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Mesothelioma and Radical Surgery 2 (MARS2)

Primary Purpose

Mesothelioma

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
(Extended) pleurectomy decortication
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesothelioma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barts Health NHS TrustRecruiting
  • The Queen Elizabeth Hospital BirminghamRecruiting
  • North Bristol TrustRecruiting
  • PapworthRecruiting
  • ColchesterRecruiting
  • DerbyRecruiting
  • Beatson West of Scotland Cancer CentreRecruiting
  • Golden Jubilee National Hospital
  • LeedsRecruiting
  • University Hospitals of Leicester NHS TrustRecruiting
  • Barts Health NHS TrustRecruiting
  • Guy's and St Thomas' NHS Foundation TrustRecruiting
  • Royal MarsdenRecruiting
  • Maidstone and Tunbridge Wells NHS TrustRecruiting
  • WythenshaweRecruiting
  • South TeesRecruiting
  • South Tyneside NHS Foundation TrustRecruiting
  • Royal GwentRecruiting
  • Norfolk and Norwich University HospitalRecruiting
  • Oxford University HospitalsRecruiting
  • North West Anglia NHS Foundation TrustRecruiting
  • University Hospitals PlymouthRecruiting
  • Sheffield Teaching Hospitals NHS Foundation TrustRecruiting
  • ClatterbridgeRecruiting
  • New CrossRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgery

no surgery

Arm Description

(Extended) pleurectomy decortication

no surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression free survival to two years
Serious adverse health events to two years after randomisation
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.
Resource and health service use to two years and during initial surgical admission for surgical arm
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
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

Full Information

First Posted
December 20, 2013
Last Updated
October 28, 2019
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
University of Bristol, National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT02040272
Brief Title
Mesothelioma and Radical Surgery 2
Acronym
MARS2
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).
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
University of Bristol, National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
328 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Experimental
Arm Description
(Extended) pleurectomy decortication
Arm Title
no surgery
Arm Type
No Intervention
Arm Description
no surgery
Intervention Type
Procedure
Intervention Name(s)
(Extended) pleurectomy decortication
Primary Outcome Measure Information:
Title
Survival
Description
The time from randomisation to death will be measured and date of death will be collected on purposely designed case report forms.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Progression free survival to two years
Time Frame
24 months
Title
Serious adverse health events to two years after randomisation
Time Frame
24 months
Title
Health Related Quality of Life: EORTC QLQ-C30 (questionnaire) to two years
Description
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.
Time Frame
24 months
Title
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
Title
Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years
Description
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
Time Frame
24 Months
Title
Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years
Description
VAS (visual analogue scale) score. Ranges from 0 to 100. A higher score indicates better quality of life
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Lim
Email
e.lim@rbht.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Study Mailbox
Email
Mars2-trial@bristol.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Lim
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barts Health NHS Trust
City
London
State/Province
Whitechapel
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Lau
First Name & Middle Initial & Last Name & Degree
Kelvin Lau
Facility Name
The Queen Elizabeth Hospital Birmingham
City
Birmingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Middleton, PhD
First Name & Middle Initial & Last Name & Degree
Gary Middleton, PhD
Facility Name
North Bristol Trust
City
Bristol
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick Maskell
First Name & Middle Initial & Last Name & Degree
Nick Maskell
Facility Name
Papworth
City
Cambridge
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Rintoul
First Name & Middle Initial & Last Name & Degree
Robert Rintoul
Facility Name
Colchester
City
Colchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dakshinamoorthy Muthukumar
First Name & Middle Initial & Last Name & Degree
Dakshinamoorthy Muthukumar
Facility Name
Derby
City
Derby
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manjusha Keni
First Name & Middle Initial & Last Name & Degree
Manjusha Keni
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinton Ali
First Name & Middle Initial & Last Name & Degree
Clinton Ali
Facility Name
Golden Jubilee National Hospital
City
Glasgow
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Kirk
First Name & Middle Initial & Last Name & Degree
Alan Kirk
Facility Name
Leeds
City
Leeds
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Milton
First Name & Middle Initial & Last Name & Degree
Richard Milton
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dean Fennell
First Name & Middle Initial & Last Name & Degree
Dean Fennell
Facility Name
Barts Health NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Lau
First Name & Middle Initial & Last Name & Degree
Kevin Lau
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Bille, PhD
First Name & Middle Initial & Last Name & Degree
Andrea Bille, PhD
Facility Name
Royal Marsden
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjay Popat
First Name & Middle Initial & Last Name & Degree
Sanjay Popat
Facility Name
Maidstone and Tunbridge Wells NHS Trust
City
Maidstone
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riyaz Shah, PhD
First Name & Middle Initial & Last Name & Degree
Riyaz Shah, PhD
Facility Name
Wythenshawe
City
Manchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Taylor
First Name & Middle Initial & Last Name & Degree
Paul Taylor
Facility Name
South Tees
City
Middlesbrough
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Talal Mansy
First Name & Middle Initial & Last Name & Degree
Talal Mansy
Facility Name
South Tyneside NHS Foundation Trust
City
Newcastle upon Tyne
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liz Fuller
First Name & Middle Initial & Last Name & Degree
Liz Fuller
Facility Name
Royal Gwent
City
Newport
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina Ionescu
First Name & Middle Initial & Last Name & Degree
Alina Ionescu
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zacharias Tasigiannopoulos
First Name & Middle Initial & Last Name & Degree
Zacharias Tasigiannopoulos
Facility Name
Oxford University Hospitals
City
Oxford
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Najib M Rahman, Prof
First Name & Middle Initial & Last Name & Degree
Najib M Rahman, Prof
Facility Name
North West Anglia NHS Foundation Trust
City
Peterborough
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Treece
Email
hollyemilymckeon4@gmail.co
First Name & Middle Initial & Last Name & Degree
Sarah Treece
Facility Name
University Hospitals Plymouth
City
Plymouth
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Roy, PhD
First Name & Middle Initial & Last Name & Degree
Amy Roy, Phd
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Edwards
First Name & Middle Initial & Last Name & Degree
John Edwards
Facility Name
Clatterbridge
City
Wirral
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Pope
First Name & Middle Initial & Last Name & Degree
Anthony Pope
Facility Name
New Cross
City
Wolverhampton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Morgan
First Name & Middle Initial & Last Name & Degree
Ian Morgan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32873681
Citation
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.
Results Reference
derived
PubMed Identifier
31627746
Citation
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.
Results Reference
derived

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Mesothelioma and Radical Surgery 2

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