RT Journal Article
SR Electronic
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
FD British Medical Journal Publishing Group
SP e038892
DO 10.1136/bmjopen-2020-038892
VO 10
IS 9
A1 Lim, Eric
A1 Darlison, Liz
A1 Edwards, John
A1 Elliott, Daisy
A1 Fennell, D A
A1 Popat, Sanjay
A1 Rintoul, Robert C
A1 Waller, David
A1 Ali, Clinton
A1 Bille, Andrea
A1 Fuller, Liz
A1 Ionescu, Andreea
A1 Keni, Manjusha
A1 Kirk, Alan
A1 Koh, Pek
A1 Lau, Kelvin
A1 Mansy, Talal
A1 Maskell, Nick A
A1 Milton, Richard
A1 Muthukumar, Dakshinamoorthy
A1 Pope, Tony
A1 Roy, Amy
A1 Shah, Riyaz
A1 Shamash, Jonathan
A1 Tasigiannopoulos, Zacharias
A1 Taylor, Paul
A1 Treece, Sarah
A1 Ashton, Kate
A1 Harris, Rosie
A1 Joyce, Katherine
A1 Warnes, Barbara
A1 Mills, Nicola
A1 Stokes, Elizabeth A
A1 Rogers, Chris
A1 ,
YR 2020
UL http://bmjopen.bmj.com/content/10/9/e038892.abstract
AB 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.