Status:
RECRUITING
Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma
Lead Sponsor:
University College, London
Collaborating Sponsors:
Asthma + Lung UK
Mesothelioma UK
Conditions:
Malignant Pleural Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Phase III randomised-controlled trial for patients with unilateral malignant pleural mesothelioma (MPM).
Detailed Description
Study design: Randomised phase III clinical trial for patients with unilateral MPM. Primary endpoint: Progression free survival (PFS) and overall survival (OS), defined as the time from randomisation...
Eligibility Criteria
Inclusion criteria:
-
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
Exclusion criteria:
- 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
Key Trial Info
Start Date :
March 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT05655078
Start Date
March 28 2024
End Date
September 30 2029
Last Update
March 30 2026
Active Locations (25)
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1
East Sussex Healthcare NHS Trust - Eastbourne Hospital
Eastbourne, East Sussex, United Kingdom
2
East Sussex Healthcare NHS Trust - Conquest Hospital
Saint Leonards-on-Sea, East Sussex, United Kingdom
3
Royal Berkshire Hospital
Reading, England, United Kingdom, RG15AN
4
Southend University Hospital
Southend, Essex, United Kingdom, SS0 0RY