Mesothelioma and Radical Surgery 2

Last updated: October 28, 2019
Sponsor: Royal Brompton & Harefield NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mesothelioma

Treatment

N/A

Clinical Study ID

NCT02040272
MARS2
  • Ages > 16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. 16 years of age or over

  2. Tissue (cytology or histology) confirmed epithelioid, sarcomatoid or biphasicmesothelioma

  3. Disease confined to one hemi-thorax based on CT assessment

  4. Disease deemed surgically resectable

  5. Fit for surgery

  6. Capacity to provide written informed consent to participate in the trial

Exclusion

Exclusion criteria:

  1. 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 forcedexpiratory volume after one second (FEV1) or transfer factor of the lung for carbonmonoxide (TLco) less than 20%)

  2. Serious concomitant disorder that would compromise participant safety during surgery (e.g. evidence of end organ failure)

  3. Severe heart failure (this is defined as NYHA III or IV or if an echocardiogram isperformed an ejection fraction less than 30%)

  4. End stage kidney failure requiring dialysis

  5. Liver failure (e.g. encephalopathy and/or coagulation abnormalities)

  6. Prisoner

  7. Patient lacks capacity to consent

  8. Existing co-enrolment in another interventional clinical trial that aims to improvesurvival

Study Design

Total Participants: 328
Study Start date:
May 01, 2015
Estimated Completion Date:
September 30, 2022

Connect with a study center

  • Barts Health NHS Trust

    London, Whitechapel
    United Kingdom

    Active - Recruiting

  • The Queen Elizabeth Hospital Birmingham

    Birmingham,
    United Kingdom

    Active - Recruiting

  • North Bristol Trust

    Bristol,
    United Kingdom

    Active - Recruiting

  • Burton Hospitals NHS Foundation Trust

    Burton,
    United Kingdom

    Site Not Available

  • Papworth

    Cambridge,
    United Kingdom

    Active - Recruiting

  • Cardiff

    Cardiff,
    United Kingdom

    Site Not Available

  • Colchester

    Colchester,
    United Kingdom

    Active - Recruiting

  • Derby

    Derby,
    United Kingdom

    Active - Recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow,
    United Kingdom

    Active - Recruiting

  • Golden Jubilee National Hospital

    Glasgow,
    United Kingdom

    Site Not Available

  • Leeds

    Leeds,
    United Kingdom

    Active - Recruiting

  • University Hospitals of Leicester NHS Trust

    Leicester,
    United Kingdom

    Active - Recruiting

  • Guy's and St Thomas' NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • Royal Marsden

    London,
    United Kingdom

    Active - Recruiting

  • Maidstone and Tunbridge Wells NHS Trust

    Maidstone,
    United Kingdom

    Active - Recruiting

  • Wythenshawe

    Manchester,
    United Kingdom

    Active - Recruiting

  • South Tees

    Middlesbrough,
    United Kingdom

    Active - Recruiting

  • South Tyneside NHS Foundation Trust

    Newcastle upon Tyne,
    United Kingdom

    Active - Recruiting

  • Royal Gwent

    Newport,
    United Kingdom

    Active - Recruiting

  • Norfolk and Norwich University Hospital

    Norwich,
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals

    Oxford,
    United Kingdom

    Active - Recruiting

  • North West Anglia NHS Foundation Trust

    Peterborough,
    United Kingdom

    Active - Recruiting

  • University Hospitals Plymouth

    Plymouth,
    United Kingdom

    Active - Recruiting

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield,
    United Kingdom

    Active - Recruiting

  • Clatterbridge

    Wirral,
    United Kingdom

    Active - Recruiting

  • New Cross

    Wolverhampton,
    United Kingdom

    Active - Recruiting

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