Journal article
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
- Abstract:
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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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, 793.4KB, Terms of use)
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- Publisher copy:
- 10.1136/bmjopen-2020-038892
Authors
- Publisher:
- BMJ Publishing Group
- Journal:
- BMJ Open More from this journal
- Volume:
- 10
- Issue:
- 9
- Article number:
- e038892
- Publication date:
- 2020-09-01
- Acceptance date:
- 2020-06-24
- DOI:
- EISSN:
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2044-6055
- Pmid:
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32873681
- Language:
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English
- Keywords:
- Pubs id:
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1130591
- Local pid:
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pubs:1130591
- Deposit date:
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2020-09-23
Terms of use
- Copyright holder:
- Lim et al.
- Copyright date:
- 2020
- Rights statement:
- ©2020 Author(s) (or their employer(s)). Re-use permitted under CC BY. Published by BMJ.
- Notes:
- This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
- Licence:
- CC Attribution (CC BY)
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