Clinical trial · Interventional
Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma
NCT05655078CI-TRIAL-00106715HIT-MesorecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase III randomised-controlled trial for patients with unilateral malignant pleural mesothelioma (MPM).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Mesothelioma | Pleural Malignant Mesothelioma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton beam therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of care
- description
- 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).
- type
- EXPERIMENTAL
- label
- Proton beam therapy
- description
- 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).
- interventionNames
- Radiation: Proton beam therapy
Primary outcomes (2)
- measure
- Progression free survival
- timeFrame
- From randomisation up to 2 years of follow up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.