Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma
Recruiting now · Not applicable
Conditions studied: Malignant Pleural Mesothelioma
In brief
Phase III randomised-controlled trial for patients with unilateral malignant pleural mesothelioma (MPM).
Key facts
- Study ID
- NCT05655078
- Run by
- University College, London
- People needed
- 148
- Starts
- 2024-03-28
- Expected to finish
- 2029-09-30
- Last updated by the study team
- 2026-03-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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%
- Patient with prior thoracic / abdominal radiotherapy for malignancy who was not discussed with sponsor before recruitment
Where it is running
- Torbay Hospital — Torquay, United Kingdom (enrolling)
- East Sussex Healthcare NHS Trust - Conquest Hospital — Saint Leonards-on-Sea, East Sussex, United Kingdom (enrolling)
- Royal Berkshire Hospital — Reading, England, United Kingdom (enrolling)
- Southend University Hospital — Southend, Essex, United Kingdom (enrolling)
- Queen Alexandra Hospital — Portsmouth, Hampshire, United Kingdom (enrolling)
- Queen Elizabeth Hospital, King's Lynn — Kings Lynn, Norfolk, United Kingdom (enrolling)
- Furness General Hospital — Barrow in Furness, United Kingdom (enrolling)
- Betsi Cadwaladr University Health Board -Glan Clwyd Hospital — Bodelwyddan, United Kingdom (enrolling)
- Southmead Hospital — Bristol, United Kingdom (enrolling)
- Addenbrooke's Hospital — Cambridge, United Kingdom (enrolling)
- Velindre Cancer Centre — Cardiff, United Kingdom (enrolling)
- Broomfield Hospital — Chelmsford, United Kingdom (enrolling)
- Queens Centre, Castle Hill Hospital — Hull, United Kingdom (enrolling)
- Royal Lancaster Hospital — Lancaster, United Kingdom (enrolling)
- St James University Hospital — Leeds, United Kingdom (enrolling)
- Leicester Royal Infirmary — Leicester, United Kingdom (enrolling)
- Clatterbridge Cancer Centre — Liverpool, United Kingdom (enrolling)
- St Bartholomew's Hospital — London, United Kingdom (enrolling)
- University College London Hospital — London, United Kingdom (enrolling)
- Maidstone Hospital — Maidstone, United Kingdom (enrolling)
- East Sussex Healthcare NHS Trust - Eastbourne Hospital — Eastbourne, East Sussex, United Kingdom (enrolling)
- Wythenshawe Hospital — Manchester, United Kingdom (enrolling)
- Freeman Hospital — Newcastle upon Tyne, United Kingdom (enrolling)
- Weston Park Cancer Centre — Sheffield, United Kingdom (enrolling)
- Christie Hospital — Manchester, United Kingdom
Full record on ClinicalTrials.gov
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