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NCT05655078
Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma
Conditions: Malignant Pleural Mesothelioma
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 148
Sponsor: University College, London
Summary
Phase III randomised-controlled trial for patients with unilateral malignant pleural mesothelioma (MPM).
Eligibility Criteria
Inclusion Criteria:Histologically (Biopsy) confirmed malignant pleural mesotheliomaNo previous thoracic surgeryT1N1, T2N0, T2N1, T3N0, T3N1 diseaseT4 and T4N1 disease if invasion of chest wall and ribs onlyWHO Performance Status 0-1Age 18 years or overPulmonary Function Tests:40% predicted post-FEV1;40% predicted DLCO (corrected for Hgb)Willing to travel to a proton beam therapy centre for treatment (if randomised to experimental arm)Exclusion Criteria:Presence of metastatic or contralateral disease, prior thoracic radiotherapy, prior radical surgery for MPMNephrectomy on contralateral sidePresence of new effusion that is not amenable to drainT1N0 diseaseT4 disease with invasion to heart and diaphragmM1 diseaseWHO Performance Status ≥ 2Severe, active co-morbidityWomen who are pregnant or breast feeding
Source: ClinicalTrials.gov (NCT05655078). StuddyBuddy aggregates publicly available trial information.