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Mesothelioma and Radical Surgery 2

NCT02040272 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2019-10-30

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

(Extended) pleurectomy decortication

Sponsors & Collaborators

  • University of Bristol

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Eric Lim · Royal Brompton & Harefield NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2020-09-30
Completion
2022-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02040272 on ClinicalTrials.gov