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โ† Trials
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Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma

RecruitingNAAges 18 Years - anyAllUniversity College, London
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: * Patients โ‰ฅ18 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 * โ‰ฅ 40% predicted post-FEV1; * โ‰ฅ 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 โ‰ฅ 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
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What it tests

  • Proton beam therapy
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Where

25 sites
East Sussex Healthcare NHS Trust - Eastbourne Hospital
Eastbourne, United Kingdom
East Sussex Healthcare NHS Trust - Conquest Hospital
Saint Leonards-on-Sea, United Kingdom
Royal Berkshire Hospital
Reading, United Kingdom
Southend University Hospital
Southend, United Kingdom
Queen Alexandra Hospital
Portsmouth, United Kingdom
Queen Elizabeth Hospital, King's Lynn
Kings Lynn, United Kingdom
Furness General Hospital
Barrow in Furness, United Kingdom
Betsi Cadwaladr University Health Board -Glan Clwyd Hospital
Bodelwyddan, United Kingdom

โ€ฆand 17 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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