Phase III randomised-controlled trial for patients with unilateral malignant pleural mesothelioma (MPM).
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
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 extended pleurectomy decortication or pleurectomy decortication)
Parallel
Proton beam therapy
Radiation5 weeks (Mon-Fri) of proton beam treatment to the hemithorax to a dose of 50Gy in 25 fractions with a boost to 60Gy for the visible tumour (gross tumour volume-GTV).
Progression free survival
Defined as the time from randomisation to the date of disease progression
Overall survival
defined as the time from randomisation to the date of death from any cause.
Number of PBT-related adverse events as assessed by CTCAE v5.0
AEs related to proton beam therapy will be collected
The EORTC quality of life questionnaire (QLQ), EORTC QLQ-C30 score, scale of 0-100.
Participant reported quality of life outcomes. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / quality of life (QoL scale), and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
ED-5D-5L score
Participant reported quality of life outcomes. The questionnaire comprises descriptive systems: mobility, self care, usual activities, pain/discomfort, anxiety/depression; scored from, level 1 to 5; level 1 indicating no problem and level 5 indicating unable to/extreme problems. There is also a scale from 0-100 to describe health status, 100 being the best health the patient can imagine, 0 being the worst health they can imagine.
Participant reported healthcare resource use from information collected on Client Service Receipt Inventory (CSRI)
A tool used to collect participant reported information on the range of healthcare services and supports study participants may use, to calculate the rate of service usage to evaluate resource use as part of health economic analysis.
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University College, London
Lead sponsor
Asthma + Lung UK
Collaborator
Mesothelioma UK
Collaborator
University of Sheffield
Collaborator
