Phase III Randomized Trial of Hemithoracic Proton Beam Therapy Versus Standard Surveillance in Unilateral Malignant Pleural Mesothelioma

What this Trial Is About

Researchers are conducting a randomized phase III clinical trial to evaluate treatments for patients with unilateral malignant pleural mesothelioma MPM. The study aims to compare progression-free survival and overall survival between two groups. It also assesses safety, tolerability, quality of life, and local disease control. Patients are grouped based on tumor histology, treatment center, tumor location, and time since diagnosis. Participants are randomly assigned to one of two groups. The experimental group receives proton beam therapy PBT to the hemithorax 50 Gy in 25 daily fractions over five weeks, with a boost to 60 Gy for visible tumors. The control group follows standard care with active surveillance and no immediate treatment. Both groups are monitored for two years after randomization, with clinic visits every three months in the first year and every four months in the second year. If disease progresses in the control group, patients may receive immunotherapy or chemotherapy based on doctor recommendation. During the study, patients undergo evaluations including scans, pulmonary function tests, and quality of life questionnaires. Researchers track adverse events related to proton therapy and collect data on healthcare resource use and informal care. Follow-up occurs at local centers for two years after treatment start. The main outcomes measured are time to disease progression and overall survival, assessing the potential benefits and risks of proton beam therapy for MPM.

Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma