Mesothelioma Cancer Mesothelioma
Conditions
Interventions
Prior to randomisation all patients undergo 3 cycles of cisplatin based chemotherapy.
Randomisation arms are with or without extrapleural pneumonectomy (EPP) surgical intervention. Those with EPP will
Sponsors
Guy's and St. Thomas' Hospitals NHS Foundation Trust (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed