Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma

Summary

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

Eligibility

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 extended pleurectomy decortication or pleurectomy decortication)
* Initial systemic therapy or surgery is required and the patient and local/regional MDT do not opt for active surveillance
* Involvement of contralateral or supraclavicular lymph nodes
* T4 disease with 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
* Current or previous malignant disease which may impact on the patient's life expectancy
* Patient fitted with a pacemaker or implantable cardioverter-defibrillator (ICD)\\
* Diagnosis of clinically significant interstitial lung disease (ILD), excluding mild fibrosis or incidental findings
* Chronic non-malignant disease with an estimated three-year survival rate of less than 20%
* Patient with prior thoracic / abdominal radiotherapy for malignancy who was not discussed with sponsor before recruitment

Conditions3

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