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Found 9 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying metastatic renal cell carcinoma (RCC), a type of kidney cancer that spreads to other parts of the body, affecting many patients annually in France. This study focuses on patients with oligoprogressive disease, where only a few metastatic sites (1 to 3) show progression while the rest remain controlled under ongoing systemic treatments like targeted therapies or immunotherapy. The goal is to evaluate stereotactic radiotherapy (SRT) as a focused treatment to control these progressing sites and potentially delay the need for changing systemic therapies. The study involves delivering stereotactic radiotherapy, which uses high doses of radiation in one or a few sessions to target metastatic sites specifically. Patients with up to three progressive metastases eligible for SRT will receive this treatment concurrently or sequentially alongside their current systemic therapy. This approach aims to control tumor growth locally and possibly stimulate a broader immune response. The trial is a Phase II study, assessing this treatment strategy in patients receiving first or second-line systemic therapies. Participants will undergo imaging scans to confirm disease progression and lesion sizes, with follow-up assessments to monitor progression-free survival six months after randomization. Researchers will evaluate how well the targeted radiotherapy controls tumor sites and delays further disease progression. Patients will be closely monitored for treatment effects, ability to continue systemic therapy, and overall safety throughout the study period.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of lorlatinib in patients with untreated ALK-positive non-small-cell lung carcinoma (NSCLC) in a real-world French context. The study focuses on adults aged 18 years or older who have locally advanced or metastatic ALK-positive NSCLC confirmed by specific diagnostic methods. This non-interventional study aims to understand how lorlatinib performs outside of controlled clinical trial settings. Participants will receive lorlatinib as the treatment for ALK-positive NSCLC. Before starting treatment, patients must undergo a complete radiological assessment including contrast-enhanced CT scans of the thorax and upper abdomen and brain MRI, as per routine care. The study monitors patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, reflecting their ability to carry out daily activities. During the study, researchers will assess progression-free survival from the start of treatment up to 25 months. Patients will be followed through scheduled visits and examinations, including evaluations of clinical status and safety monitoring. Participants are expected to comply with the study protocol throughout the observation period, and data will be collected according to standard care practices in a real-world setting.
Actively Recruiting
Researchers are evaluating whether adding local consolidative radiotherapy to the standard treatment can improve overall survival in patients with metastatic urothelial bladder cancer. The study focuses on patients who have no disease progression and have no more than three remaining distant metastatic lesions after completing first-line systemic therapy. This is a Phase II, multicenter, randomized, open-label trial with a follow-up period of 4 years for each participant. Participants are assigned to receive either standard care alone or standard care combined with consolidative radiotherapy targeting the pelvic area and/or metastatic lesions. Radiotherapy may be combined with previous transurethral resection of bladder tumor as part of the treatment. The study includes patients who have completed 4-6 cycles of first-line systemic therapy, including chemotherapy and/or immunotherapy, and have no progression of disease. Patients who began maintenance therapy are also eligible. During the study, participants will be monitored over 4 years from randomization. Researchers will assess overall survival as the primary outcome. Participants will undergo imaging scans to evaluate metastatic lesions and may be assessed for eligibility for stereotactic body radiotherapy (SBRT) based on dose constraints and prior radiotherapy exposure. The study also involves regular follow-up to monitor disease status and treatment safety.
Actively Recruiting
Researchers are evaluating treatments for low and intermediate risk prostate cancer, focusing on erectile dysfunction. This multicenter study compares two radiation therapies: brachytherapy with Iodine 125 and stereotactic body radiotherapy (SBRT). The study aims to analyze the cost and quality of life differences between these treatments over three years, with additional evaluations up to five years including erectile dysfunction, urinary and gastrointestinal side effects, and overall quality of life. Participants are randomly assigned to one of two groups. One group receives brachytherapy delivering a total of 144 Gy to the prostate using Iodine 125. The other group receives SBRT, which delivers 7.25 Gy in five sessions for a total dose of 36.25 Gy, with small markers implanted in the prostate to guide treatment. About 240 patients will be enrolled over two years from approximately twenty centers. During the study, participants will be monitored for erectile dysfunction, treatment side effects, and quality of life for up to five years after treatment. Researchers will perform cost-utility and cost-effectiveness analyses, including measuring quality adjusted life years and erectile dysfunction avoided. Safety and long-term effects will also be assessed to provide comprehensive information for healthcare decision makers.
Actively Recruiting
Researchers are evaluating whether an early, personalized rehabilitation program that combines nutritional therapy, physiotherapy, and physical activity can improve long-term outcomes for adults who have been critically ill and required mechanical ventilation and vasopressor therapy in the ICU. This trial compares the effects of this extended rehabilitation approach to usual care given during and after ICU stay. The study includes patients starting invasive mechanical ventilation recently and aims to support recovery from critical illness through tailored interventions. Participants are assigned to either the rehabilitation group or the control group. The rehabilitation group receives a customized program beginning early in the ICU and continuing through the post-ICU hospital stay and then at home for a total of 12 weeks. This program uses goal-directed nutrition and physical activity adjusted over time by specialists including dieticians, physiotherapists, and physical-activity instructors. The control group receives the usual care available at each ICU from day 0 to day 180. Throughout the study, participants will be monitored to assess their recovery progress, with the primary outcome measuring the distance walked in 6 minutes at 6 months. Researchers will gather data on physical function and health improvements during and after the rehabilitation period. The study includes follow-up assessments up to 180 days to evaluate the long-term effects of the rehabilitation program compared to usual care.
Actively Recruiting
Patients in intensive care units often require a central venous catheter to deliver medications safely. These catheters, however, can sometimes cause infections, especially the longer they remain in place. Most prevention efforts focus on how the catheter is inserted and handled, but less attention is given to how long the catheter and its connected infusion sets stay in place, which is a key factor in infection risk. This research compares two schedules for changing the infusion sets connected to central venous catheters. One group will have their infusion sets replaced every 7 days, while the other group will follow the usual practice of replacing them every 4 days. During each replacement, all tubing and connectors will be disconnected and swapped with new sterile equipment to reduce contamination risk. Participants will be monitored from catheter insertion until 48 hours after removal, or up to 90 days in the ICU, to track infection rates related to the catheters. Researchers will collect data on infection complications and assess whether the less frequent 7-day replacement increases infection risk compared to the standard 4-day schedule. This study also considers the impacts on nursing workload and medical resource use.
Actively Recruiting
Bronchiectasis is a chronic lung condition where parts of the bronchial tubes become permanently widened, leading to mucus buildup, infections, and ongoing inflammation. Managing this disease often includes respiratory physiotherapy to help clear mucus. However, accessing this therapy regularly can be difficult due to time, location, and availability of trained professionals. Researchers are evaluating the long-term use of the SIMEOX device, which uses brief air pressure pulses to help loosen and move mucus, combined with remote physiotherapy, to improve the quality of life and reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis. The study compares two groups: one using the SIMEOX device daily at home along with remote physiotherapy sessions, and a control group receiving enhanced standard care plus remote physiotherapy. The remote physiotherapy is delivered monthly for the first three months and then every three months afterward. The study lasts on average 24 months, allowing assessment of the device's effects over the mid and long term. Participants will be monitored through quality of life questionnaires and tracking of pulmonary exacerbations during the study. Evaluations include respiratory assessments and ensuring participants can use the device and follow procedures. The main outcomes measured are changes in respiratory quality of life after six months and the annual rate of lung exacerbations over the full study period. Safety and treatment adherence will also be continuously reviewed throughout participation.
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating personalized treatment options for patients with endometrial cancer, focusing on those with p53 abnormal (p53abn) molecular profiles. This Phase III trial is part of the RAINBO program, aiming to improve recurrence-free survival by comparing maintenance treatment with the drug Olaparib to observation after standard chemoradiation therapy. The study includes patients who have completed surgery and standard chemotherapy and radiotherapy treatments. Participants are randomly assigned to receive either Olaparib 300 mg twice daily for one year as maintenance therapy or observation without additional treatment. The trial follows patients who have undergone a specific sequence of chemotherapy and radiotherapy, mainly the PORTEC-3 regimen, or similar alternative regimens as decided by their doctors. The study carefully monitors patients during this maintenance or observation phase to assess the effects of Olaparib compared to no treatment. During the study, patients undergo regular assessments including tumor evaluation before starting maintenance therapy, monitoring of organ function, and follow-up visits to track recurrence-free survival over three years. Researchers evaluate safety, treatment adherence, and overall health, ensuring patients meet all study requirements. The total duration of participation includes the maintenance treatment period and long-term monitoring to observe outcomes and side effects.