Mesothelioma and Radical Surgery 2

Not Applicable

• Conditions: Mesothelioma

• Registration Number: NCT02040272
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-20
• Study Start: 2015-05
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-30
• Primary Completion: 2020-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 328

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Survival	24 months	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

Name	Time	Method
Progression free survival to two years	24 months
Health Related Quality of Life: EORTC QLQ-C30 (questionnaire) to two years	24 months	* 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.
Serious adverse health events to two years after randomisation	24 months
Resource and health service use to two years and during initial surgical admission for surgical arm	24 months and during initial surgical admission for surgical arm
Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years	24 months	* VAS (visual analogue scale) score. Ranges from 0 to 100.; * A higher score indicates better quality of life

Trial Locations

Locations (24)

Barts Health NHS Trust; 🇬🇧 London, United Kingdom

The Queen Elizabeth Hospital Birmingham; 🇬🇧 Birmingham, United Kingdom

North Bristol Trust; 🇬🇧 Bristol, United Kingdom

Papworth; 🇬🇧 Cambridge, United Kingdom

Colchester; 🇬🇧 Colchester, United Kingdom

Derby; 🇬🇧 Derby, United Kingdom

Beatson West of Scotland Cancer Centre; 🇬🇧 Glasgow, United Kingdom

Golden Jubilee National Hospital; 🇬🇧 Glasgow, United Kingdom

Leeds; 🇬🇧 Leeds, United Kingdom

University Hospitals of Leicester NHS Trust; 🇬🇧 Leicester, United Kingdom

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