BMJ Open (Sep 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
- Liz Darlison,
- Apostolos Nakas,
- Wendy Underwood,
- Matthew Callister,
- David Waller,
- Richard Milton,
- Victoria Ashford-Turner,
- Paul Taylor,
- Claire Matthews,
- Victoria Hughes,
- Kelvin Lau,
- Alan Kirk,
- Robert C Rintoul,
- Elizabeth A Stokes,
- Kate Ashton,
- Daisy Elliott,
- Rosie Harris,
- Marie Kirwan,
- Juliette Novasio,
- Sara Waplington,
- Eric Lim,
- Holly Mckeon,
- Charlotte Jacobs,
- Laura White,
- Mary O’Brien,
- Judith Moore,
- Louise Li,
- Nicola Mills,
- Sanjay Popat,
- Suzanne Miller,
- Nadia Yousaf,
- D A Fennell,
- Clinton Ali,
- Andrea Bille,
- Liz Fuller,
- Andreea Ionescu,
- Manjusha Keni,
- Pek Koh,
- Talal Mansy,
- Dakshinamoorthy Muthukumar,
- Tony Pope,
- Amy Roy,
- Riyaz Shah,
- Jonathan Shamash,
- Zacharias Tasigiannopoulos,
- Sarah Treece,
- Katherine Joyce,
- Barbara Warnes,
- Athanasia Gravani,
- Rachel Brophy,
- Nicola Farrar,
- Jane Elliott,
- Philip Noyes,
- Louise Nelson,
- Sara Tenconi,
- Laura Socci,
- Hilary Wood,
- Helena Hanratty,
- Helena Stanley,
- Robert Rintoul,
- Amy Gladwell,
- Jenny Castedo,
- Amanda Stone,
- Charlotte Ingle,
- Hayley Hewer,
- Eleanor Aynsley,
- Andrea Watson,
- Alison Hassall,
- Masuma Begum,
- Christopher Worth,
- Ellie Piggott,
- Elizabeth Nadin,
- Yvonne Summers,
- Raffaele Califano,
- Laura Cove-Smith,
- Matt Evison,
- Maria Blinston,
- Amal Ismail,
- Rachel Chant,
- Asmita Desai,
- Ian Morgan,
- Victoria Lake,
- Nichola Harris,
- Simon Hodge,
- Nadza Tokaca,
- Adam Januszewski,
- Avani Athauda,
- Anisha Ramessur,
- Emily Grist,
- Niamh Colman,
- Michael Flynn,
- Joan Joyce,
- Sarah Vaughan,
- Maria Piga,
- Derya Sahin,
- Agnieszka Yongue,
- Emma Turay,
- Jaishree Bhosle,
- Rajiv Kumar,
- Charlotte Milner-Watts,
- Jessica Brown,
- David Walder,
- Alexandros Georgiou,
- Xiaorong Wu,
- Naila Kaudeer,
- Kroopa Joshi,
- Michael Davidson,
- Shelize Khakoo,
- Bee Ayite,
- Kathryn Priest,
- James Dobbyn,
- Vasanthi Prathapan,
- Deborah McCrimmon,
- Natalie Ash,
- Alison Norton,
- Bianca Peet,
- Libby Hennessy,
- Rosemary Johnson
Affiliations
- Liz Darlison
- 3 Respiratory, University Hospitals of Leicester, Leicester, UK
- Apostolos Nakas
- Department of Thoracic Surgery, Glenfield Hospital, Leicester, UK
- Wendy Underwood
- 2 Clinical Trials and Evaluation Unit, University of Bristol, Bristol, UK
- Matthew Callister
- 2 St James’ University Hospital, Leeds, UK
- David Waller
- 11 St Bartholomew’s Hospital, London, UK
- Richard Milton
- Thoracic Surgery Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK
- Victoria Ashford-Turner
- 9 Respiratory Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK
- Paul Taylor
- Project ECHO Team, St Luke's Hospice, Sheffield, UK
- Claire Matthews
- 1 Papworth Trials Unit Collaboration, Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK
- Victoria Hughes
- 1 Papworth Trials Unit Collaboration, Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK
- Kelvin Lau
- Department of Thoracic Surgery, Barts Health NHS Trust, London, UK
- Alan Kirk
- Department of Thoracic Surgery, Golden Jubilee National Hospital, Clydebank, UK
- Robert C Rintoul
- Department of Thoracic Oncology, Papworth Hospital NHS Foundation Trust, Cambridge, UK
- Elizabeth A Stokes
- 8 Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK
- Kate Ashton
- Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK
- Daisy Elliott
- 7 Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
- Rosie Harris
- 6 Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK
- Marie Kirwan
- 4 Thoracic Oncology Research Hub, Manchester University NHS Foundation Trust, Manchester, UK
- Juliette Novasio
- 4 Thoracic Oncology Research Hub, Manchester University NHS Foundation Trust, Manchester, UK
- Sara Waplington
- 4 Thoracic Oncology Research Hub, Manchester University NHS Foundation Trust, Manchester, UK
- Eric Lim
- 1 Academic Division of Thoracic Surgery, The Royal Brompton and Harefield NHS foundation Trust, London, UK
- Holly Mckeon
- Bristol Trials Centre, Clinical Trials and Evaluation Unit, Bristol Medical School, University of Bristol, Bristol, UK
- Charlotte Jacobs
- Laura White
- 3 Trauma Audit and Research Network, The University of Manchester, Salford, Manchester, UK
- Mary O’Brien
- 2Edge Hill University, Ormskirk, UK
- Judith Moore
- 1Rennie Grove Hospice Care, St Albans, UK
- Louise Li
- 3 James Cook University Hospital, Middlesbrough, UK
- Nicola Mills
- Population Health Sciences, Bristol Medical School, Bristol, UK
- Sanjay Popat
- Department of Medicine, Royal Marsden NHS Foundation Trust, London, UK
- Suzanne Miller
- 2 Division of Respiratory Medicine, Nottingham Molecular Pathology Node and Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, UK
- Nadia Yousaf
- 1Royal Marsden NHS Foundation Trust, London, UK
- D A Fennell
- Cancer Research UK Centre Leicester, University Hospitals of Leicester NHS Trust, Leicester, UK
- Clinton Ali
- The Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, Glasgow, UK
- Andrea Bille
- Thoracic Surgery, Guy’s and Saint Thomas’ Hospitals NHS Trust, London, UK
- Liz Fuller
- Respiratory Medicine, South Tyneside NHS Foundation Trust, South Shields, UK
- Andreea Ionescu
- Lung Cancer, Aneurin Bevan University Health Board, Newport, UK
- Manjusha Keni
- Oncology, Derby Teaching Hospitals NHS Foundation Trust, Derby, UK
- Pek Koh
- Department of Oncology, New Cross Hospital, Wolverhampton, UK
- Talal Mansy
- Oncology, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK
- Dakshinamoorthy Muthukumar
- Oncology, Colchester Hospital University NHS Foundation Trust, Colchester, UK
- Tony Pope
- Clatterbridge Cancer Centre, Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, UK
- Amy Roy
- Plymouth Oncology Centre, University Hospitals Plymouth NHS Trust, Plymouth, UK
- Riyaz Shah
- Kent Oncology Centre, Maidstone and Tunbridge Wells NHS Trust, Maidstone, UK
- Jonathan Shamash
- Department of Medical Oncology, Barts Health NHS Trust, London, UK
- Zacharias Tasigiannopoulos
- The Oncology Care Team, Norfolk and Norwich University Hospital NHS Trust, Norwich, UK
- Sarah Treece
- Heamatology and Oncology Unit, North West Anglia NHS Foundation Trust, Peterborough, UK
- Katherine Joyce
- Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK
- Barbara Warnes
- Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK
- Athanasia Gravani
- Rachel Brophy
- Nicola Farrar
- Jane Elliott
- Philip Noyes
- Louise Nelson
- Sara Tenconi
- Laura Socci
- Hilary Wood
- Helena Hanratty
- Helena Stanley
- Robert Rintoul
- Amy Gladwell
- Jenny Castedo
- Amanda Stone
- Charlotte Ingle
- Hayley Hewer
- Eleanor Aynsley
- Andrea Watson
- Alison Hassall
- Masuma Begum
- Christopher Worth
- Ellie Piggott
- Elizabeth Nadin
- Yvonne Summers
- Raffaele Califano
- Laura Cove-Smith
- Matt Evison
- Maria Blinston
- Amal Ismail
- Rachel Chant
- Asmita Desai
- Ian Morgan
- Victoria Lake
- Nichola Harris
- Simon Hodge
- Nadza Tokaca
- Adam Januszewski
- FMLM TSG
- Avani Athauda
- Anisha Ramessur
- 3 The Royal Marsden Hospital NHS Foundation Trust, London, UK
- Emily Grist
- Niamh Colman
- Michael Flynn
- Joan Joyce
- Sarah Vaughan
- general practitioner
- Maria Piga
- Derya Sahin
- Agnieszka Yongue
- Emma Turay
- Jaishree Bhosle
- Rajiv Kumar
- Charlotte Milner-Watts
- Jessica Brown
- David Walder
- Alexandros Georgiou
- Xiaorong Wu
- Naila Kaudeer
- Kroopa Joshi
- Michael Davidson
- 3 The Royal Marsden Hospital NHS Foundation Trust, London, UK
- Shelize Khakoo
- Bee Ayite
- Kathryn Priest
- James Dobbyn
- Vasanthi Prathapan
- Deborah McCrimmon
- Natalie Ash
- Alison Norton
- Bianca Peet
- Libby Hennessy
- Rosemary Johnson
- DOI
- https://doi.org/10.1136/bmjopen-2020-038892
- Journal volume & issue
-
Vol. 10,
no. 9
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.
