Mesothelioma and Radical Surgery 2 (MARS2)

October 28, 2019 updated by: Royal Brompton & Harefield NHS Foundation Trust

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

328

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom
        • Recruiting
        • The Queen Elizabeth Hospital Birmingham
        • Contact:
          • Gary Middleton, PhD
        • Principal Investigator:
          • Gary Middleton, PhD
      • Bristol, United Kingdom
        • Recruiting
        • North Bristol Trust
        • Contact:
          • Nick Maskell
        • Principal Investigator:
          • Nick Maskell
      • Cambridge, United Kingdom
        • Recruiting
        • Papworth
        • Contact:
          • Robert Rintoul
      • Colchester, United Kingdom
        • Recruiting
        • Colchester
        • Principal Investigator:
          • Dakshinamoorthy Muthukumar
        • Contact:
          • Dakshinamoorthy Muthukumar
      • Derby, United Kingdom
        • Recruiting
        • Derby
        • Principal Investigator:
          • Manjusha Keni
        • Contact:
          • Manjusha Keni
      • Glasgow, United Kingdom
        • Recruiting
        • Beatson West of Scotland Cancer Centre
        • Contact:
          • Clinton Ali
        • Principal Investigator:
          • Clinton Ali
      • Glasgow, United Kingdom
        • Not yet recruiting
        • Golden Jubilee National Hospital
        • Contact:
          • Alan Kirk
        • Principal Investigator:
          • Alan Kirk
      • Leeds, United Kingdom
        • Recruiting
        • Leeds
        • Contact:
          • Richard Milton
        • Principal Investigator:
          • Richard Milton
      • Leicester, United Kingdom
        • Recruiting
        • University Hospitals of Leicester NHS Trust
        • Contact:
          • Dean Fennell
      • London, United Kingdom
        • Recruiting
        • Barts Health NHS Trust
        • Contact:
          • Kevin Lau
        • Principal Investigator:
          • Kevin Lau
      • London, United Kingdom
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust
        • Contact:
          • Andrea Bille, PhD
        • Principal Investigator:
          • Andrea Bille, PhD
      • London, United Kingdom
        • Recruiting
        • Royal Marsden
        • Contact:
          • Sanjay Popat
        • Principal Investigator:
          • Sanjay Popat
      • Maidstone, United Kingdom
        • Recruiting
        • Maidstone and Tunbridge Wells NHS Trust
        • Contact:
          • Riyaz Shah, PhD
        • Principal Investigator:
          • Riyaz Shah, PhD
      • Manchester, United Kingdom
        • Recruiting
        • Wythenshawe
        • Contact:
          • Paul Taylor
        • Principal Investigator:
          • Paul Taylor
      • Middlesbrough, United Kingdom
        • Recruiting
        • South Tees
        • Contact:
          • Talal Mansy
        • Principal Investigator:
          • Talal Mansy
      • Newcastle upon Tyne, United Kingdom
        • Recruiting
        • South Tyneside NHS Foundation Trust
        • Contact:
          • Liz Fuller
        • Principal Investigator:
          • Liz Fuller
      • Newport, United Kingdom
        • Recruiting
        • Royal Gwent
        • Contact:
          • Alina Ionescu
        • Principal Investigator:
          • Alina Ionescu
      • Norwich, United Kingdom
        • Recruiting
        • Norfolk and Norwich University Hospital
        • Contact:
          • Zacharias Tasigiannopoulos
        • Principal Investigator:
          • Zacharias Tasigiannopoulos
      • Oxford, United Kingdom
        • Recruiting
        • Oxford University Hospitals
        • Contact:
          • Najib M Rahman, Prof
        • Principal Investigator:
          • Najib M Rahman, Prof
      • Peterborough, United Kingdom
        • Recruiting
        • North West Anglia NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Sarah Treece
      • Plymouth, United Kingdom
        • Recruiting
        • University Hospitals Plymouth
        • Contact:
          • Amy Roy, PhD
        • Principal Investigator:
          • Amy Roy, Phd
      • Sheffield, United Kingdom
        • Recruiting
        • Sheffield Teaching Hospitals NHS Foundation Trust
        • Contact:
          • John Edwards
        • Principal Investigator:
          • John Edwards
      • Wirral, United Kingdom
        • Recruiting
        • Clatterbridge
        • Contact:
          • Anthony Pope
        • Principal Investigator:
          • Anthony Pope
      • Wolverhampton, United Kingdom
        • Recruiting
        • New Cross
        • Contact:
          • Ian Morgan
        • Principal Investigator:
          • Ian Morgan
    • Whitechapel
      • London, Whitechapel, United Kingdom
        • Recruiting
        • Barts Health NHS Trust
        • Contact:
          • Kevin Lau
        • Principal Investigator:
          • Kelvin Lau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. 16 years of age or over
  2. Tissue (cytology or histology) confirmed epithelioid, sarcomatoid or biphasic mesothelioma
  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 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 forced expiratory volume after one second (FEV1) or transfer factor of the lung for carbon monoxide (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 is performed 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 improve survival

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgery
(Extended) pleurectomy decortication
Procedure: (Extended) pleurectomy decortication
No Intervention: no surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival to two years
Time Frame: 24 months
24 months
Serious adverse health events to two years after randomisation
Time Frame: 24 months
24 months
Health Related Quality of Life: EORTC QLQ-C30 (questionnaire) to two years
Time Frame: 24 months
  • 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.
24 months
Resource and health service use to two years and during initial surgical admission for surgical arm
Time Frame: 24 months 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
Time Frame: 24 Months
  • 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
24 Months
Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years
Time Frame: 24 months
  • VAS (visual analogue scale) score. Ranges from 0 to 100.
  • A higher score indicates better quality of life
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Collaborators

University of Bristol
National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: Eric Lim, Royal Brompton & Harefield NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

January 16, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 28, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MARS2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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