Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Phase III randomised-controlled trial for patients with unilateral malignant pleural mesothelioma (MPM).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients ≥18 years of age, with histologically (biopsy) confirmed MPM
• N0 or N1 and M0 disease
• Written informed consent
• Patient and responsible clinician opt for active surveillance and deferral of systemic anti-cancer therapy 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
Locations
Other Locations
United Kingdom
Addenbrooke's Hospital
RECRUITING
Cambridge
Velindre Cancer Centre
RECRUITING
Cardiff
Broomfield Hospital
RECRUITING
Chelmsford
Queen Elizabeth Hospital, King's Lynn
RECRUITING
Kings Lynn
St Bartholomew's Hospital
RECRUITING
London
University College London Hospital
RECRUITING
London
Christie Hospital
ACTIVE_NOT_RECRUITING
Manchester
Wythenshawe Hospital
RECRUITING
Manchester
Queen Alexandra Hospital
RECRUITING
Portsmouth
Royal Berkshire Hospital
RECRUITING
Reading
Southend University Hospital
RECRUITING
Southend
Contact Information
Primary
Klara Sinalova
ctc.hit-meso@ucl.ac.uk
020 7679 9826
Backup
Aoife Walker
aoife.walker@ucl.ac.uk
020 3108 5363
Time Frame
Start Date: 2024-03-28
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 148
Treatments
No_intervention: Standard of care
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).
Experimental: Proton beam therapy
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).
Related Therapeutic Areas
Sponsors
Collaborators: Asthma + Lung UK, Mesothelioma UK, University of Sheffield
Leads: University College, London