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Found 9 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the use of stereotactic radiotherapy SRT as a treatment strategy for patients with oligoprogressive metastatic renal cell carcinoma RCC who are already undergoing systemic therapies. This phase II study focuses on patients whose cancer has progressed in a limited number of sites despite ongoing treatment, aiming to control local tumors and delay the need for additional systemic therapies. The study builds on evidence that SRT can effectively target RCC metastases and may also stimulate the immune system when combined with immunotherapy. The study involves delivering high-dose stereotactic radiotherapy to metastatic sites showing progression in patients receiving systemic therapies such as targeted drugs or immunotherapy. Eligible patients have 1 to 3 progressing metastases in up to 2 organs, with lesions measuring 4 cm or less, and will continue their current systemic treatment while receiving SRT either concurrently or sequentially. This approach aims to locally control progressing tumors and potentially extend the effectiveness of ongoing therapy. Participants will undergo imaging assessments to confirm disease progression and measure tumor response, with follow-up visits to monitor tumor control and treatment side effects. Researchers will evaluate progression-free survival six months after randomization as the primary outcome, along with local and overall control rates and treatment-related adverse events. The study includes monitoring for safety and effectiveness up to 12 months post-treatment, with participants involvement lasting until at least one month after treatment completion.

Age: 18Years +All GendersPhase 2
30 locations
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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. This study, sponsored by Pfizer, focuses on adults aged 18 years and older who have locally advanced or metastatic ALK-positive NSCLC confirmed by specific diagnostic tests. The goal is to understand how lorlatinib works and its safety profile outside of controlled clinical trial settings. Participants in this study receive lorlatinib as a single agent at a dose of 100 mg taken orally once daily without interruption. The treatment continues as per routine care, and patients undergo thorough radiological evaluations including contrast-enhanced CT scans of the thorax and upper abdomen, as well as brain MRI, before starting lorlatinib. The study monitors various outcomes such as progression-free survival, overall survival, response rates, duration of response, and adverse events over a period of up to 48 months. Throughout the study, participants will have scheduled assessments at regular intervals including clinical evaluations, imaging studies, and questionnaires to track symptoms, treatment adherence, and quality of life. Researchers will also monitor for specific side effects, treatment resistance mechanisms, and changes in patient-reported outcomes related to central nervous system toxicity and overall health status. The total duration of participation includes follow-up visits lasting up to 48 months to gather long-term data on treatment effects and safety.

Age: 18Years +All GendersPhase Not Applicable
31 locations
P

Actively Recruiting

Researchers are evaluating whether adding local consolidative radiotherapy to the standard treatment improves overall survival in patients with metastatic urothelial bladder cancer. This 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. It is a Phase II, randomized, open-label study conducted at multiple centers. Participants will be randomly assigned either to receive standard care alone or to receive consolidative radiotherapy targeting the pelvis andor metastatic sites in addition to standard care. Some patients may have had a previous bladder tumor resection. The radiotherapy is given after the initial systemic treatment phase, which includes chemotherapy andor immunotherapy. The study follows patients for four years from the time of randomization. During the study, patients will have regular assessments including imaging scans to check disease status, toxicity evaluations according to national criteria, and quality of life questionnaires using the EORTC QLQ-C-30 tool. Researchers will monitor overall survival and progression-free survival over four years. Patients must be able to participate and agree to follow the study procedures, and safety is closely observed throughout the trial.

Age: 18Years +All GendersPhase 2
20 locations
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Actively Recruiting

The TEMPOS-GEniToUrinary Group GETUG study is a multicenter, medico-economic trial comparing two radiation treatmentsbrachytherapy and stereotactic body radiotherapy SBRTin men with low and intermediate risk prostate cancer. The study particularly focuses on erectile dysfunction as a key outcome. Researchers aim to evaluate the cost-utility of SBRT compared to standard Iodine 125 brachytherapy over a period of three years after treatment, including secondary analyses on cost-effectiveness and quality of life up to five years. Participants are assigned to one of two treatment groups. The experimental group receives SBRT delivering 7.25 Gy per fraction, given in five doses for a total of 36.25 Gy to the prostate. Fiducials are implanted in the prostate to help guide treatment using Cyberknife or a conventional linear accelerator with tracking systems. The control group receives brachytherapy with Iodine 125, delivering a total dose of 144 Gy to the prostate. The study includes long-term follow-up to assess erectile dysfunction, genito-urinary and gastro-intestinal toxicities, and quality of life up to five years after treatment. Participants will undergo monitoring and assessments throughout the study period, including evaluations of erectile dysfunction and other side effects. The main outcome measured is the incremental cost-utility ratio comparing SBRT to brachytherapy at three years, with further health economic evaluations at five years. The trial plans to recruit about 240 men across multiple centers over two years, with ongoing data collection on treatment impact, side effects, and quality of life to inform future treatment recommendations and health insurance budgeting.

Age: 18Years +MALEPhase Not Applicable
20 locations
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Actively Recruiting

Researchers are evaluating how an early and extended rehabilitation program that combines personalized nutritional therapy, physiotherapy, and physical activity can improve long-term outcomes for patients who have undergone invasive mechanical ventilation and vasopressor therapy in the ICU. This trial compares the effects of this tailored rehabilitation program to usual care, aiming to support recovery from critical illness. The study is a multicenter randomized controlled trial led by Nantes University Hospital. Participants will be assigned randomly to either the rehabilitation group or the usual care group. Those in the rehabilitation group receive a customized program starting early in the ICU and continuing through the post-ICU ward and at home for 12 weeks. This program involves goal-directed nutrition and physical activities adjusted to each patients progress, with support from dieticians, physiotherapists, and physical activity instructors. The usual care group receives standard nutritional support and physiotherapy based on local practices from day 0 to day 180. Throughout the study, participants will undergo various assessments including walking distance measured by a 6-minute walk test at 6 months, muscle strength, muscle mass, physical activity levels, calorie and protein intake, body weight, mortality rates, blood glucose monitoring, and quality of life surveys. These evaluations occur at multiple time points during and after hospitalization, up to one year. The study includes careful monitoring of mechanical ventilation duration, infections, hospital stay lengths, and other safety outcomes. Participant involvement spans from ICU admission through long-term follow-up.

Age: 18Years +All GendersPhase Not Applicable
52 locations
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Actively Recruiting

In intensive care units, patients often need central venous catheters for care and safe medication delivery, but these devices can lead to infections. Most prevention focuses on how catheters are inserted and handled, but the length of time the catheter stays in place is a main source of infection. This research compares changing infusion sets every 7 days versus every 4 days to see if less frequent changes increase infection risk while considering impacts on nursing workload and costs. The study involves two groups one where infusion sets connected to the catheter are replaced every 7 days, and another where they are replaced every 4 days, the current standard recommendation. Each replacement involves disconnecting old sets and replacing them with new sterile ones. Both procedures are performed by qualified nurses during the patients ICU stay. Participants are adult ICU patients with a central venous catheter placed less than 72 hours ago and expected to remain for at least 7 days. Researchers will monitor infections related to the catheter from insertion until 48 hours after removal, along with bloodstream infections, catheter colonization, ICU length of stay, mortality, nursing time, and replacement costs. The study follows patients up to 90 days to collect these outcomes and assess the effects of the different replacement schedules.

Age: 18Years +All GendersPhase Not Applicable
27 locations
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Actively Recruiting

Bronchiectasis is a chronic lung disease involving permanent widening of parts of the airways, leading to mucus buildup, infections, and ongoing inflammation. Researchers are evaluating whether using the SIMEOX device at home, combined with remote physiotherapy, can improve quality of life and reduce lung flare-ups compared to enhanced standard care in patients with non-cystic fibrosis bronchiectasis. This study focuses on long-term effects over about two years. Participants will be randomly assigned to one of two groups one receiving standard care plus remote physiotherapy, and the other using the SIMEOX device daily at home along with remote physiotherapy and standard care. The SIMEOX device delivers short pulses of negative air pressure through a mouthpiece to help loosen and move mucus from the lungs. Remote physiotherapy sessions occur once a month for the first three months and then every three months thereafter. During the study, participants will be monitored for changes in quality of life using questionnaires at 6, 12, and 24 months, and the number of lung exacerbations over about 24 months will be recorded. Lung function tests spirometry will also be conducted periodically. Researchers will track treatment adherence, hospitalizations, and any adverse events. The total study duration per participant is around two years, with regular assessments to evaluate the impact of the SIMEOX device combined with physiotherapy.

Age: 18Years +All GendersPhase Not Applicable
57 locations
N

Actively Recruiting

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.

Age: 18Years +All GendersPhase Not Applicable
83 locations
P

Actively Recruiting

Researchers are investigating personalized treatments for patients with endometrial cancer based on their molecular profiles. This study, part of the RAINBO program, focuses on patients with p53 abnormal endometrial cancer who have completed standard adjuvant chemoradiation therapy. The goal is to see if maintenance treatment with the drug Olaparib can improve recurrence-free survival compared to observation alone. Participants are randomly assigned to either receive Olaparib at a dose of 300 mg twice daily for one year or to be closely observed without additional treatment. All patients have undergone surgery and sequential radiotherapy and chemotherapy, typically following the PORTEC-3 regimen or similar local protocols. The study monitors patients over a three-year period to assess the primary outcome of recurrence-free survival. During the study, participants will have regular assessments including tumor evaluations, organ function tests, and overall health monitoring to ensure safety and treatment adherence. Researchers will also collect data on side effects and disease status throughout the treatment and follow-up periods. The total participation time extends up to three years, including the one-year treatment or observation phase and subsequent monitoring.

Age: 18Years +FEMALEPhase 3
15 locations