Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma

NCT05655078 | Recruiting DMC

• 2 other identifiers: UCL/148232MCTA22F\7
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 25

Brief Summary

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

Conditions

Malignant Pleural Mesothelioma

Keywords

Proton beam therapy

Outcome Measures

Primary Outcomes (2)

• Progression free survival

  Defined as the time from randomisation to the date of disease progression

  From randomisation up to 2 years of follow up

• Overall survival

  defined as the time from randomisation to the date of death from any cause.

  From randomisation up to 2 years of follow up

Secondary Outcomes (5)

• Number of PBT-related adverse events as assessed by CTCAE v5.0

  From start of PBT up to 2 years of follow up, for long term effects

• The EORTC quality of life questionnaire (QLQ), EORTC QLQ-C30 score, scale of 0-100.

  From randomisation up to 2 years of follow up

• ED-5D-5L score

  From randomisation up to 2 years of follow up

• Participant reported healthcare resource use from information collected on Client Service Receipt Inventory (CSRI)

  From randomisation up to 2 years of follow up

• Measurement of costs in economic evaluations using iMTA Valuation of Informal Care (iVICQ) questionnaire

  From randomisation up to 2 years of follow up

Study Arms (2)

Standard of care

NO INTERVENTION

MPM participants who are on the standard of care watch and wait approach i.e. immediate treatment not suitable. Participants will have follow-up for 2 years (3 monthly in year 1, 4 monthly in year 2).

Proton beam therapy

EXPERIMENTAL

MPM participants to receive 5 weeks of proton beam therapy to the hemithorax. Following completion of treatment participants will have follow-up at the referring centre for 2 years (3 monthly in year 1, 4 monthly in year 2).

Radiation: Proton beam therapy

Interventions

Proton beam therapy RADIATION

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).

Proton beam therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• University College, London: lead
• Asthma + Lung UK: collaborator
• Mesothelioma UK: collaborator
• University of Sheffield: collaborator

Study Sites (25)

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, RG15AN, United Kingdom

RECRUITING

Southend University Hospital

Southend, Essex, SS0 0RY, United Kingdom

RECRUITING

Queen Alexandra Hospital

Portsmouth, Hampshire, United Kingdom

RECRUITING

Queen Elizabeth Hospital, King's Lynn

Kings Lynn, Norfolk, PE30 4ET, United Kingdom

RECRUITING

Furness General Hospital

Barrow in Furness, LA14 4LF, United Kingdom

RECRUITING

Betsi Cadwaladr University Health Board -Glan Clwyd Hospital

Bodelwyddan, LL18 5UJ, United Kingdom

RECRUITING

Southmead Hospital

Bristol, BS105NB, United Kingdom

RECRUITING

Addenbrooke's Hospital

Cambridge, CB20QQ, United Kingdom

RECRUITING

Velindre Cancer Centre

Cardiff, United Kingdom

RECRUITING

Broomfield Hospital

Chelmsford, CM1 7ET, United Kingdom

RECRUITING

Queens Centre, Castle Hill Hospital

Hull, HU165JQ, United Kingdom

RECRUITING

Royal Lancaster Hospital

Lancaster, LA1 4RP, United Kingdom

RECRUITING

St James University Hospital

Leeds, LS97TF, United Kingdom

RECRUITING

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

RECRUITING

Clatterbridge Cancer Centre

Liverpool, L78YA, United Kingdom

RECRUITING

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

RECRUITING

University College London Hospital

London, United Kingdom

RECRUITING

Maidstone Hospital

Maidstone, ME169QQ, United Kingdom

RECRUITING

Christie Hospital

Manchester, M20 4BX, United Kingdom

ACTIVE NOT RECRUITING

Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

RECRUITING

Freeman Hospital

Newcastle upon Tyne, NE77DN, United Kingdom

RECRUITING

Weston Park Cancer Centre

Sheffield, S102SJ, United Kingdom

RECRUITING

Torbay Hospital

Torquay, TQ2 7AA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Crispin Hiley

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klara Sinalova

CONTACT

020 7679 9826; ctc.hit-meso@ucl.ac.uk

Aoife Walker

CONTACT

020 3108 5363; aoife.walker@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control arm (standard of care) vs experimental arm (proton beam therapy) in 1:1 randomisation

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: December 16, 2022
• Study Start: March 28, 2024
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (25)