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RECRUITINGINTERVENTIONAL

Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Patients ≥18 years of age, with biopsy confirmed MPM and histological subtyping (epithelioid or non-epithelioid) - N0 or N1 and M0 disease - Written willing to sign a consent form - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

RADIATION

Proton beam therapy

5 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).

Locations (20)

East Sussex Healthcare NHS Trust - Eastbourne Hospital
Eastbourne, East Sussex, United Kingdom
East Sussex Healthcare NHS Trust - Conquest Hospital
Saint Leonards-on-Sea, East Sussex, United Kingdom
Royal Berkshire Hospital
Reading, England, United Kingdom
Southend University Hospital
Southend, Essex, United Kingdom
Queen Alexandra Hospital
Portsmouth, Hampshire, United Kingdom
Queen Elizabeth Hospital, King's Lynn
Kings Lynn, Norfolk, United Kingdom
Furness General Hospital
Barrow in Furness, United Kingdom
Betsi Cadwaladr University Health Board -Glan Clwyd Hospital
Bodelwyddan, United Kingdom
Southmead Hospital
Bristol, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Broomfield Hospital
Chelmsford, United Kingdom
Queens Centre, Castle Hill Hospital
Hull, United Kingdom
Royal Lancaster Hospital
Lancaster, United Kingdom
St James University Hospital
Leeds, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Clatterbridge Cancer Centre
Liverpool, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
University College London Hospital
London, United Kingdom
Maidstone Hospital
Maidstone, United Kingdom