Actively Recruiting
Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma
Led by University College, London · Updated on 2026-03-30
148
Participants Needed
25
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
A
Asthma + Lung UK
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older with biopsy-confirmed malignant pleural mesothelioma and histological subtyping (epithelioid or non-epithelioid)
- Disease classified as N0 or N1 and M0
- Written informed consent provided
- Patient and local/regional multidisciplinary team opt for active surveillance and delay systemic anti-cancer therapy until progression
- WHO Performance Status of 0 or 1
- Disease confined to one hemithorax confirmed by CT scan
- Adequate lung function: predicted post-FEV1 ≥ 40% and predicted DLCO/TLCO ≥ 40%
- Agreement to travel to proton beam therapy centers if assigned to treatment
- Agreement to follow-up at a local HIT-Meso trial site
- Patient likely able to complete proton beam therapy planning based on local assessment
You will not qualify if you...
- Presence of metastatic or contralateral disease
- Diagnosis by cytology only or undetermined histological subtype
- Prior thoracic radiotherapy, chemotherapy, or immunotherapy for malignant pleural mesothelioma
- Prior radical surgery for malignant pleural mesothelioma (extrapleural pneumonectomy or extended pleurectomy decortication or pleurectomy decortication)
- Need for initial systemic therapy or surgery without opting for active surveillance
- Involvement of contralateral or supraclavicular lymph nodes
- T4 disease with myocardium invasion
- N2 and/or M1 disease
- New pleural effusion not suitable for drainage
- WHO Performance Status of 2 or higher
- Pregnant or breastfeeding women
- Current or past malignant disease affecting life expectancy
- Presence of pacemaker or implantable cardioverter-defibrillator
- Diagnosis of significant interstitial lung disease, excluding mild fibrosis or incidental findings
- Chronic non-malignant disease with less than 20% estimated 3-year survival
- Prior thoracic or abdominal radiotherapy for malignancy without prior discussion with study sponsor
Research Team
K
Klara Sinalova
A
Aoife Walker
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