Mesothelioma And Radical Surgery

Guy's and St. Thomas' Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 100 人开始时间: 2004年7月5日最近更新: 2018年11月12日

适应症

试验速览

•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%

发起方

Guy's and St. Thomas' Hospitals NHS Foundation Trust (UK)