Clive Amelia O, Wilson Paula, Taylor Hazel, Morley Anna J, de Winton Emma, Panakis Niki, Rahman Najib, Pepperell Justin, Howell Timothy, Batchelor Timothy J P, Jordan Nikki, Lee Y C Gary, Dobson Lee, Maskell Nick A
Respiratory Research Unit, North Bristol NHS Trust, Southmead Hospital, Bristol, UK Academic Respiratory Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
University Hospitals Bristol NHS Trust, Bristol, UK.
BMJ Open. 2015 Jan 9;5(1):e006673. doi: 10.1136/bmjopen-2014-006673.
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 42 days of pleural instrumentation in preventing the development of PTM in MPM.
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 35 days, will be recruited from UK hospitals. Patients will be randomised (1:1) to receive immediate radiotherapy (21 Gy in 3 fractions over 3 working days within 42 days of the pleural intervention) or deferred radiotherapy (21 Gy in 3 fractions over 3 working days given if a PTM develops). Patients will be followed up for 12 months. The primary outcome measure is the rate of PTM until death or 12 months (whichever is sooner), as defined by the presence of a clinically palpable nodule of at least 1 cm diameter felt within 7 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).
The trial has received ethical approval from the Southampton B Research Ethics Committee (11/SC/0408). There is a Trial Steering Committee, including independent members and a patient and public representative. The trial results will be published in a peer-reviewed journal and presented at international conferences.
ISRCTN72767336.
恶性胸膜间皮瘤（MPM）患者可能在既往胸膜干预部位发生疼痛性“手术通道转移”（PTM）。预防性放疗已被用于尽量减少这种并发症；然而，三项小型随机试验关于其有效性的结果相互矛盾。恶性胸膜间皮瘤手术及大口径操作与放疗试验（SMART试验）是一项样本量充足的多中心随机对照试验，旨在评估在胸膜操作后42天内进行预防性放疗对预防MPM患者发生PTM的疗效。
从英国医院招募203例经组织学确诊为MPM且在过去35天内接受过大口径胸膜干预（胸外科手术、大口径胸腔引流管、留置胸膜导管或局部麻醉下胸腔镜检查）的患者。患者将被随机分组（1:1），接受即刻放疗（在胸膜干预后42天内的3个工作日分3次给予21 Gy）或延迟放疗（如果发生PTM，则在3个工作日分3次给予21 Gy）。患者将接受12个月的随访。主要结局指标是至死亡或12个月（以先到者为准）的PTM发生率，定义为经两名评估者确认在手术部位边缘7 cm范围内可触及直径至少1 cm的临床可触及结节。次要结局指标包括胸痛、生活质量、镇痛需求、医疗资源利用和安全性（包括放疗毒性）。
该试验已获得南安普敦B研究伦理委员会的伦理批准（11/SC/0408）。设有试验指导委员会，包括独立成员以及患者和公众代表。试验结果将发表在同行评审期刊上，并在国际会议上公布。
ISRCTN72767336。
