Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma

Launched by UNIVERSITY COLLEGE, LONDON · Dec 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called hemithoracic irradiation with proton therapy for patients diagnosed with malignant pleural mesothelioma (MPM), which is a type of cancer affecting the lining of the lungs. The trial aims to determine if this specific type of radiation therapy can help patients whose cancer is only located on one side of the chest and who have not yet started other cancer treatments.

To participate, patients must be at least 18 years old with a confirmed diagnosis of MPM, and their disease should be limited to one side of the chest. Participants will need to agree to regular follow-ups and may have to travel to specific centers for treatment if chosen for the proton therapy group. Throughout the trial, patients will receive close monitoring and support from their healthcare team. This trial is currently looking for new participants, and it’s important for potential participants to discuss their situation with their doctor to see if they meet the eligibility criteria.

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Eligibility criteria

• Inclusion criteria:
• • Patients ≥18 years of age, with histologically (biopsy) confirmed MPM
• • N0 or N1 and M0 disease
• • Written informed consent
• • Patient and responsible clinician opt for active surveillance and deferral of systemic anti-cancer therapy 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
• Exclusion criteria:
• • Presence of metastatic or contralateral disease
• • Prior thoracic radiotherapy, chemotherapy, immunotherapy for MPM
• • Prior radical surgery for MPM (extrapleural pneumonectomy or extended pleurectomy decortication or pleurectomy decortication)
• • Initial systemic therapy or surgery is required and the patient and responsible clinician do not opt for active surveillance
• • Involvement of contralateral or supraclavicular lymph nodes
• • T4 disease with clear invasion of the myocardium
• • N2 and/or M1 disease
• • Presence of new effusion that is not amenable to drainage
• • WHO Performance Status ≥ 2
• • Women who are pregnant or breast feeding
• • History of other malignancy; Exception: (a) Subjects who have been successfully treated and are disease-free for 3 years, (b) a history of treated non-melanoma skin cancer, (c) successfully treated in situ carcinoma, (d) CLL in stable remission, or (e) indolent prostate cancer requiring no or only anti-hormonal therapy.