Mesothelioma And Radical Surgery
- Conditions
- MesotheliomaCancer
- Registration Number
- ISRCTN95583524
- Lead Sponsor
- Guy's and St. Thomas' Hospitals NHS Foundation Trust (UK)
- Brief Summary
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17670513 2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19661833 3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21723781
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Two phase eligibility:
Registration Eligibility criteria at registration:
1. 18 years of age or older
2. Histologically proven mesothelioma
3. Fit to undergo extrapleural pneumonectomy (EPP) as per British Thoracic Society (BTS) guidelines
4. Fit to undergo the planned post-operative radiotherapy
5. Able to complete Quality of Life questionnaires
6. Able to comply with follow-up requirements
7. Written informed consent for registration
8. Positron emission tomography (PET) or mediastinoscopy negative
9. No distant metastases
Once chemotherapy has been completed a further eligibility criteria is checked to determine continued eligibility for randomisation.
Eligibility criteria for randomisation:
1. Still fulfil eligibility criteria for registration
2. Completion of 3 cycles of chemotherapy
3. Operable disease (T1-3, N0-1, M0)
4. Biopsy proven malignant mesothelioma on histology and immuno-histochemistry
5. Normal renal function
6. World Health Organisation (WHO) performance status 0 or 1
7. Written informed consent for randomisation
1. Predicted post-operative forced expiratory volume in 1 second (FEV1) of less than 40% and carbon monoxide transfer factor (TLCO) of less than 40%
2. Significant pulmonary hypertension
3. Cardiac ejection fraction of less than 40%
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ot provided at time of registration
- Secondary Outcome Measures
Name Time Method ot provided at time of registration