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
- Diseases
- Mesothelioma, Lung cancer
- 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
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Furness General Hospital Coordinator of this site? Confirm its status | Barrow in Furness | United Kingdom | Recruiting |
| Betsi Cadwaladr University Health Board - Glan Clwyd Hospital Coordinator of this site? Confirm its status | Bodelwyddan | United Kingdom | Recruiting |
| Southmead Hospital Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| Velindre Cancer Centre Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Recruiting |
| Broomfield Hospital Coordinator of this site? Confirm its status | Chelmsford | United Kingdom | Recruiting |
| East Sussex Healthcare NHS Trust - Eastbourne Hospital Coordinator of this site? Confirm its status | Eastbourne | United Kingdom | Recruiting |
| Queens Centre, Castle Hill Hospital Coordinator of this site? Confirm its status | Hull | United Kingdom | Recruiting |
| Queen Elizabeth Hospital, King's Lynn Coordinator of this site? Confirm its status | Kings Lynn | United Kingdom | Recruiting |
| Royal Lancaster Hospital Coordinator of this site? Confirm its status | Lancaster | United Kingdom | Recruiting |
| St James University Hospital Coordinator of this site? Confirm its status | Leeds | United Kingdom | Recruiting |
| Leicester Royal Infirmary Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
| Clatterbridge Cancer Centre Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Recruiting |
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| University College London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Maidstone Hospital Coordinator of this site? Confirm its status | Maidstone | United Kingdom | Recruiting |
| Christie Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Active, not recruiting |
| Wythenshawe Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Freeman Hospital Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
| Queen Alexandra Hospital Coordinator of this site? Confirm its status | Portsmouth | United Kingdom | Recruiting |
| Royal Berkshire Hospital Coordinator of this site? Confirm its status | Reading | United Kingdom | Recruiting |
| East Sussex Healthcare NHS Trust - Conquest Hospital Coordinator of this site? Confirm its status | Saint Leonards-on-Sea | United Kingdom | Recruiting |
| Weston Park Cancer Centre Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Southend University Hospital Coordinator of this site? Confirm its status | Southend | United Kingdom | Recruiting |
| Torbay Hospital Coordinator of this site? Confirm its status | Torquay | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.