Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05655078

Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma

Led by University College, London · Updated on 2026-03-30

148

Participants Needed

25

Research Sites

287 weeks

Total Duration

On this page

Sponsors

U

University College, London

Lead Sponsor

A

Asthma + Lung UK

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years of age or older with biopsy-confirmed malignant pleural mesothelioma and histological subtyping (epithelioid or non-epithelioid)
  • N0 or N1 and M0 disease stage
  • Written informed consent provided
  • Patient and local/regional multidisciplinary team choose active surveillance and delay systemic anti-cancer therapy until progression
  • WHO Performance Status of 0 or 1
  • Disease confined to one hemithorax based on CT scan
  • Adequate lung function with predicted post-bronchodilator FEV1 of at least 40% and DLCO/TLCO of at least 40%
  • Agreement to travel to proton beam therapy centers (UCLH or The Christie) if randomized to experimental arm
  • Agreement to follow-up at a local HIT-Meso trial site
  • Patient likely able to complete proton beam therapy planning based on assessment
Not Eligible

You will not qualify if you...

  • Presence of metastatic or disease on opposite side of chest
  • Cytological diagnosis only or unclear histological subtype
  • Prior thoracic radiotherapy, chemotherapy, or immunotherapy for malignant pleural mesothelioma
  • Prior radical surgery for malignant pleural mesothelioma (including extrapleural pneumonectomy or pleurectomy decortication)
  • Need for initial systemic therapy or surgery when not opting for active surveillance
  • Involvement of opposite side or supraclavicular lymph nodes
  • T4 disease with heart invasion
  • N2 and/or M1 disease
  • New pleural effusion that cannot be drained
  • WHO Performance Status of 2 or higher
  • Pregnancy or breastfeeding
  • Current or previous cancer that may affect life expectancy
  • Presence of a pacemaker or implantable cardioverter-defibrillator
  • Clinically significant interstitial lung disease excluding mild fibrosis or incidental findings
  • Chronic non-cancer diseases with less than 20% estimated survival at 3 years
  • Prior thoracic or abdominal radiotherapy for cancer without prior discussion with sponsor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 25 locations

1

East Sussex Healthcare NHS Trust - Eastbourne Hospital

Eastbourne, East Sussex, United Kingdom

Actively Recruiting

2

East Sussex Healthcare NHS Trust - Conquest Hospital

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

Actively Recruiting

3

Royal Berkshire Hospital

Reading, England, United Kingdom, RG15AN

Actively Recruiting

4

Southend University Hospital

Southend, Essex, United Kingdom, SS0 0RY

Actively Recruiting

5

Queen Alexandra Hospital

Portsmouth, Hampshire, United Kingdom

Actively Recruiting

6

Queen Elizabeth Hospital, King's Lynn

Kings Lynn, Norfolk, United Kingdom, PE30 4ET

Actively Recruiting

7

Furness General Hospital

Barrow in Furness, United Kingdom, LA14 4LF

Actively Recruiting

8

Betsi Cadwaladr University Health Board -Glan Clwyd Hospital

Bodelwyddan, United Kingdom, LL18 5UJ

Actively Recruiting

9

Southmead Hospital

Bristol, United Kingdom, BS105NB

Actively Recruiting

10

Addenbrooke's Hospital

Cambridge, United Kingdom, CB20QQ

Actively Recruiting

11

Velindre Cancer Centre

Cardiff, United Kingdom

Actively Recruiting

12

Broomfield Hospital

Chelmsford, United Kingdom, CM1 7ET

Actively Recruiting

13

Queens Centre, Castle Hill Hospital

Hull, United Kingdom, HU165JQ

Actively Recruiting

14

Royal Lancaster Hospital

Lancaster, United Kingdom, LA1 4RP

Actively Recruiting

15

St James University Hospital

Leeds, United Kingdom, LS97TF

Actively Recruiting

16

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Actively Recruiting

17

Clatterbridge Cancer Centre

Liverpool, United Kingdom, L78YA

Actively Recruiting

18

St Bartholomew's Hospital

London, United Kingdom, EC1A 7BE

Actively Recruiting

19

University College London Hospital

London, United Kingdom

Actively Recruiting

20

Maidstone Hospital

Maidstone, United Kingdom, ME169QQ

Actively Recruiting

21

Christie Hospital

Manchester, United Kingdom, M20 4BX

Active, Not Recruiting

22

Wythenshawe Hospital

Manchester, United Kingdom, M23 9LT

Actively Recruiting

23

Freeman Hospital

Newcastle upon Tyne, United Kingdom, NE77DN

Actively Recruiting

24

Weston Park Cancer Centre

Sheffield, United Kingdom, S102SJ

Actively Recruiting

25

Torbay Hospital

Torquay, United Kingdom, TQ2 7AA

Actively Recruiting

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Research Team

K

Klara Sinalova

CONTACT

A

Aoife Walker

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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