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. Issue 9 (1st September 2020)

• Record Type: Journal Article
• Authors: Lim, Eric; Darlison, Liz; Edwards, John; Elliott, Daisy; Fennell, D A; Popat, Sanjay; Rintoul, Robert C; Waller, David; Ali, Clinton; Bille, Andrea; Fuller, Liz; Ionescu, Andreea; Keni, Manjusha; Kirk, Alan; Koh, Pek; Lau, Kelvin; Mansy, Talal; Maskell, Nick A; Milton, Richard; Muthukumar, Dakshinamoorthy; Pope, Tony; Roy, Amy; Shah, Riyaz; Shamash, Jonathan; Tasigiannopoulos, Zacharias; Taylor, Paul; Treece, Sarah; Ashton, Kate; Harris, Rosie; Joyce, Katherine; Warnes, Barbara; Mills, Nicola; Stokes, Elizabeth A; Rogers, Chris;
• Other Names: author non-byline.; Gravani Athanasia author non-byline.; McKeon Holly author non-byline.; Underwood Wendy author non-byline.; Brophy Rachel author non-byline.; Farrar Nicola author non-byline.; Hughes Victoria author non-byline.; Elliott Jane author non-byline.; Matthews Claire author non-byline.; Noyes Philip author non-byline.; Nakas Apostolos author non-byline.; Nelson Louise author non-byline.; Tenconi Sara author non-byline.; Socci Laura author non-byline.; Wood Hilary author non-byline.; Hanratty Helena author non-byline.; Stanley Helena author non-byline.; Moore Judith author non-byline.; Rintoul Robert author non-byline.; Miller Suzanne author non-byline.; Gladwell Amy author non-byline.; Castedo Jenny author non-byline.; Stone Amanda author non-byline.; Ingle Charlotte author non-byline.; Hewer Hayley author non-byline.; Li Louise author non-byline.; Aynsley Eleanor author non-byline.; Watson Andrea author non-byline.; Jacobs Charlotte author non-byline.; Hassall Alison author non-byline.; Begum Masuma author non-byline.; Worth Christopher author non-byline.; Piggott Ellie author non-byline.; Nadin Elizabeth author non-byline.; Ashford-Turner Victoria author non-byline.; Callister Matthew author non-byline.; Summers Yvonne author non-byline.; Califano Raffaele author non-byline.; Cove-Smith Laura author non-byline.; Evison Matt author non-byline.; Blinston Maria author non-byline.; Waplington Sara author non-byline.; Ismail Amal author non-byline.; Chant Rachel author non-byline.; Desai Asmita author non-byline.; Novasio Juliette author non-byline.; Kirwan Marie author non-byline.; Morgan Ian author non-byline.; Lake Victoria author non-byline.; Harris Nichola author non-byline.; Hodge Simon author non-byline.; Yousaf Nadia author non-byline.; Tokaca Nadza author non-byline.; Januszewski Adam author non-byline.; Athauda Avani author non-byline.; Ramessur Anisha author non-byline.; Grist Emily author non-byline.; Colman Niamh author non-byline.; Flynn Michael author non-byline.; Joyce Joan author non-byline.; Vaughan Sarah author non-byline.; Piga Maria author non-byline.; Sahin Derya author non-byline.; Yongue Agnieszka author non-byline.; Turay Emma author non-byline.; O'Brien Mary author non-byline.; Bhosle Jaishree author non-byline.; Kumar Rajiv author non-byline.; Milner-Watts Charlotte author non-byline.; Brown Jessica author non-byline.; Walder David author non-byline.; Georgiou Alexandros author non-byline.; Wu Xiaorong author non-byline.; Kaudeer Naila author non-byline.; Joshi Kroopa author non-byline.; Davidson Michael author non-byline.; Khakoo Shelize author non-byline.; Ayite Bee author non-byline.; Priest Kathryn author non-byline.; Dobbyn James author non-byline.; Prathapan Vasanthi author non-byline.; McCrimmon Deborah author non-byline.; Ash Natalie author non-byline.; Norton Alison author non-byline.; Peet Bianca author non-byline.; Hennessy Libby author non-byline.; Johnson Rosemary author non-byline.; White Laura author non-byline.;
• Is Part Of: BMJ open. Volume 10:Issue 9(2020)
• Publication Date: 2020-09-01
• Subjects: oncology -- chemotherapy -- thoracic surgery -- thoracic medicine; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-038892
• Languages: English
• ISSNs: 2044-6055

Abstract

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 .