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; Liz Darlison; John Edwards; Daisy Elliott; D. A. Fennell; Sanjay Popat; Robert C. Rintoul; David Waller; Clinton Ali; Andrea Bille; Liz Fuller; Andreea Ionescu; Manjusha Keni; Alan Kirk; Pek Koh; Kelvin Lau; Talal Mansy; Nick A. Maskell; Richard Milton; Dakshinamoorthy Muthukumar; Tony Pope; Amy Roy; Riyaz Shah; Jonathan Shamash; Zacharias Tasigiannopoulos; Paul Taylor; Sarah Treece; Kate Ashton; Rosie Harris; Katherine Joyce; Barbara Warnes; Nicola Mills; Elizabeth A. Stokes; Chris Rogers; MARS 2 Trialists

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, Liz Darlison, John Edwards, Daisy Elliott, D. A. Fennell, Sanjay Popat, Robert C. Rintoul, David Waller, Clinton Ali, Andrea Bille, Liz Fuller, Andreea Ionescu, Manjusha Keni, Alan Kirk, Pek Koh, Kelvin Lau, Talal Mansy, Nick A. Maskell, Richard Milton, Dakshinamoorthy MuthukumarTony Pope, Amy Roy, Riyaz Shah, Jonathan Shamash, Zacharias Tasigiannopoulos, Paul Taylor, Sarah Treece, Kate Ashton, Rosie Harris, Katherine Joyce, Barbara Warnes, Nicola Mills, Elizabeth A. Stokes, Chris Rogers, MARS 2 Trialists

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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.

Original language	English
Article number	e038892
Journal	BMJ Open
Volume	10
Issue number	9
DOIs	https://doi.org/10.1136/bmjopen-2020-038892
Publication status	Published - 1 Sep 2020

Keywords

chemotherapy
oncology
thoracic medicine
thoracic surgery

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Published_VersionFinal published version, 793 KBLicence: CC BY

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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., ... MARS 2 Trialists (2020). 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, 10(9), [e038892]. https://doi.org/10.1136/bmjopen-2020-038892

@article{68ac714389514d7db096e054e0b824ee,

title = "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 = "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",

author = "Eric Lim and Liz Darlison and John Edwards and Daisy Elliott and Fennell, {D. A.} and Sanjay Popat and Rintoul, {Robert C.} and David Waller and Clinton Ali and Andrea Bille and Liz Fuller and Andreea Ionescu and Manjusha Keni and Alan Kirk and Pek Koh and Kelvin Lau and Talal Mansy and Maskell, {Nick A.} and Richard Milton and Dakshinamoorthy Muthukumar and Tony Pope and Amy Roy and Riyaz Shah and Jonathan Shamash and Zacharias Tasigiannopoulos and Paul Taylor and Sarah Treece and Kate Ashton and Rosie Harris and Katherine Joyce and Barbara Warnes and Nicola Mills and Stokes, {Elizabeth A.} and Chris Rogers and {MARS 2 Trialists} and Eleanor Mishra",

year = "2020",

month = sep,

day = "1",

doi = "10.1136/bmjopen-2020-038892",

language = "English",

volume = "10",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "9",

}

Lim, E, Darlison, L, Edwards, J, Elliott, D, Fennell, DA, Popat, S, Rintoul, RC, Waller, D, Ali, C, Bille, A, Fuller, L, Ionescu, A, Keni, M, Kirk, A, Koh, P, Lau, K, Mansy, T, Maskell, NA, Milton, R, Muthukumar, D, Pope, T, Roy, A, Shah, R, Shamash, J, Tasigiannopoulos, Z, Taylor, P, Treece, S, Ashton, K, Harris, R, Joyce, K, Warnes, B, Mills, N, Stokes, EA, Rogers, C & MARS 2 Trialists 2020, '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, vol. 10, no. 9, e038892. https://doi.org/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. / Lim, Eric; Darlison, Liz; Edwards, John et al.

In: BMJ Open, Vol. 10, No. 9, e038892, 01.09.2020.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

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

AU - Lim, Eric

AU - Darlison, Liz

AU - Edwards, John

AU - Elliott, Daisy

AU - Fennell, D. A.

AU - Popat, Sanjay

AU - Rintoul, Robert C.

AU - Waller, David

AU - Ali, Clinton

AU - Bille, Andrea

AU - Fuller, Liz

AU - Ionescu, Andreea

AU - Keni, Manjusha

AU - Kirk, Alan

AU - Koh, Pek

AU - Lau, Kelvin

AU - Mansy, Talal

AU - Maskell, Nick A.

AU - Milton, Richard

AU - Muthukumar, Dakshinamoorthy

AU - Pope, Tony

AU - Roy, Amy

AU - Shah, Riyaz

AU - Shamash, Jonathan

AU - Tasigiannopoulos, Zacharias

AU - Taylor, Paul

AU - Treece, Sarah

AU - Ashton, Kate

AU - Harris, Rosie

AU - Joyce, Katherine

AU - Warnes, Barbara

AU - Mills, Nicola

AU - Stokes, Elizabeth A.

AU - Rogers, Chris

AU - MARS 2 Trialists

AU - Mishra, Eleanor

PY - 2020/9/1

Y1 - 2020/9/1

N2 - 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.

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.

KW - chemotherapy

KW - oncology

KW - thoracic medicine

KW - thoracic surgery

UR - http://europepmc.org/abstract/med/32873681

UR - http://www.scopus.com/inward/record.url?scp=85090179882&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2020-038892

DO - 10.1136/bmjopen-2020-038892

M3 - Article

C2 - 32873681

VL - 10

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 9

M1 - e038892

ER -

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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Keywords

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