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Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma

Status: Recruiting
Location: See all (25) 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 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

Locations
Other Locations
United Kingdom
Furness General Hospital
RECRUITING
Barrow In Furness
Betsi Cadwaladr University Health Board -Glan Clwyd Hospital
RECRUITING
Bodelwyddan
Southmead Hospital
RECRUITING
Bristol
Addenbrooke's Hospital
RECRUITING
Cambridge
Velindre Cancer Centre
RECRUITING
Cardiff
Broomfield Hospital
RECRUITING
Chelmsford
East Sussex Healthcare NHS Trust - Eastbourne Hospital
RECRUITING
Eastbourne
Queens Centre, Castle Hill Hospital
RECRUITING
Hull
Queen Elizabeth Hospital, King's Lynn
RECRUITING
Kings Lynn
Royal Lancaster Hospital
RECRUITING
Lancaster
St James University Hospital
RECRUITING
Leeds
Leicester Royal Infirmary
RECRUITING
Leicester
Clatterbridge Cancer Centre
RECRUITING
Liverpool
St Bartholomew's Hospital
RECRUITING
London
University College London Hospital
RECRUITING
London
Maidstone Hospital
RECRUITING
Maidstone
Christie Hospital
ACTIVE_NOT_RECRUITING
Manchester
Wythenshawe Hospital
RECRUITING
Manchester
Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Queen Alexandra Hospital
RECRUITING
Portsmouth
Royal Berkshire Hospital
RECRUITING
Reading
East Sussex Healthcare NHS Trust - Conquest Hospital
RECRUITING
Saint Leonards-on-sea
Weston Park Cancer Centre
RECRUITING
Sheffield
Southend University Hospital
RECRUITING
Southend
Torbay Hospital
RECRUITING
Torquay
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

This content was sourced from clinicaltrials.gov

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