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.
chemotherapy
oncology
thoracic medicine
thoracic surgery
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
01 09 2020
01 09 2020
Historique:
entrez:
3
9
2020
pubmed:
3
9
2020
medline:
15
5
2021
Statut:
epublish
Résumé
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. 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. 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. ISRCTN-ISRCTN44351742 and ClinicalTrials.gov-NCT02040272.
Identifiants
pubmed: 32873681
pii: bmjopen-2020-038892
doi: 10.1136/bmjopen-2020-038892
pmc: PMC7467531
doi:
Banques de données
ClinicalTrials.gov
['NCT02040272']
ISRCTN
['ISRCTN44351742']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e038892Subventions
Organisme : Department of Health
ID : 15/188/31
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/K025643/1
Pays : United Kingdom
Organisme : Cancer Research UK
Pays : United Kingdom
Investigateurs
Athanasia Gravani
(A)
Holly McKeon
(H)
Wendy Underwood
(W)
Rachel Brophy
(R)
Nicola Farrar
(N)
Victoria Hughes
(V)
Jane Elliott
(J)
Claire Matthews
(C)
Philip Noyes
(P)
Apostolos Nakas
(A)
Louise Nelson
(L)
Sara Tenconi
(S)
Laura Socci
(L)
Hilary Wood
(H)
Helena Hanratty
(H)
Helena Stanley
(H)
Judith Moore
(J)
Robert Rintoul
(R)
Suzanne Miller
(S)
Amy Gladwell
(A)
Jenny Castedo
(J)
Amanda Stone
(A)
Charlotte Ingle
(C)
Hayley Hewer
(H)
Louise Li
(L)
Eleanor Aynsley
(E)
Andrea Watson
(A)
Charlotte Jacobs
(C)
Alison Hassall
(A)
Masuma Begum
(M)
Christopher Worth
(C)
Ellie Piggott
(E)
Elizabeth Nadin
(E)
Victoria Ashford-Turner
(V)
Matthew Callister
(M)
Yvonne Summers
(Y)
Raffaele Califano
(R)
Laura Cove-Smith
(L)
Matt Evison
(M)
Maria Blinston
(M)
Sara Waplington
(S)
Amal Ismail
(A)
Rachel Chant
(R)
Asmita Desai
(A)
Juliette Novasio
(J)
Marie Kirwan
(M)
Ian Morgan
(I)
Victoria Lake
(V)
Nichola Harris
(N)
Simon Hodge
(S)
Nadia Yousaf
(N)
Nadza Tokaca
(N)
Adam Januszewski
(A)
Avani Athauda
(A)
Anisha Ramessur
(A)
Emily Grist
(E)
Niamh Colman
(N)
Michael Flynn
(M)
Joan Joyce
(J)
Sarah Vaughan
(S)
Maria Piga
(M)
Derya Sahin
(D)
Agnieszka Yongue
(A)
Emma Turay
(E)
Mary O'Brien
(M)
Jaishree Bhosle
(J)
Rajiv Kumar
(R)
Charlotte Milner-Watts
(C)
Jessica Brown
(J)
David Walder
(D)
Alexandros Georgiou
(A)
Xiaorong Wu
(X)
Naila Kaudeer
(N)
Kroopa Joshi
(K)
Michael Davidson
(M)
Shelize Khakoo
(S)
Bee Ayite
(B)
Kathryn Priest
(K)
James Dobbyn
(J)
Vasanthi Prathapan
(V)
Deborah McCrimmon
(D)
Natalie Ash
(N)
Alison Norton
(A)
Bianca Peet
(B)
Libby Hennessy
(L)
Rosemary Johnson
(R)
Laura White
(L)
Edward Armstrong
(E)
Maria Coakley
(M)
Scott Shepherd
(S)
Narda Chaabouni
(N)
Katherina Sreter
(K)
Vasileios Angelis
(V)
Mariko Morishita
(M)
Jose Roca
(J)
Mary Jane de los Reyes Lauigan
(MJ)
Katrin Sainudeen
(K)
Helen Morgan
(H)
Abigail Hollingdale
(A)
Chloe Eddings
(C)
Holly Warman
(H)
Jeremy Steele
(J)
Jo Hargrave
(J)
Resmi Jayachandran
(R)
Pratistha Panday
(P)
Austin McInnes
(A)
Rocco Bilancia
(R)
Julie Buckley
(J)
Elizabeth Boyd
(E)
Natalie Zahan-Evans
(N)
Anna Morley
(A)
Adela Dann
(A)
Eleanor Mishra
(E)
Pinelopi Gkogkou
(P)
Irene Harvey
(I)
Hilary Congdon
(H)
Alison Ray
(A)
Jehan Mansi
(J)
Amy Quinn
(A)
Najib M Rahman
(NM)
Jack Seymour
(J)
Hannah Ball
(H)
Meenali Chitnis
(M)
Eirini Petroyannou
(E)
Kimberley Snoad
(K)
Monica Tavares Barbosa
(M)
Gary Middleton
(G)
Philip Earwaker
(P)
Haider Abbas
(H)
Parminder Sohal
(P)
Marcus Flather
(M)
Paul Beckett
(P)
Carol Tan
(C)
Fergus Gleeson
(F)
Fergus MacBeth
(F)
Mavis Nye
(M)
Harvey Pass
(H)
Pauline Leonard
(P)
Tom Treasure
(T)
Linda Sharples
(L)
Valerie Rusch
(V)
Mark Britton
(M)
Robin Rudd
(R)
Joseph S Friedberg
(JS)
Peter Goldstraw
(P)
Informations de copyright
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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