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*, L. Darlison, D.A. Fennell, D. Elliott, S. Popat, R.C. Rintoul, D. Waller, C. Ali, A. Bille, A. Ionescu, M. Keni, A. Kirk, P. Koh, T. Mansy, R. Milton, D. Muthukumar, T. Pope, J. Shamash, Z. Tasigiannopoulos, S. TreeceE.A. Stokes, Nicola J Mills

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

10 Citations (Scopus)
17 Downloads (Pure)

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.
Original languageEnglish
Article numbere038892
Number of pages10
JournalBMJ Open
Volume2020
Issue number10
DOIs
Publication statusPublished - 1 Sep 2020

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