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Researchers are monitoring the use of the Virtue4 Male Sling System in men with stress urinary incontinence following prostate surgery. This study aims to collect real-world medical data on the device's effectiveness and safety over a period of 12 and 36 months after implantation. The study is a multicenter, prospective, non-interventional follow-up involving urologists experienced with the device. The Virtue4 Male Sling is an implantable device made of polypropylene mesh designed to support the urethra and treat male stress urinary incontinence caused by intrinsic sphincter deficiency. Participants receive the device through surgical implantation, and their progress is tracked during routine clinical visits. Follow-up visits occur around baseline (preoperative and implantation), between 1 and 3 months post-operation, and at 12 months. Afterward, annual questionnaires are mailed for two more years to continue monitoring. Participants are involved in routine clinical care with additional questionnaires to assess their condition. Researchers evaluate patient-reported improvement and monitor any adverse events at 12 months. The total study duration includes follow-up up to three years post-implantation, allowing long-term observation of device performance and safety in a real-world setting.

Researchers are conducting a Phase III, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of androgen deprivation therapy (ADT) with or without darolutamide in men with newly diagnosed metastatic prostate cancer who have vulnerable functional ability. These patients have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 participants who meet specific frailty and disease criteria. Participants will be randomly assigned to one of two groups: the experimental group will receive ADT plus darolutamide 600 mg taken orally twice daily, and the control group will receive ADT plus a placebo taken orally twice daily. Treatment will continue until there is evidence of disease progression on radiographic scans or if the patient or investigator decides to stop treatment for reasons such as side effects or other health conditions. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, additional cancer treatments, and any ongoing or new side effects. During the study, patients will undergo assessments according to established prostate cancer clinical trial criteria to evaluate their response to treatment. Researchers will monitor the time until disease progression or death for up to 18 months as the main outcome. Safety and treatment effects will be tracked through scheduled visits, laboratory tests, and imaging. The long-term follow-up will help understand survival outcomes and the impact of subsequent treatments over many years.

Researchers are evaluating the benefits of a specialized spa therapy for patients experiencing severe late skin and soft tissue reactions, called fibrosis, which occur at least six months after radiotherapy for breast cancer or upper aerodigestive tract cancer. This research focuses on improving quality of life related to the skin symptoms caused by this fibrosis, a condition that has received limited attention despite its impact. The study is designed as a controlled, randomized, multicenter trial with simple blinding for investigators. The treatment being studied is a dermatologically oriented thermal cure that combines baths with muscle-relaxing and sedative effects, sprays that reduce swelling, and high-pressure thermal water jets applied for several minutes. Participants also attend educational workshops covering relaxation, sophrology, and hygiene. The study compares immediate treatment with delayed treatment after six months to assess the therapy's effects. Participants will undergo self-assessment of their dermatological quality of life six months after treatment using a specific questionnaire (DLQI). Researchers will monitor skin and soft tissue symptoms, collect patient-reported outcomes, and evaluate safety. The total study duration includes treatment and follow-up to capture changes in quality of life and the skin condition over time.

Researchers are evaluating the effectiveness of niraparib alone versus niraparib combined with bevacizumab as maintenance treatments in women newly diagnosed with advanced stage IIIA/B/C high-grade epithelial ovarian cancer. This phase II, randomized, open-label, multicenter study focuses on patients who have no visible disease remaining after frontline surgery and have completed platinum-based chemotherapy with or without bevacizumab. The study stratifies participants based on BRCA mutation status, cancer stage, and prior hyperthermic intraperitoneal chemotherapy. Participants receive initial chemotherapy with carboplatin and paclitaxel given intravenously every three weeks for five cycles. Bevacizumab (or its biosimilar MVASI) is introduced intravenously starting from the second chemotherapy cycle for five cycles and continued during maintenance therapy for a total of 15 months. After chemotherapy, niraparib is administered orally once daily as maintenance treatment, either alone or in combination with bevacizumab, for up to two years. Throughout the study, participants undergo regular monitoring including imaging scans and laboratory tests to assess disease progression and treatment safety. The main outcome measured is progression-free survival up to 24 months after randomization, defined as the time until tumor progression or death. Researchers also track treatment adherence, side effects, and overall health status during the follow-up period, which lasts up to two years after starting maintenance therapy.

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.

Researchers are evaluating the effectiveness of the GERONTE integrated care pathway, which uses information and communication technology (ICT) to improve the quality of life of older patients with multiple health conditions and cancer in France. This study involves hospitals organized in clusters and follows a stepped wedge randomized controlled trial design, where different sites begin the intervention at different times in two-month steps. The main goal is to measure quality of life using the EORTC QLQ-C30 questionnaire six months after the intervention starts. The intervention, called GERONTE, aims to bring together all health professionals involved in caring for patients with multiple illnesses into a coordinated care pathway. Each hospital site will enroll about 10 patients every two months, ensuring the sample reflects the types of cancer treated at that center. The order of intervention rollout is randomized, and patient inclusion is carefully managed to maintain consistency. Data on app usage, hospitalizations, anxiety, autonomy, and mortality will be collected at 3, 6, 9, and 12 months. Participants will be regularly monitored through questionnaires and clinical data collection over the course of the study. Researchers will gather information on healthcare resource use and intervention costs continuously during follow-up. Qualitative analyses will also be conducted at the time of intervention implementation and throughout the study. The total follow-up period spans at least 12 months after patient inclusion, focusing on patient-centered outcomes and the practical use of the GERONTE system in routine care.

Researchers are investigating treatment options for men with castration-resistant prostate cancer (CRPC) that has spread to a limited number of sites, called oligometastatic CRPC. This form of prostate cancer continues to grow despite hormone therapy to lower male sexual hormones. The trial aims to evaluate whether adding stereotactic body radiotherapy (SBRT), a precise radiation treatment, to darolutamide, a new generation hormone therapy, improves outcomes compared to darolutamide alone. This phase III trial focuses on patients with metastases detected by advanced functional imaging techniques such as PET scans. Participants will be randomly assigned to receive either darolutamide with SBRT or darolutamide alone. Darolutamide is given orally at a dose of 1200 mg per day (two 300 mg tablets twice daily) for up to five years from randomization. SBRT is delivered over one week in three sessions of 10 Gy each, totaling 30 Gy. All patients continue androgen deprivation therapy (ADT) during the study. The study includes a pre-inclusion period for eligibility assessment followed by treatment and monitoring for up to 60 months after randomization. During the study, patients will visit the hospital regularly for medical exams to evaluate their health and treatment tolerance. Researchers will track disease progression and survival using radiographic imaging and other evaluations. The main outcome measured is radiographic progression-free survival from randomization until disease progression or death, for up to five years. The study also includes clinical and biological assessments, tumor evaluations, and safety monitoring throughout the trial 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.