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Recruiting NCT05655078

Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma

Trial Parameters

Condition Malignant Pleural Mesothelioma
Sponsor University College, London
Study Type INTERVENTIONAL
Phase N/A
Enrollment 148
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-03-28
Completion 2029-03-31
Interventions
Proton beam therapy

Brief Summary

Phase III randomised-controlled trial for patients with unilateral malignant pleural mesothelioma (MPM).

Eligibility Criteria

Inclusion criteria: * Patients ≥18 years of age, with biopsy confirmed MPM and histological subtyping (epithelioid or non-epithelioid) * N0 or N1 and M0 disease * Written informed consent * Patient and local/regional MDT opt for active surveillance and deferral of SACT until clinical or radiological progression * WHO Performance Status 0-1 * Disease confined to one hemithorax based on CT assessment * Adequate pulmonary function * ≥ 40% predicted post-FEV1; * ≥ 40% predicted DLCO/TLCO * Agreement to travel to either proton beam therapy centres (i.e. UCLH or The Christie) if randomised to arm 2 * Agreement to be followed up at a local HIT-Meso trial site * Patient likely able to complete PBT planning based on local assessment Exclusion criteria: * Presence of metastatic or contralateral disease * Cytological diagnosis and/or undetermined histological subtype * Prior thoracic radiotherapy, chemotherapy, immunotherapy for MPM * Prior radical surgery for MPM (extrapleural pneumonectomy or e

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