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MesotheliomaMARS2NCT02040272

Mesothelioma and Radical Surgery 2

A study testing (Extended) pleurectomy decortication in people with Mesothelioma, run by Royal Brompton & Harefield NHS Foundation Trust at 25 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Mesothelioma
What is being tested?
(Extended) pleurectomy decortication
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
328 participants
Where
25 sitesUnited Kingdom
Study dates
May 2015to Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 16 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

Who cannot join

  • 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

Trial locations and contacts

25 sites in 1 country.

Eric Lim contact

e.lim@rbht.nhs.uk

Study Mailbox contact

Mars2-trial@bristol.ac.uk

25 sites in 1 country

United Kingdom25 sites, 25 recruiting

  • The Queen Elizabeth Hospital Birmingham

    Birmingham

    Gary Middleton, PhD

    Gary Middleton, PhD

    Recruiting

  • North Bristol Trust

    Bristol

    Nick Maskell

    Nick Maskell

    Recruiting

  • Papworth

    Cambridge

    Robert Rintoul

    Robert Rintoul

    Recruiting

  • Colchester

    Colchester

    Dakshinamoorthy Muthukumar

    Dakshinamoorthy Muthukumar

    Recruiting

  • Derby

    Derby

    Manjusha Keni

    Manjusha Keni

    Recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow

    Clinton Ali

    Clinton Ali

    Recruiting

  • Golden Jubilee National Hospital

    Glasgow

    Alan Kirk

    Alan Kirk

    Not yet recruiting

  • Leeds

    Leeds

    Richard Milton

    Richard Milton

    Recruiting

  • University Hospitals of Leicester NHS Trust

    Leicester

    Dean Fennell

    Dean Fennell

    Recruiting

  • Barts Health NHS Trust

    London, Whitechapel

    Kevin Lau

    Kelvin Lau

    Recruiting

  • Barts Health NHS Trust

    London

    Kevin Lau

    Kevin Lau

    Recruiting

  • Guy's and St Thomas' NHS Foundation Trust

    London

    Andrea Bille, PhD

    Andrea Bille, PhD

    Recruiting

  • Royal Marsden

    London

    Sanjay Popat

    Sanjay Popat

    Recruiting

  • Maidstone and Tunbridge Wells NHS Trust

    Maidstone

    Riyaz Shah, PhD

    Riyaz Shah, PhD

    Recruiting

  • Wythenshawe

    Manchester

    Paul Taylor

    Paul Taylor

    Recruiting

  • Clatterbridge

    Metropolitan Borough of Wirral

    Anthony Pope

    Anthony Pope

    Recruiting

  • South Tees

    Middlesbrough

    Talal Mansy

    Talal Mansy

    Recruiting

  • South Tyneside NHS Foundation Trust

    Newcastle upon Tyne

    Liz Fuller

    Liz Fuller

    Recruiting

  • Royal Gwent

    Newport

    Alina Ionescu

    Alina Ionescu

    Recruiting

  • Norfolk and Norwich University Hospital

    Norwich

    Zacharias Tasigiannopoulos

    Zacharias Tasigiannopoulos

    Recruiting

  • Oxford University Hospitals

    Oxford

    Najib M Rahman, Prof

    Najib M Rahman, Prof

    Recruiting

  • North West Anglia NHS Foundation Trust

    Peterborough

    Sarah Treece, hollyemilymckeon4@gmail.co

    Sarah Treece

    Recruiting

  • University Hospitals Plymouth

    Plymouth

    Amy Roy, PhD

    Amy Roy, Phd

    Recruiting

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield

    John Edwards

    John Edwards

    Recruiting

  • New Cross

    Wolverhampton

    Ian Morgan

    Ian Morgan

    Recruiting

Other trials in United Kingdom

About this study

Official title: Mesothelioma and Radical Surgery 2: a Multicentre Randomised Trial Comparing (Extended) Pleurectomy Decortication Versus no (Extended) Pleurectomy Decortication for Patients With Malignant Pleural Mesothelioma (Mars 2).

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.

Conditions
Mesothelioma
Being tested
(Extended) pleurectomy decortication
Medical subject headings
Mesothelioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • (Extended) pleurectomy decorticationProcedure or surgery

Study groups in NCT02040272
Study groupRoleWhat they receive
SurgeryExperimental(Extended) pleurectomy decortication
Receives: Procedure: (Extended) pleurectomy decortication
no surgeryNo interventionno surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

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

    Measured: 24 months

Secondary outcomes (6)

  1. Progression free survival to two years

    Measured: 24 months

  2. Serious adverse health events to two years after randomisation

    Measured: 24 months

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

    • 3 types of scales. Functioning scales which include physical functioning, role functioning, emotional function, cognitive functioning and social functioning. Symptom scales which include fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties. An overall global health status/QoL
    • All scales range between 0 and 100.
    • For functioning scales, a high score indicates a high level of functioning. Similarly, a high global health status/QoL score indicates a high quality of life. For symptom scales, a high score indicates a high level of symptoms.

    Measured: 24 months

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

    Measured: 24 months and during initial surgical admission for surgical arm

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

    • subscales: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. These range from 1-5.
    • subscales mobility, self-care, usual activities, pain/discomfort, anxiety/depression are combined to calculate an overall index score which ranges from -0.59 to 1.
    • A higher score indicates better quality of life

    Measured: 24 Months

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

    • VAS (visual analogue scale) score. Ranges from 0 to 100.
    • A higher score indicates better quality of life

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2014 (estimated)
  2. Study startMay 2015
  3. Primary completionSep 2020 (estimated)
  4. Study completionSep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
328 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02040272
Sponsor's protocol ID
MARS2
Acronym
MARS2
Status last verified
Oct 2019
First submitted
20 Dec 2013
Last updated
30 Oct 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38760029

  • 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.

    PubMed 38740044

  • 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.

    PubMed 32873681

  • 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.

    PubMed 31627746

Questions about this trial

What is this clinical trial studying?

A study testing (Extended) pleurectomy decortication in people with Mesothelioma, run by Royal Brompton & Harefield NHS Foundation Trust at 25 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eric Lim (e.lim@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02040272, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.

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