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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are investigating treatment options for patients with advanced non-small cell lung cancer (NSCLC), a condition where current outcomes remain poor. This pilot study aims to evaluate the safety and feasibility of adding stereotactic ablative radiotherapy (SABR) to the lung primary tumor before starting standard systemic therapy. The study will focus on patients with stage IV NSCLC who have not yet received systemic therapy, testing whether radiotherapy can be safely delivered and assessing its impact on treatment outcomes. Participants will be randomly assigned to one of two groups: one receiving standard of care (SoC) systemic therapy alone, and the other receiving radiotherapy to the lung primary before the third cycle of systemic therapy. Radiotherapy doses vary depending on tumor location and size, with specific regimens for central, ultracentral, large, and peripheral tumors. Standard systemic therapy includes chemoimmunotherapy combinations such as Pembrolizumab with Carboplatin or Paclitaxel for squamous NSCLC, and Pembrolizumab with Carboplatin or Pemetrexed for non-squamous NSCLC, administered in cycles every three weeks. Throughout the study, participants will undergo regular assessments including radiation toxicity monitoring, adverse event tracking, and CT scans every six weeks to evaluate disease progression. Study visits occur at baseline, radiotherapy (for the radiotherapy group), cycle 3 of systemic therapy, and at 12 and 24 weeks post-treatment initiation. Biospecimens will also be collected for future research. The primary goal is to determine if the study design can proceed to a larger phase III trial without major modifications, with an overall recruitment and follow-up period of 18 months.

Age: 18Years +All GendersPhase 1
6 locations
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Actively Recruiting

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.

Age: 18Years +All GendersPhase 4
264 locations