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. 2020 Sep 1;10(9):e038892.
doi: 10.1136/bmjopen-2020-038892.

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

Eric Lim  1 , Liz Darlison  2   3 , John Edwards  4 , Daisy Elliott  5 , D A Fennell  6 , Sanjay Popat  7 , Robert C Rintoul  8 , David Waller  9 , Clinton Ali  10 , Andrea Bille  11 , Liz Fuller  12 , Andreea Ionescu  13 , Manjusha Keni  14 , Alan Kirk  15 , Pek Koh  16 , Kelvin Lau  9 , Talal Mansy  17 , Nick A Maskell  18   19 , Richard Milton  20 , Dakshinamoorthy Muthukumar  21 , Tony Pope  22 , Amy Roy  23 , Riyaz Shah  24 , Jonathan Shamash  25 , Zacharias Tasigiannopoulos  26 , Paul Taylor  27 , Sarah Treece  28 , Kate Ashton  29 , Rosie Harris  29 , Katherine Joyce  29 , Barbara Warnes  29 , Nicola Mills  5 , Elizabeth A Stokes  30 , Chris Rogers  29 ; MARS 2 Trialists
Collaborators, Affiliations

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

Eric Lim et al. BMJ Open. .

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.

Keywords: chemotherapy; oncology; thoracic medicine; thoracic surgery.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Trial schema showing the recruitment pathway for the MARS 2 study.
See this image and copyright information in PMC

References

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