Mesothelioma and Radical Surgery 2

  • STATUS
    Recruiting
  • days left to enroll
    86
  • participants needed
    328
  • sponsor
    Royal Brompton & Harefield NHS Foundation Trust
Updated on 23 January 2021
cancer
chemotherapy regimen
asbestos exposure
pleurectomy

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.

Details
Condition Mesothelioma, Mesothelioma, Malignant Mesothelioma
Treatment (Extended) pleurectomy decortication
Clinical Study IdentifierNCT02040272
SponsorRoyal Brompton & Harefield NHS Foundation Trust
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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