NCT05655078 Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma
| NCT ID | NCT05655078 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College, London |
| Condition | Malignant Pleural Mesothelioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2024-03-28 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 148 participants in total. It began in 2024-03-28 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Phase III randomised-controlled trial for patients with unilateral malignant pleural mesothelioma (MPM).
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
Contact & Investigator
Crispin Hiley
PRINCIPAL INVESTIGATOR
University College, London
Frequently Asked Questions
Who can join the NCT05655078 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Pleural Mesothelioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05655078 currently recruiting?
Yes, NCT05655078 is actively recruiting participants. Contact the research team at ctc.hit-meso@ucl.ac.uk for enrollment information.
Where is the NCT05655078 trial being conducted?
This trial is being conducted at Eastbourne, United Kingdom, Saint Leonards-on-Sea, United Kingdom, Reading, United Kingdom, Southend, United Kingdom and 11 additional locations.
Who is sponsoring the NCT05655078 clinical trial?
NCT05655078 is sponsored by University College, London. The principal investigator is Crispin Hiley at University College, London. The trial plans to enroll 148 participants.