1. 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
- Author
-
Liz Darlison, Apostolos Nakas, Wendy Underwood, Matthew Callister, David Waller, Richard Milton, Victoria Ashford-Turner, Paul Taylor, Claire Matthews, Victoria Hughes, Kelvin Lau, Alan Kirk, Robert C Rintoul, Elizabeth A Stokes, Kate Ashton, Daisy Elliott, Rosie Harris, Marie Kirwan, Juliette Novasio, Sara Waplington, Eric Lim, Holly Mckeon, Charlotte Jacobs, Laura White, Mary O’Brien, Judith Moore, Louise Li, Nicola Mills, Sanjay Popat, Suzanne Miller, Nadia Yousaf, D A Fennell, Clinton Ali, Andrea Bille, Liz Fuller, Andreea Ionescu, Manjusha Keni, Pek Koh, Talal Mansy, Dakshinamoorthy Muthukumar, Tony Pope, Amy Roy, Riyaz Shah, Jonathan Shamash, Zacharias Tasigiannopoulos, Sarah Treece, Katherine Joyce, Barbara Warnes, Athanasia Gravani, Rachel Brophy, Nicola Farrar, Jane Elliott, Philip Noyes, Louise Nelson, Sara Tenconi, Laura Socci, Hilary Wood, Helena Hanratty, Helena Stanley, Robert Rintoul, Amy Gladwell, Jenny Castedo, Amanda Stone, Charlotte Ingle, Hayley Hewer, Eleanor Aynsley, Andrea Watson, Alison Hassall, Masuma Begum, Christopher Worth, Ellie Piggott, Elizabeth Nadin, Yvonne Summers, Raffaele Califano, Laura Cove-Smith, Matt Evison, Maria Blinston, Amal Ismail, Rachel Chant, Asmita Desai, Ian Morgan, Victoria Lake, Nichola Harris, Simon Hodge, Nadza Tokaca, Adam Januszewski, Avani Athauda, Anisha Ramessur, Emily Grist, Niamh Colman, Michael Flynn, Joan Joyce, Sarah Vaughan, Maria Piga, Derya Sahin, Agnieszka Yongue, Emma Turay, Jaishree Bhosle, Rajiv Kumar, Charlotte Milner-Watts, Jessica Brown, David Walder, Alexandros Georgiou, Xiaorong Wu, Naila Kaudeer, Kroopa Joshi, Michael Davidson, Shelize Khakoo, Bee Ayite, Kathryn Priest, James Dobbyn, Vasanthi Prathapan, Deborah McCrimmon, Natalie Ash, Alison Norton, Bianca Peet, Libby Hennessy, Rosemary Johnson, Warnes, Barbara [0000-0002-1326-0448], Stokes, Elizabeth A [0000-0002-4179-1369], and Apollo - University of Cambridge Repository
- Subjects
Mesothelioma ,medicine.medical_specialty ,Lung Neoplasms ,Pleural Neoplasms ,thoracic medicine ,medicine.medical_treatment ,chemotherapy ,1117 Public Health and Health Services ,law.invention ,Pneumonectomy ,Randomized controlled trial ,law ,London ,medicine ,Humans ,Multicenter Studies as Topic ,Radical surgery ,Adverse effect ,Randomized Controlled Trials as Topic ,business.industry ,General surgery ,Mesothelioma, Malignant ,1103 Clinical Sciences ,General Medicine ,medicine.disease ,thoracic surgery ,Treatment Outcome ,Pemetrexed ,Oncology ,Cardiothoracic surgery ,Quality of Life ,Medicine ,business ,Pleurectomy ,MARS 2 Trialists ,1199 Other Medical and Health Sciences ,medicine.drug - Abstract
IntroductionMesothelioma 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 analysisThe 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 disseminationResearch 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 numbersISRCTN—ISRCTN44351742 and ClinicalTrials.gov—NCT02040272.
- Published
- 2020
- Full Text
- View/download PDF