MARS 2: A Feasibility Study Comparing (Extended) Pleurectomy Decortication Versus no Pleurectomy Decortication in Patients With Malignant Pleural Mesothelioma
Conditions
Mesothelioma
Conditions: official terms
Mesothelioma
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: (Extended) pleurectomy decortication
Type: Procedure
Overall Status
Recruiting
Summary
Mesothelioma is a cancer of the thin membrane that lines the chest and abdomen. Around 2300 people in the UK are diagnosed with mesothelioma each year and the average survival is approximately 17 months. Exposure to asbestos is the most common cause although the cancer does not usually become apparent until 30-40 years after exposure. Anti-cancer drugs (chemotherapy) are usually given to help treat mesothelioma and sometimes lung-sparing surgery (pleurectomy decortication) surgery is undertaken. However, it is not known if this surgery, in addition to chemotherapy, can increase survival and improve the quality of life for patients. The aim of the MARS2 study is to determine if it is feasible to enrol patients with mesothelioma into a study randomising them to chemotherapy only or chemotherapy and lung-sparing surgery. Patients will be followed up regularly at their usual clinic visits for to 5 years. Patients will be asked to complete a Quality of Life Questionnaire at these visits. Tissue samples will be taken at the time of diagnosis and at surgery (if they are randomised to surgery) for mesothelioma research central storage and blood samples will be taken at the clinic visits up to 12 months for mesothelioma research central storage. If we can show the feasibility of recruitment we will apply to continue the study to include more patients in order to determine if lung-sparing surgery improves survival and quality of life for mesothelioma patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

- 1. Histological confirmation of mesothelioma, 2. Disease confined to one hemi-thorax.

Exclusion Criteria:

- 1. Unable to give informed consent, 2. Patients unwilling to be randomised, 3. Extent of disease not deemed to be surgically resectable, 4. ECOG status 2 or more, 5. Patients with predicted pre-operative FEV1 or TLco less than 20%, 6. Patients with severe heart failure (EF less than 30%), 7. Patients with end stage kidney failure requiring dialysis, 8. Patients with liver failure, 9. Patients who are participating in another interventional clinical trial.
Locations
Burton Hospitals NHS Foundation Trust
Burton, United Kingdom
Status: Recruiting
Contact: Manjusha Keni
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Status: Recruiting
Contact: Dean Fennell
South Tyneside NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
Status: Recruiting
Contact: Liz Fuller
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Status: Recruiting
Contact: John Edwards
Start Date
May 2015
Completion Date
June 2017
Sponsors
Royal Brompton & Harefield NHS Foundation Trust
Source
Royal Brompton & Harefield NHS Foundation Trust
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page