Mesothelioma and Radical Surgery 2
- Conditions
- Mesothelioma
- Interventions
- Procedure: (Extended) pleurectomy decortication
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 328
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgery (Extended) pleurectomy decortication (Extended) pleurectomy decortication
- 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 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 lifeProgression free survival to two years 24 months
Trial Locations
- Locations (24)
Barts Health NHS Trust
š¬š§London, United Kingdom
The Queen Elizabeth Hospital Birmingham
š¬š§Birmingham, United Kingdom
North Bristol Trust
š¬š§Bristol, United Kingdom
Papworth
š¬š§Cambridge, United Kingdom
Beatson West of Scotland Cancer Centre
š¬š§Glasgow, United Kingdom
Colchester
š¬š§Colchester, United Kingdom
Derby
š¬š§Derby, United Kingdom
Golden Jubilee National Hospital
š¬š§Glasgow, United Kingdom
University Hospitals of Leicester NHS Trust
š¬š§Leicester, United Kingdom
Royal Marsden
š¬š§London, United Kingdom
Maidstone and Tunbridge Wells NHS Trust
š¬š§Maidstone, United Kingdom
Wythenshawe
š¬š§Manchester, United Kingdom
South Tees
š¬š§Middlesbrough, United Kingdom
South Tyneside NHS Foundation Trust
š¬š§Newcastle upon Tyne, United Kingdom
Royal Gwent
š¬š§Newport, United Kingdom
Norfolk and Norwich University Hospital
š¬š§Norwich, United Kingdom
Oxford University Hospitals
š¬š§Oxford, United Kingdom
Clatterbridge
š¬š§Wirral, United Kingdom
North West Anglia NHS Foundation Trust
š¬š§Peterborough, United Kingdom
University Hospitals Plymouth
š¬š§Plymouth, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
š¬š§Sheffield, United Kingdom
New Cross
š¬š§Wolverhampton, United Kingdom
Leeds
š¬š§Leeds, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
š¬š§London, United Kingdom