Mesothelioma and Radical Surgery 2 (MARS 2): protocol for a multicentre randomised trial comparing (extended) pleurectomy decortication versus no (extended) pleurectomy decortication for patients with malignant pleural mesothelioma

Eric Lim, Liz Darlison, John Edwards, Daisy Elliott, D. A. Fennell, Sanjay Popat, Robert C. Rintoul, David Waller, Clinton Ali, Andrea Bille, Liz Fuller, Andreea Ionescu, Manjusha Keni, Alan Kirk, Pek Koh, Kelvin Lau, Talal Mansy, Nick A. Maskell, Richard Milton, Dakshinamoorthy MuthukumarTony Pope, Amy Roy, Riyaz Shah, Jonathan Shamash, Zacharias Tasigiannopoulos, Paul Taylor, Sarah Treece, Kate Ashton, Rosie Harris, Katherine Joyce, Barbara Warnes, Nicola Mills, Elizabeth A. Stokes, Chris Rogers, MARS 2 Trialists

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18 Citations (Scopus)

Abstract

Introduction: Mesothelioma remains a lethal cancer. To date, systemic therapy with pemetrexed and a platinum drug remains the only licensed standard of care. As the median survival for patients with mesothelioma is 12.1 months, surgery is an important consideration to improve survival and/or quality of life. Currently, only two surgical trials have been performed which found that neither extensive (extra-pleural pneumonectomy) or limited (partial pleurectomy) surgery improved survival (although there was some evidence of improved quality of life). Therefore, clinicians are now looking to evaluate pleurectomy decortication, the only radical treatment option left.

Methods and analysis: The MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery—(extended) pleurectomy decortication—versus no surgery for the treatment of pleural mesothelioma. The study will test the hypothesis that surgery and chemotherapy is superior to chemotherapy alone with respect to overall survival. Secondary outcomes include health-related quality of life, progression-free survival, measures of safety (adverse events) and resource use to 2 years. The QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.

Ethics and dissemination: Research ethics approval was granted by London – Camberwell St. Giles Research Ethics Committee (reference 13/LO/1481) on 7 November 2013. We will submit the results for publication in a peer-reviewed journal.

Trial registration numbers: ISRCTN—ISRCTN44351742 and ClinicalTrials.gov—NCT02040272.
Original languageEnglish
Article numbere038892
JournalBMJ Open
Volume10
Issue number9
DOIs
Publication statusPublished - 1 Sep 2020

Keywords

  • chemotherapy
  • oncology
  • thoracic medicine
  • thoracic surgery

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