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Mesothelioma and Radical Surgery 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.

Tracking Information
First Received DateDecember 20, 2013
Last Changed DateOctober 8, 2018
Start DateMay 2015
Anticipated Primary Completion DateSeptember 2020
Primary Outcome Measures

Survival [Time Frame: 24 months]

Secondary Outcome Measures

Progression free survival to two years [Time Frame: 24 months]

Serious adverse health events to two years after randomisation [Time Frame: 24 months]

Health Related Quality of Life: EORTC QLQ-C30 (questionnaire) to two years [Time Frame: 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]

Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years [Time Frame: 24 Months]

Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years [Time Frame: 24 months]

Descriptive Information
PhaseN/A
Study TypeInterventional
Condition
  • Mesothelioma
Intervention
  • Procedure: (Extended) pleurectomy decortication
Study Arms / Comparison Groups2 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment328
GenderAll
Ages16 Years - N/A
Accepts Healthy VolunteersNo
Contact Eric Lim
Email: e.lim@rbht.nhs.uk
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. Ability to provide written informed consent to participate in the trial

Exclusion criteria:

1. Severe shortness of breath (Eastern Cooperative Oncology Group (ECOG) status ≥ 2, 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 (EF less than 30% by echocardiogram)

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. Co-enrolment in another interventional clinical trial

Administrative Information
NCTIDNCT02040272
Responsible PartySponsor
SponsorRoyal Brompton & Harefield NHS Foundation Trust
Verification DateOctober 2018
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