Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer (ROCS: Radiotherapy after Oesophageal Cancer Stenting): study protocol for a randomized controlled trial.
Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer (ROCS: Radiotherapy after Oesophageal Cancer Stenting): study protocol for a randomized controlled trial.
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DOI：
10.1186/1745-6215-15-402
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发表时间：
2014-10-22
期刊：
影响因子：
2.5
通讯作者：
Byrne A
中科院分区：
文献类型：
--
作者：
Adamson D;Blazeby J;Nelson A;Hurt C;Nixon L;Fitzgibbon J;Crosby T;Staffurth J;Evans M;Kelly NH;Cohen D;Griffiths G;Byrne A
晚期食管癌患者最令人痛苦的症状是吞咽困难。在缓解吞咽困难的更有效的治疗方法中，插入自膨式金属支架（SEMS）。可能的是，增加姑息剂量的外照射放疗可以延长吞咽困难的缓解，并提供额外的生存获益。ROCS试验将评估食管支架置入后增加姑息性放疗的效果。该研究是一项随机多中心III期试验，具有内部试点阶段，比较了无法治愈的食管癌患者单独支架与支架加姑息性放疗。合格的参与者是需要植入支架以进行吞咽困难初级治疗的晚期食管癌患者。在支架插入后4周内，放射治疗将在1周内分5次给予20戈瑞（戈伊）或在2周内分10次给予30戈伊。内部试点将评估招募率和招募方法;预先商定的标准将决定是否进入主试验。总共将有496例患者以1：1的比例随机分组，随访至死亡。主要结局是患者报告的吞咽困难进展时间。次要结局包括生存率、毒性、卫生资源利用和生活质量。一项嵌入式定性研究将通过检查患者参与的动机及其同意和招募的经历（包括不同意的原因）来探索患者招募的可行性。ROCS研究将是一项具有挑战性的试验，研究预后不良患者的姑息治疗。内部试点设计将优化招募和数据收集方法，以确保按时完成主要试验。作为一项务实的试验，研究优势包括在常规护理场所收集所有随访数据，并关注患者报告的结果，而不是疾病导向的结果。探索患者的经验和卫生经济学分析将是不可或缺的利益评估患者和国民保健服务。本试验于2012年7月10日在当前对照试验中注册（注册号：ISRCTN 12376468）。
The single most distressing symptom for patients with advanced esophageal cancer is dysphagia. Amongst the more effective treatments for relief of dysphagia is insertion of a self-expanding metal stent (SEMS). It is possible that the addition of a palliative dose of external beam radiotherapy may prolong the relief of dysphagia and provide additional survival benefit. The ROCS trial will assess the effect of adding palliative radiotherapy after esophageal stent insertion. The study is a randomized multicenter phase III trial, with an internal pilot phase, comparing stent alone versus stent plus palliative radiotherapy in patients with incurable esophageal cancer. Eligible participants are those with advanced esophageal cancer who are in need of stent insertion for primary management of dysphagia. Radiotherapy will be administered as 20 Gray (Gy) in five fractions over one week or 30 Gy in 10 fractions over two weeks, within four weeks of stent insertion. The internal pilot will assess rates and methods of recruitment; pre-agreed criteria will determine progression to the main trial. In total, 496 patients will be randomized in a 1:1 ratio with follow up until death. The primary outcome is time to progression of patient-reported dysphagia. Secondary outcomes include survival, toxicity, health resource utilization, and quality of life. An embedded qualitative study will explore the feasibility of patient recruitment by examining patients’ motivations for involvement and their experiences of consent and recruitment, including reasons for not consenting. It will also explore patients’ experiences of each trial arm. The ROCS study will be a challenging trial studying palliation in patients with a poor prognosis. The internal pilot design will optimize methods for recruitment and data collection to ensure that the main trial is completed on time. As a pragmatic trial, study strengths include collection of all follow-up data in the usual place of care, and a focus on patient-reported, rather than disease-orientated, outcomes. Exploration of patient experience and health economic analyses will be integral to the assessment of benefit for patients and the NHS. The trial was registered with Current Controlled Trials (registration number: ISRCTN12376468) on 10 July 2012.
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影响因子：
19.7
作者：
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通讯作者：
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