management adjustments within the first three months and track symptom evolution, fatigue, quality of life, anxiety, depression, pain, and adverse reactions over six months. The study evaluates the feasibility of this digital approach to follow-up and the impact of alerts generated by the monitoring platform on patient management and outcomes.

Researchers are evaluating the effects of American ginseng combined with vitamin C from Camu Camu berries on fatigue in patients treated for localized breast or gynecological cancer. This multicenter randomized trial aims to assess the safety and efficacy of the dietary supplement Qiseng in improving cancer-related fatigue. The study is randomized, double-blind, and placebo-controlled, led by the Centre Francois Baclesse. Participants receive either Qiseng, containing 200 mg of P. quinquefolius extract 30 mg ginsenosides plus 30 mg vitamin C, or a placebo made of microgranules without active extracts. Both groups take 2 capsules daily for 8 weeks. The trial includes detailed monitoring of fatigue and other quality-of-life aspects during and after treatment. During the study, participants will have their fatigue levels assessed after 1 week and 4 weeks following the 8-week treatment. Researchers will also evaluate other fatigue dimensions, treatment-related side effects, quality of life, anxiety, cognitive function, physical activity, sleep quality, and treatment acceptability at multiple timepoints. The study spans approximately 12 weeks with close follow-up for safety and outcome measurement.

Squamous cell carcinoma of the anus is a rare but increasingly common cancer, often linked to human papillomavirus HPV. For early-stage tumors, combined radiotherapy and chemotherapy with 5FU and mitomycin-C provide good outcomes, but advanced tumors have a poor prognosis with a high relapse rate. Researchers are studying a new approach combining induction chemotherapy with docetaxel, cisplatin, and 5FU mDCF followed by standard chemoradiotherapy to improve treatment results for locally advanced anal cancer T3-4 or N1. This is a randomized phase 3 trial comparing this new strategy to the current standard treatment. The study includes two groups one receives the usual chemoradiotherapy, which involves 33 radiotherapy sessions over 6.5 weeks combined with mitomycin-C and capecitabine chemotherapy taken on radiotherapy days. The other group starts with 4 cycles of mDCF chemotherapy given every two weeks before receiving the same chemoradiotherapy as the control group. Radiotherapy uses intensity-modulated external irradiation with a targeted boost to the tumor and involved lymph nodes. Participants will be followed after treatment with check-ups at 8 weeks, then every 4 months for two years, and every 6 months in the third year. Follow-up includes clinical exams and imaging scans CT and MRI. The main measure of success is disease-related event-free survival two years after treatment. Other outcomes include overall survival, colostomy-free survival, treatment side effects, tumor response, and quality of life. The total study duration for each participant may extend over several years including this follow-up period.

Researchers are studying patients with metastatic colorectal cancer to identify clinical and biological factors that predict how well fruquintinib works in real-world settings. The study aims to confirm survival and safety results seen in previous trials and to better understand treatment outcomes, especially in older patients aged 70 and above, who have been underrepresented in earlier research. This cohort is designed to optimize treatment pathways by pinpointing patients who may benefit most from fruquintinib. Participants will receive fruquintinib, an oral drug that targets specific blood vessel growth receptors, given as 5 mg daily for 21 days followed by a 7-day break. This cycle repeats until the cancer progresses, unacceptable side effects occur, the patient dies, or the patient chooses to stop treatment. The study includes patients treated under compassionate use or after marketing authorization in France, integrating routine clinical practice data. During the study, participants will be monitored for overall survival up to one year after starting treatment, which is the main outcome measured. Additional monitoring includes progression-free survival within the same timeframe. The study involves collecting biological samples like circulating tumor DNA and tumor tissue blocks. Safety, survival, and treatment response data will be gathered to support understanding of fruquintinibs effects in everyday clinical use. The study is expected to continue until the end of 2031.

Researchers are studying advanced cancer of the stomach and the gastro-esophageal junction, a serious disease with low survival rates. The trial focuses on patients whose cancer has progressed after two or three prior treatments. The study aims to evaluate whether combining the oral drug trifluridinetipiracil with the anti-angiogenic drug fruquintinib can improve survival compared to trifluridinetipiracil alone. This international Phase III trial builds on recent advances in immunotherapy and targeted therapies for this cancer type. Participants are randomly assigned to one of two groups. One group receives trifluridinetipiracil alone in 28-day cycles, taking the drug by mouth twice daily on Days 1 to 5 and Days 8 to 12 with rest days in between, repeated every 4 weeks. The other group receives the same trifluridinetipiracil schedule plus fruquintinib by mouth once daily for 21 days each cycle. Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant chooses to stop. During the study, participants undergo regular assessments to monitor overall survival up to 18 months after starting treatment. Researchers will also measure progression-free survival during this period. Patients will have tumor evaluations, laboratory tests, and monitoring for treatment side effects. Participants must meet specific health criteria and agree to biological studies. The study provides close follow-up to evaluate the effects of the treatments over time.