Thonon Les Bains

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 evaluating treatments for patients with hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer that has a PIK3CA mutation. This Phase 3 study compares the effectiveness and safety of RLY-2608 combined with fulvestrant versus capivasertib combined with fulvestrant. The study focuses on patients whose cancer returned or worsened after treatment with a CDK4/6 inhibitor. Participants will receive either RLY-2608 taken orally twice daily every day in 28-day cycles or capivasertib taken orally twice daily on days 1 through 4 each week within a 28-day cycle. All participants will also receive fulvestrant by intramuscular injection on day 1 and day 15 of the first cycle, then on day 1 of each following 28-day cycle. Treatment continues until disease progression or other criteria are met. During the study, researchers will monitor participants regularly to assess progression-free survival, which is the time from starting treatment until cancer progression or death. Assessments include radiographic imaging based on RECIST v1.1 criteria and safety evaluations. The study duration may extend up to approximately 77 months, allowing for long-term monitoring of treatment effects and safety.

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.

Colorectal cancer mainly affects elderly patients, with over half of new cases in France occurring in those aged 70 or older. Adjuvant chemotherapy has shown benefits in disease-free and overall survival after stage III colon cancer surgery, but its use in elderly patients remains limited. This phase III randomized study explores whether adjuvant chemotherapy improves disease-free survival in elderly patients and which chemotherapy regimen is most effective, addressing concerns about benefits for both unfit and fit elderly patients. Participants will be divided into two groups based on a multidisciplinary evaluation including a geriatrician. One group will receive fluoropyrimidine-based chemotherapy (LV5FU2 or capecitabine), and the other will receive oxaliplatin-based chemotherapy (FOLFOX4 or XELOX). Some patients may be assigned to observation only. Treatments will begin within 12 weeks after surgery. The study also evaluates specific biological markers common in elderly tumors, such as mismatch repair deficiency. During the study, participants will undergo assessments including geriatric questionnaires and medical monitoring. Researchers will track disease-free survival over three years following the last patient's enrollment. Safety and treatment effects will be monitored, with exclusion of patients expected to live less than four years or those unable to comply with follow-up. The study aims to better understand chemotherapy benefits in an elderly population after colon cancer surgery.

There is a wide variation in how rapid sequence induction is performed in operating rooms worldwide. This study aims to describe how French anesthesiologists prevent serious blood flow problems during rapid sequence anesthetic induction in adult patients. It focuses on the occurrence of major hemodynamic disorders, such as low or high blood pressure, sustained arrhythmias, or cardiac arrest within the first 10 minutes after anesthesia begins. Participants will undergo rapid sequence anesthetic induction, a process used to quickly induce general anesthesia for patients at high risk of lung fluid aspiration. The study will observe the clinical practices of pre-oxygenation, induction, and intubation, and check how well these practices follow the formal expert recommendations from 2017 and 2018. Data on the prevention of gastric fluid inhalation, equipment used, drugs administered, and clinical parameters will be collected during the induction process. Throughout the study, researchers will monitor neurological and cardio-respiratory signs and record any complications within the first 10 minutes after anesthesia induction. The main outcome measured is the occurrence of major hemodynamic disorders during this period. The study is observational and multicenter, involving adult patients undergoing rapid sequence induction in France.

This research aims to observe patients in France who have HER2-negative early breast cancer and are treated with olaparib. The study focuses on understanding how many patients complete the full planned course of olaparib treatment, which is given as adjuvant therapy following initial cancer treatment. It is a national, multicenter, prospective cohort study conducted without altering the usual care provided by doctors. Patients enrolled will be those starting adjuvant olaparib treatment based on their doctor's decision. There are no experimental interventions or treatment changes imposed by the study. The study captures real-world use of olaparib across multiple centers in France. Participants will be followed for at least 18 months after joining the study to see if they complete the full duration of olaparib treatment. Researchers will collect data on treatment adherence and other relevant clinical information during this period. The main outcome measured is the proportion of patients who receive olaparib for the entire planned treatment period.

Researchers are evaluating the effects of acetylsalicylic acid and atorvastatin on overall survival in male patients with castrate-resistant prostate cancer (CRPC) who are starting their first-line treatment for CRPC. This international, multicenter, open-label phase III clinical trial uses a 2x2 factorial randomized design to study whether these drugs improve survival outcomes in this patient population. Participants receive acetylsalicylic acid at a dose of 100 mg and atorvastatin at 80 mg as part of the trial interventions. The trial compares these treatments in different combinations to assess their impact on overall survival. The study does not specify additional treatment schedules or extension phases but focuses on the effects of these drugs during the initial treatment period for CRPC. During the study, participants are monitored for overall survival, calculated from the date of randomization until death, with follow-up extending up to 15 years. Eligibility assessments include confirming CRPC status with specific testosterone and PSA criteria, imaging for metastases, performance status evaluation, and kidney and liver function tests. Safety is monitored by excluding patients with certain liver conditions, drug contraindications, or serious medical issues, and patient adherence is supported through informed consent and clinical follow-up procedures.

Researchers are evaluating a chemotherapy regimen for women with poor prognostic ovarian cancers who have unfavorable tumor chemosensitivity and incomplete debulking surgery. This pragmatic, open-label, multicenter, randomized phase III trial compares a salvage weekly dose-dense chemotherapy schedule with the continuation of the standard chemotherapy regimen. The study stratifies participants based on factors like planned bevacizumab use, BRCA mutation status, and KELIMTM score categories to assess effectiveness and overall survival. Participants will be randomly assigned to one of two groups: the experimental arm receives a dose-dense regimen of carboplatin and paclitaxel, with carboplatin given every three weeks and paclitaxel administered weekly for three cycles; the standard arm continues the same three-weekly carboplatin-paclitaxel regimen used during neo-adjuvant chemotherapy. The trial focuses on confirming the superiority of the adjusted chemotherapy approach in routine clinical practice. During the study, researchers will monitor the percentage of patients undergoing late complete debulking surgery within 100 days and track overall survival for up to five years. Participants will undergo regular assessments, including clinical evaluations and laboratory tests, to ensure safety and compliance. The study duration covers treatment cycles and extended follow-up to evaluate long-term outcomes.