Status:

RECRUITING

Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma

Lead Sponsor:

University College, London

Collaborating Sponsors:

Asthma + Lung UK

Mesothelioma UK

Conditions:

Malignant Pleural Mesothelioma

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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

Detailed Description

Study design: Randomised phase III clinical trial for patients with unilateral MPM. Primary endpoint: Progression free survival (PFS) and overall survival (OS), defined as the time from randomisation...

Eligibility Criteria

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

Key Trial Info

Start Date :

March 28 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 30 2029

Estimated Enrollment :

148 Patients enrolled

Trial Details

Trial ID

NCT05655078

Start Date

March 28 2024

End Date

September 30 2029

Last Update

March 30 2026

Active Locations (25)

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Page 1 of 7 (25 locations)

1

East Sussex Healthcare NHS Trust - Eastbourne Hospital

Eastbourne, East Sussex, United Kingdom

2

East Sussex Healthcare NHS Trust - Conquest Hospital

Saint Leonards-on-Sea, East Sussex, United Kingdom

3

Royal Berkshire Hospital

Reading, England, United Kingdom, RG15AN

4

Southend University Hospital

Southend, Essex, United Kingdom, SS0 0RY

Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma | DecenTrialz