title: The Mesothelioma and Radical surgery randomized controlled trial: the Mars feasibility study.
abstract: OBJECTIVE
  The effectiveness of extrapleural pneumonectomy (EPP) to extend quality-adjusted survival in malignant pleural mesothelioma within multimodality treatment should be proven in a randomized controlled trial if this radical surgery is to be regarded as the standard of care. The question was whether randomization to surgery versus no surgery would be possible.
  
  
  METHODS
  The Mesothelioma and Radical Surgery trial was planned to randomize 50 patients to test feasibility. There was a two-stage consent process. At first consent, the patients who were possible candidates for radical surgery were registered into the trial for completion of assessment and staging. All received platinum-based chemotherapy. If still eligible, they completed a second consent to be randomized to have either EPP followed by radical hemithorax radiotherapy or to have continued best care.
  
  
  RESULTS
  Patients were recruited through 11 collaborating centers in the United Kingdom. One hundred twelve potentially eligible patients gave informed consent to enter the registration phase and undergo chemotherapy. One died, 27 progressed, five were inoperable, four were treated off trial, and 18 withdrew either during or after chemotherapy but before final review. Additionally six were deemed inoperable at review after completing chemotherapy and one more patient withdrew. The remaining 50 were randomized; 24 to EPP and 26 to continued best care.
  
  
  CONCLUSIONS
  In this study, 50/112 (45%) of patients entering the evaluation and induction phase of the trial went on to be randomized. We have shown that this randomization between surgery and no surgery is feasible. This was the primary aim of the Mesothelioma and Radical Surgery trial.
authors: Guy's and St Thomas' Hospital, London, UK. tom.treasure@gmail.com
authors: Tom
authors: T
authors: Treasure
authors: David
authors: D
authors: Waller
authors: Carol
authors: C
authors: Tan
authors: James
authors: J
authors: Entwisle
authors: Mary
authors: M
authors: O'Brien
authors: Ken
authors: K
authors: O'Byrne
authors: Gill
authors: G
authors: Thomas
authors: Michael
authors: M
authors: Snee
authors: James
authors: J
authors: Spicer
authors: David
authors: D
authors: Landau
authors: Loïc
authors: L
authors: Lang-Lazdunski
authors: Judith
authors: J
authors: Bliss
authors: Clare
authors: C
authors: Peckitt
authors: Shaun
authors: S
authors: Rogers
authors: Erica
authors: E
authors: Marriage Née Denholm
authors: Gillian
authors: G
authors: Coombes
authors: Mark
authors: M
authors: Webster-Smith
authors: Julian
authors: J
authors: Peto
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003131:Combined Modality Therapy; D005240:Feasibility Studies; D006801:Humans; D008654:Mesothelioma / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D010997:Pleural Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D011013:Pneumonectomy; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds