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MARS 2: A Feasibility Study Comparing (Extended) Pleurectomy Decortication Versus no Pleurectomy Decortication in Patients With Malignant Pleural Mesothelioma

Brief 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.

Tracking Information
First Received DateDecember 20, 2013
Last Changed DateMay 11, 2017
Start DateMay 2015
Anticipated Primary Completion DateMay 2017
Primary Outcome Measures

Ability to randomise 50 patients [Time Frame: 24 months]

Secondary Outcome Measures

Survival from the time point of randomisation [Time Frame: Follow up for up to 5 years]

Quality of life as assessed using QLQ 30 and LC-13 scales [Time Frame: Follow up for up to 5 years]

Descriptive Information
PhaseN/A
Study TypeInterventional
Condition
  • Mesothelioma
Intervention
  • Procedure: (Extended) pleurectomy decortication
Study Arms / Comparison Groups2 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment50
GenderAll
AgesN/A - N/A
Accepts Healthy VolunteersNo
Contact Eric Lim
Email: e.lim@rbht.nhs.uk
Eligibility 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.

Administrative Information
NCTIDNCT02040272
Responsible Party,
SponsorRoyal Brompton & Harefield NHS Foundation Trust
Verification DateMay 2017
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