Surgical and large bore pleural interventions in malignant pleural mesothelioma and radiotherapy trial (The SMART Trial)

Introduction: Malignant pleural mesothelioma is universally fatal tumour, the incidence of which continues to rise. 'Procedure tract metastasis' (PTM) may develop at the site of previous pleural interventions and prophylactic radiotherapy has previously been used to minimise this complication. However, three small trials already conducted in this area showed conflicting results with regards to its efficacy. This has led to significant variation in practice around the UK and confusion regarding the optimal treatment strategy for these patients. The SMART trial is a suitably powered, multi-centre study, designed to conclusively answer this much debated research question. Methods: 203 patents with a histo-cytologically proven diagnosis of malignant pleural mesothelioma, who have undergone a large bore pleural intervention (thoracic surgical procedure, large bore chest drain, indwelling pleural catheter or local anaesthetic thoracoscopy) in the previous 35 days will be recruited to the study. Written informed consent will be taken. Patients will be randomised to either receive immediate radiotherapy (21 Gy in 3#s within 42 days of the pleural intervention) or deferred radiotherapy (21 Gy in 3#s given in the event of a PTM developing). Patients will be followed up for 12 months. Data regarding the incidence of PTM, quality of life data and chest pain scores will be collected. Results: 23 UK centres are currently open to recruitment and since the trial opened in December 2011, 60 patients have been recruited to the study. Conclusion: This randomised controlled clinical trial is currently recruiting in centres around the UK and 30% of the required patients have already been enrolled. We hope recruitment will be complete by the end of 2013. This will allow publication of the results in early 2015 when all patients have completed 12 months follow up.