NCT02040272

Brief Summary

Mesothelioma is a cancer of the thin membrane that lines the chest and abdomen. Around 2500 people in the UK are diagnosed with mesothelioma each year and the median survival is approximately 8.5 months. Exposure to asbestos is the most common cause although the cancer does not usually become apparent until 40-60 years after exposure. Anti-cancer drugs (chemotherapy) are usually given to help treat mesothelioma and sometimes lung-sparing surgery (pleurectomy decortication) is undertaken. However, it is not known if this surgery, in addition to chemotherapy, can increase survival and improve the quality of life for patients. The aim of the MARS2 study is to compare surgery - (extended) pleurectomy decortication - with no surgery with respect to overall survival, cost-effectiveness and quality of life. Patients will be followed up by phone at regular intervals for 2 years. Patients will be asked to complete and return a Quality of Life Questionnaire at these time points. MARS 2 also includes an optional 'Information study', where consenting patients may be interviewed or have their consultations audio-recorded. The aim of the Information study is to explore how a patient makes a decision to take part in research or not, with the overall aim of improving recruitment to clinical trials.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

25 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

5.3 years

First QC Date

December 20, 2013

Last Update Submit

October 28, 2019

Conditions

Mesothelioma

Outcome Measures

Primary Outcomes (1)

  • Survival

    The time from randomisation to death will be measured and date of death will be collected on purposely designed case report forms.

    24 months

Secondary Outcomes (6)

  • Progression free survival to two years

    24 months

  • Serious adverse health events to two years after randomisation

    24 months

  • Health Related Quality of Life: EORTC QLQ-C30 (questionnaire) to two years

    24 months

  • Resource and health service use to two years and during initial surgical admission for surgical arm

    24 months and during initial surgical admission for surgical arm

  • Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years

    24 Months

  • +1 more secondary outcomes

Study Arms (2)

Surgery

EXPERIMENTAL

(Extended) pleurectomy decortication

Procedure: (Extended) pleurectomy decortication

no surgery

NO INTERVENTION

no surgery

Interventions

(Extended) pleurectomy decorticationPROCEDURE
Surgery

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or over
  • Tissue (cytology or histology) confirmed epithelioid, sarcomatoid or biphasic mesothelioma
  • Disease confined to one hemi-thorax based on CT assessment
  • Disease deemed surgically resectable
  • Fit for surgery
  • Capacity to provide written informed consent to participate in the trial

You may not qualify if:

  • Severe shortness of breath (this is defined as an Eastern Cooperative Oncology Group (ECOG) status ≥ 2, or if lung function tests are performed: pre-operative forced expiratory volume after one second (FEV1) or transfer factor of the lung for carbon monoxide (TLco) less than 20%)
  • Serious concomitant disorder that would compromise participant safety during surgery (e.g. evidence of end organ failure)
  • Severe heart failure (this is defined as NYHA III or IV or if an echocardiogram is performed an ejection fraction less than 30%)
  • End stage kidney failure requiring dialysis
  • Liver failure (e.g. encephalopathy and/or coagulation abnormalities)
  • Prisoner
  • Patient lacks capacity to consent
  • Existing co-enrolment in another interventional clinical trial that aims to improve survival

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Barts Health NHS Trust

London, Whitechapel, United Kingdom

RECRUITING

The Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

RECRUITING

North Bristol Trust

Bristol, United Kingdom

RECRUITING

Papworth

Cambridge, United Kingdom

RECRUITING

Colchester

Colchester, United Kingdom

RECRUITING

Derby

Derby, United Kingdom

RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

RECRUITING

Golden Jubilee National Hospital

Glasgow, United Kingdom

NOT YET RECRUITING

Leeds

Leeds, United Kingdom

RECRUITING

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

RECRUITING

Barts Health NHS Trust

London, United Kingdom

RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

RECRUITING

Royal Marsden

London, United Kingdom

RECRUITING

Maidstone and Tunbridge Wells NHS Trust

Maidstone, United Kingdom

RECRUITING

Wythenshawe

Manchester, United Kingdom

RECRUITING

Clatterbridge

Metropolitan Borough of Wirral, United Kingdom

RECRUITING

South Tees

Middlesbrough, United Kingdom

RECRUITING

South Tyneside NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

RECRUITING

Royal Gwent

Newport, United Kingdom

RECRUITING

Norfolk and Norwich University Hospital

Norwich, United Kingdom

RECRUITING

Oxford University Hospitals

Oxford, United Kingdom

RECRUITING

North West Anglia NHS Foundation Trust

Peterborough, United Kingdom

RECRUITING

University Hospitals Plymouth

Plymouth, United Kingdom

RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

RECRUITING

New Cross

Wolverhampton, United Kingdom

RECRUITING

Related Publications (4)

  • Mills N, Farrar N, Warnes B, Ashton KE, Harris R, Rogers CA, Lim E, Elliott D. Strategies to address recruitment to a randomised trial of surgical and non-surgical treatment for cancer: results from a complex recruitment intervention within the Mesothelioma and Radical Surgery 2 (MARS 2) study. BMJ Open. 2024 May 16;14(5):e079108. doi: 10.1136/bmjopen-2023-079108.

    PMID: 38760029DERIVED

  • Lim E, Waller D, Lau K, Steele J, Pope A, Ali C, Bilancia R, Keni M, Popat S, O'Brien M, Tokaca N, Maskell N, Stadon L, Fennell D, Nelson L, Edwards J, Tenconi S, Socci L, Rintoul RC, Wood K, Stone A, Muthukumar D, Ingle C, Taylor P, Cove-Smith L, Califano R, Summers Y, Tasigiannopoulos Z, Bille A, Shah R, Fuller E, Macnair A, Shamash J, Mansy T, Milton R, Koh P, Ionescu AA, Treece S, Roy A, Middleton G, Kirk A, Harris RA, Ashton K, Warnes B, Bridgeman E, Joyce K, Mills N, Elliott D, Farrar N, Stokes E, Hughes V, Nicholson AG, Rogers CA; MARS 2 Investigators. Extended pleurectomy decortication and chemotherapy versus chemotherapy alone for pleural mesothelioma (MARS 2): a phase 3 randomised controlled trial. Lancet Respir Med. 2024 Jun;12(6):457-466. doi: 10.1016/S2213-2600(24)00119-X. Epub 2024 May 10.

    PMID: 38740044DERIVED

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

    PMID: 32873681DERIVED

  • Warnock C, Lord K, Taylor B, Tod A. Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2). Trials. 2019 Oct 18;20(1):598. doi: 10.1186/s13063-019-3692-x.

    PMID: 31627746DERIVED

MeSH Terms

Conditions

Mesothelioma

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Mesothelial

Study Officials

  • Eric Lim

    Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Lim

CONTACT

e.lim@rbht.nhs.uk

Study Mailbox

CONTACT

Mars2-trial@bristol.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2013

First Posted

January 20, 2014

Study Start

May 1, 2015

Primary Completion

September 1, 2020

Study Completion

September 1, 2022

Last Updated

October 30, 2019

Record last verified: 2019-10

Locations

GB(25)