Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma
Recruiting · NCT05655078 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Proton beam therapy
What this trial is about
Phase III randomised-controlled trial for patients with unilateral malignant pleural mesothelioma (MPM).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
25 locations listed.
- Furness General Hospital - Barrow in Furness, United Kingdom
- Betsi Cadwaladr University Health Board -Glan Clwyd Hospital - Bodelwyddan, United Kingdom
- Southmead Hospital - Bristol, United Kingdom
- Addenbrooke's Hospital - Cambridge, United Kingdom
- Velindre Cancer Centre - Cardiff, United Kingdom
- Broomfield Hospital - Chelmsford, United Kingdom
- Queens Centre, Castle Hill Hospital - Hull, United Kingdom
- Royal Lancaster Hospital - Lancaster, United Kingdom
- St James University Hospital - Leeds, United Kingdom
- Leicester Royal Infirmary - Leicester, United Kingdom
- Clatterbridge Cancer Centre - Liverpool, United Kingdom
- St Bartholomew's Hospital - London, United Kingdom
- University College London Hospital - London, United Kingdom
- Maidstone Hospital - Maidstone, United Kingdom
- Christie Hospital - Manchester, United Kingdom
- Wythenshawe Hospital - Manchester, United Kingdom
- Freeman Hospital - Newcastle upon Tyne, United Kingdom
- Weston Park Cancer Centre - Sheffield, United Kingdom
- Torbay Hospital - Torquay, United Kingdom
- East Sussex Healthcare NHS Trust - Eastbourne Hospital - Eastbourne, East Sussex, United Kingdom
- East Sussex Healthcare NHS Trust - Conquest Hospital - Saint Leonards-on-Sea, East Sussex, United Kingdom
- Royal Berkshire Hospital - Reading, England, United Kingdom
- Southend University Hospital - Southend, Essex, United Kingdom
- Queen Alexandra Hospital - Portsmouth, Hampshire, United Kingdom
- Queen Elizabeth Hospital, King's Lynn - Kings Lynn, Norfolk, United Kingdom