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Researchers are evaluating a phase III randomized clinical trial for patients with unilateral malignant pleural mesothelioma (MPM). The study aims to compare progression-free survival and overall survival between two approaches: proton beam therapy and standard surveillance. Patients will be stratified based on tumor histology, treatment center, tumor side, and time since diagnosis to assess these outcomes. Participants in the experimental group will receive proton beam therapy targeted at the hemithorax, delivering a total dose of 50Gy in 25 daily fractions over five weeks, with an additional boost to 60Gy for visible tumors. The control group will undergo standard care surveillance without immediate treatment, with immunotherapy or chemotherapy offered if disease progression occurs. Both groups will be followed for two years from randomization. During the study, patients will have regular follow-up visits at their local trial sites for assessments including safety, tolerability, quality of life questionnaires, and disease monitoring. The main outcomes measured are progression-free survival and overall survival up to two years. The study plans to recruit 148 patients across 20 UK centers, with additional interim analyses to evaluate treatment efficacy and safety throughout the trial period.

Age: 18Years +All GendersPhase Not Applicable
25 locations
Barrow In Furness Clinical Trials | DecenTrialz