Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo) Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study.
Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo) Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study.
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DOI：
10.1136/bmjopen-2017-019474
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发表时间：
2017-12-28
期刊：
影响因子：
2.9
通讯作者：
for STAR-TREC Collaborative Group
中科院分区：
文献类型：
--
作者：
Rombouts AJM;Al-Najami I;Abbott NL;Appelt A;Baatrup G;Bach S;Bhangu A;Garm Spindler KL;Gray R;Handley K;Kaur M;Kerkhof E;Kronborg CJ;Magill L;Marijnen CAM;Nagtegaal ID;Nyvang L;Peters FP;Pfeiffer P;Punt C;Quirke P;Sebag-Montefiore D;Teo M;West N;de Wilt JHW;for STAR-TREC Collaborative Group
全直肠系膜切除术(TME)是直肠癌有效的标准治疗方法，但其发病率较高，对低危癌症可能是过度治疗。这项研究旨在通过一项比较器官保存方法和标准TME手术的研究来确定国际招募的可行性。STAR-TREC试验是一项针对活检证实的直肠腺癌患者的多中心国际随机、三臂平行、II期可行性研究。这项试验是在英国伯明翰协调进行的，在荷兰的拉德布达马克和丹麦的欧登塞大学医院斯文德堡大学医院设有国家中心。CT和MRI分期为≤cT3b(最大可达5 mm的壁外扩散)N0M0的直肠癌患者可包括在内。患者将随机接受标准的TME手术(对照组)、使用长疗程同步放化疗的器官保存治疗或使用短疗程放射治疗的器官保存治疗。对于采用保留器官策略的患者，(化疗)放射治疗的临床反应决定了下一步的治疗步骤。在临床完全消退的情况下，将实施积极的监测制度。在临床不完全消退的情况下，患者将使用优化的平台进行局部切除，如经肛门内窥镜显微手术或其他经肛门技术(如经肛门内窥镜手术或经肛门微创手术)。这项第二阶段研究的主要终点是为了证明足够的国际招募，以便维持一项将骨盆衰竭作为主要终点的第三阶段研究。第二阶段的成功被定义为第一年国际上每月至少随机抽取四个病例，第二年国际上每月至少随机抽取六个病例。所有参与国家的医学伦理委员会都已批准了该研究方案。主要和次要终点的结果将提交同行评议的期刊发表。ISRCTN14240288,2016年10月20日。NCT02945566；预告，2016年10月。
Total mesorectal excision (TME) is the highly effective standard treatment for rectal cancer but is associated with significant morbidity and may be overtreatment for low-risk cancers. This study is designed to determine the feasibility of international recruitment in a study comparing organ-saving approaches versus standard TME surgery. STAR-TREC trial is a multicentre international randomised, three-arm parallel, phase II feasibility study in patients with biopsy-proven adenocarcinoma of the rectum. The trial is coordinated from Birmingham, UK with national hubs in Radboudumc (the Netherlands) and Odense University Hospital Svendborg UMC (Denmark). Patients with rectal cancer, staged by CT and MRI as ≤cT3b (up to 5 mm of extramural spread) N0 M0 can be included. Patients will be randomised to either standard TME surgery (control), organ-saving treatment using long-course concurrent chemoradiation or organ-saving treatment using short-course radiotherapy. For patients treated with an organ-saving strategy, clinical response to (chemo)radiotherapy determines the next treatment step. An active surveillance regime will be performed in the case of a complete clinical regression. In the case of incomplete clinical regression, patients will proceed to local excision using an optimised platform such as transanal endoscopic microsurgery or other transanal techniques (eg, transanal endoscopic operation or transanal minimally invasive surgery). The primary endpoint of this phase II study is to demonstrate sufficient international recruitment in order to sustain a phase III study incorporating pelvic failure as the primary endpoint. Success in phase II is defined as randomisation of at least four cases per month internationally in year 1, rising to at least six cases per month internationally during year 2. The medical ethical committees of all the participating countries have approved the study protocol. Results of the primary and secondary endpoints will be submitted for publication in peer-reviewed journals. ISRCTN14240288, 20 October 2016. NCT02945566; Pre-results, October 2016.
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