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New treatment option for Malignant Pleural Mesothelioma
Official title Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma
ClinicalTrials.gov ID: NCT05655078
What this study is testing
- What it's testing
- Phase III randomised-controlled trial for patients with unilateral malignant pleural mesothelioma (MPM).
- Time commitment: about 5 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility 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 assigned by chance 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Eastbourne, East Sussex, United Kingdom
- Saint Leonards-on-Sea, East Sussex, United Kingdom
- Reading, England, United Kingdom
- Southend, Essex, United Kingdom
- Portsmouth, Hampshire, United Kingdom
- Kings Lynn, Norfolk, United Kingdom
- Barrow in Furness, United Kingdom
- Bodelwyddan, United Kingdom
- Bristol, United Kingdom
- Cambridge, United Kingdom
- Cardiff, United Kingdom
- Chelmsford, United Kingdom
- Hull, United Kingdom
- Lancaster, United Kingdom
- Leeds, United Kingdom
- Leicester, United Kingdom
- Liverpool, United Kingdom
- London, United Kingdom
- Maidstone, United Kingdom
- Manchester, United Kingdom
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Eastbourne, East Sussex, United Kingdom; Saint Leonards-on-Sea, East Sussex, United Kingdom; Reading, England, United Kingdom; Southend, Essex, United Kingdom; Portsmouth, Hampshire, United Kingdom; Kings Lynn, Norfolk, United Kingdom and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.