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NCT05655078Recruiting

Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma

Source: ClinicalTrials.gov · Last updated 30 Mar 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
148 (estimated)
First submitted
11 Nov 2022
Start date
28 Mar 2024
Primary completion date
31 Mar 2029
Lead sponsor
University College, London
NCT number
NCT05655078

What you commit to

  • Study type: Interventional
  • Planned participants: 148
  • From 28 Mar 2024 to the primary completion date, 31 Mar 2029
  • 25 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Patient with prior thoracic / abdominal radiotherapy for malignancy who was not discussed with sponsor before recruitment

Other illness

  • Presence of metastatic or contralateral disease
  • T4 disease with invasion of the myocardium
  • N2 and/or M1 disease
  • Current or previous malignant disease which may impact on the patient's life expectancy
  • 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%

Other

  • Cytological diagnosis and/or undetermined histological subtype
  • Involvement of contralateral or supraclavicular lymph nodes
  • Presence of new effusion that is not amenable to drainage
  • WHO Performance Status ≥ 2
  • Women who are pregnant or breast feeding
  • Patient fitted with a pacemaker or implantable cardioverter-defibrillator (ICD)\\

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Furness General Hospital
Coordinator of this site? Confirm its status
Barrow in FurnessUnited KingdomRecruiting
Betsi Cadwaladr University Health Board - Glan Clwyd Hospital
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BodelwyddanUnited KingdomRecruiting
Southmead Hospital
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BristolUnited KingdomRecruiting
Addenbrooke's Hospital
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CambridgeUnited KingdomRecruiting
Velindre Cancer Centre
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CardiffUnited KingdomRecruiting
Broomfield Hospital
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ChelmsfordUnited KingdomRecruiting
East Sussex Healthcare NHS Trust - Eastbourne Hospital
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EastbourneUnited KingdomRecruiting
Queens Centre, Castle Hill Hospital
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HullUnited KingdomRecruiting
Queen Elizabeth Hospital, King's Lynn
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Kings LynnUnited KingdomRecruiting
Royal Lancaster Hospital
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LancasterUnited KingdomRecruiting
St James University Hospital
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LeedsUnited KingdomRecruiting
Leicester Royal Infirmary
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LeicesterUnited KingdomRecruiting
Clatterbridge Cancer Centre
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LiverpoolUnited KingdomRecruiting
St. Bartholomew's Hospital
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LondonUnited KingdomRecruiting
University College London Hospital
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LondonUnited KingdomRecruiting
Maidstone Hospital
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MaidstoneUnited KingdomRecruiting
Christie Hospital
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ManchesterUnited KingdomActive, not recruiting
Wythenshawe Hospital
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ManchesterUnited KingdomRecruiting
Freeman Hospital
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Newcastle upon TyneUnited KingdomRecruiting
Queen Alexandra Hospital
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PortsmouthUnited KingdomRecruiting
Royal Berkshire Hospital
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ReadingUnited KingdomRecruiting
East Sussex Healthcare NHS Trust - Conquest Hospital
Coordinator of this site? Confirm its status
Saint Leonards-on-SeaUnited KingdomRecruiting
Weston Park Cancer Centre
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SheffieldUnited KingdomRecruiting
Southend University Hospital
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SouthendUnited KingdomRecruiting
Torbay Hospital
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TorquayUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.