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MARS 2: A Feasibility Study Comparing (Extended) Pleurectomy Decortication Versus no Pleurectomy Decortication in Patients With Malignant Pleural Mesothelioma (MARS2)

Published: January 24, 2014

Primary Outcome Measures:

Ability to randomise 50 patients [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Ability to randomise 50 patients within the first 24 months or the ability to recruit 25 patients within any 6 month period

Secondary Outcome Measures:

Survival from the time point of randomisation [ Time Frame: Follow up for up to 5 years ] [ Designated as safety issue: Yes ]

Quality of life as assessed using QLQ 30 and LC-13 scales [ Time Frame: Follow up for up to 5 years ] [ Designated as safety issue: No ]

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.
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