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    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

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    Authors
    Lim, E.
    Darlison, L.
    Edwards, J.
    Elliott, D.
    Fennell, D. A.
    Popat, S.
    Rintoul, R. C.
    Waller, D.
    Ali, C.
    Bille, A.
    Fuller, L.
    Ionescu, A.
    Keni, M.
    Kirk, A.
    Koh, P.
    Lau, K.
    Mansy, T.
    Maskell, N. A.
    Milton, R.
    Muthukumar, D.
    Pope, T.
    Roy, A.
    Shah, R.
    Shamash, J.
    Tasigiannopoulos, Z.
    Taylor, Paul
    Treece, S.
    Ashton, K.
    Harris, R.
    Joyce, K.
    Warnes, B.
    Mills, N.
    Stokes, E. A.
    Rogers, C.
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    Affiliation
    Academic Division of Thoracic Surgery, Royal Brompton and Harefield NHS Trust, London, UK e.lim@rbht.nhs.uk.
    Issue Date
    2020
    
    Metadata
    Show full item record
    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.
    Citation
    Lim E, Darlison L, Edwards J, Elliott D, Fennell DA, Popat S, et al. 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. BMJ Open. 2020;10(9):e038892.
    Journal
    BMJ Open
    URI
    http://hdl.handle.net/10541/623288
    DOI
    10.1136/bmjopen-2020-038892
    PubMed ID
    32873681
    Additional Links
    https://dx.doi.org/10.1136/bmjopen-2020-038892
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1136/bmjopen-2020-038892
    Scopus Count
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