Brief Title
Mesothelioma and Radical Surgery 2
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).
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.
Study Type
Interventional
Primary Outcome
Survival
Secondary Outcome
Progression free survival to two years
Condition
Mesothelioma
Intervention
(Extended) pleurectomy decortication
Study Arms / Comparison Groups
Surgery
Description: (Extended) pleurectomy decortication
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
328
Start Date
May 2015
Completion Date
September 2022
Primary Completion Date
September 2020
Eligibility Criteria
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
Gender
All
Ages
16 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Eric Lim, , [email protected]
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT02040272
Organization ID
MARS2
Responsible Party
Sponsor
Study Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
University of Bristol
Study Sponsor
Eric Lim, Principal Investigator, Royal Brompton & Harefield NHS Foundation Trust
Verification Date
October 2019