BMJ Open 2015 January [Link]
Clive AO, Wilson P, Taylor H, Morley AJ, de Winton E, Panakis N, Rahman N, Pepperell J, Howell T, Batchelor TJ, Jordan N, Lee YC, Dobson L, Maskell NA.
Patients with malignant pleural mesothelioma (MPM) may develop painful ‘procedure tract metastasis’ (PTM) at the site of previous pleural interventions. Prophylactic radiotherapy has been used to minimise this complication; however, three small randomised trials have shown conflicting results regarding its effectiveness. The surgical and large bore procedures in malignant pleural mesothelioma and radiotherapy trial (SMART Trial) is a suitably powered, multicentre, randomised controlled trial, designed to evaluate the efficacy of prophylactic radiotherapy within 42â€…days of pleural instrumentation in preventing the development of PTM in MPM.
Methods and Analysis
203 patients with a histocytologically proven diagnosis of MPM, who have undergone a large bore pleural intervention (thoracic surgery, large bore chest drain, indwelling pleural catheter or local anaesthetic thoracoscopy) in the previous 35â€…days, will be recruited from UK hospitals. Patients will be randomised (1:1) to receive immediate radiotherapy (21â€…Gy in 3 fractions over 3 working days within 42â€…days of the pleural intervention) or deferred radiotherapy (21â€…Gy in 3 fractions over 3 working days given if a PTM develops). Patients will be followed up for 12â€…months. The primary outcome measure is the rate of PTM until death or 12â€…months (whichever is sooner), as defined by the presence of a clinically palpable nodule of at least 1â€…cm diameter felt within 7â€…cm of the margins of the procedure site as confirmed by two assessors. Secondary outcome measures include chest pain, quality of life, analgaesic requirements, healthcare utilisation and safety (including radiotherapy toxicity).