TY - JOUR T1 - 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 JF - BMJ Open JO - BMJ Open DO - 10.1136/bmjopen-2020-038892 VL - 10 IS - 9 SP - e038892 AU - Eric Lim AU - Liz Darlison AU - John Edwards AU - Daisy Elliott AU - D A Fennell AU - Sanjay Popat AU - Robert C Rintoul AU - David Waller AU - Clinton Ali AU - Andrea Bille AU - Liz Fuller AU - Andreea Ionescu AU - Manjusha Keni AU - Alan Kirk AU - Pek Koh AU - Kelvin Lau AU - Talal Mansy AU - Nick A Maskell AU - Richard Milton AU - Dakshinamoorthy Muthukumar AU - Tony Pope AU - Amy Roy AU - Riyaz Shah AU - Jonathan Shamash AU - Zacharias Tasigiannopoulos AU - Paul Taylor AU - Sarah Treece AU - Kate Ashton AU - Rosie Harris AU - Katherine Joyce AU - Barbara Warnes AU - Nicola Mills AU - Elizabeth A Stokes AU - Chris Rogers A2 - , Y1 - 2020/08/01 UR - http://bmjopen.bmj.com/content/10/9/e038892.abstract N2 - 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. ER -