Proton therapy for treating malignant pleural mesothelioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized phase III trial designed for patients with unilateral malignant pleural mesothelioma (MPM). Participants will be randomly assigned to receive either proton beam therapy (PBT) targeting the hemithorax or standard care with active surveillance. The primary endpoints include progression-free survival and overall survival, while secondary endpoints assess safety, tolerability, and quality of life. Patients will be followed for two years post-randomization to evaluate treatment outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• East Sussex Healthcare NHS Trust - Eastbourne Hospital
  Eastbourne, East Sussex, United Kingdom Recruiting
• East Sussex Healthcare NHS Trust - Conquest Hospital
  Saint Leonards-on-Sea, East Sussex, United Kingdom Recruiting
• Royal Berkshire Hospital
  Reading, England, United Kingdom Recruiting
• Southend University Hospital
  Southend, Essex, United Kingdom Recruiting
• Queen Alexandra Hospital
  Portsmouth, Hampshire, United Kingdom Recruiting
• Queen Elizabeth Hospital, King's Lynn
  Kings Lynn, Norfolk, United Kingdom Recruiting

Study contacts

• Principal investigator: Crispin Hiley — University College, London
• Study coordinator: Klara Sinalova
• Email: ctc.hit-meso@ucl.ac.uk
• Phone: 020 7679 9826

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.