CoCStom - Randomised trial comparing completeness of adjuvant chemotherapy after early vs. late diverting stoma closure in low anterior resection for rectal cancer

CoCStom - 比较直肠癌低位前切除术后早期与晚期改道造口闭合后辅助化疗完整性的随机试验

• 批准号: 223460251
• 负责人: Dr. Flavius Sandra-Petrescu
• 金额: --
• 依托单位: Chirurgische Klinik
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2013
• 资助国家: 德国
• 起止时间: 2012-12-31 至 2022-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/223460251?language=en
• 关键词: CoCStom; Randomised; trial; comparing; completeness

Diverting stoma was shown to reduce clinical severity of anastomotic leakage in patients undergoing low anterior resection (LAR) with total mesorectal excision for locally advanced rectal cancer. The standard of care is stoma closure after completion of adjuvant chemotherapy (control group). Two randomized multicentre trials show that early closure (EC) is feasible without a major increase of the complication rate. No information is provided on the influence of EC on completeness of chemotherapy (CoC). Adjuvant chemotherapy represents a cornerstone in the multimodal treatment of locally advanced cancer. An exploratory analysis of a multicentre study suggests that CoC is associated with better oncological outcome. How timing of stoma closure influences CoC is still unclear. EC may have positive (by avoiding stoma related morbidity) or negative (due to postoperative complications) impact on CoC. CoCStom is a randomised multicentre trial comparing CoC as primary endpoint after early (8-10 days after tumor resection) vs. late (~26 weeks after tumor resection after completion of adjuvant therapy) stoma closure in patients with locally advanced rectal cancer undergoing LAR after neoadjuvant therapy. An increase of 20% for the rate of CoC is regarded as a clinically meaningful step forward and serves as basis for the sample size calculation. Quality of life and oncological outcome are key secondary endpoints. CoCStom’s objective is to clarify the optimal timing of stoma closure in the context of adjuvant chemotherapy. 224 of 257 patients have been recruited since December 2013.

在局部晚期直肠癌行低位前切除术（LAR）加全肠系膜切除术的患者中，转移造口术可降低吻合口漏的临床严重程度。治疗标准为辅助化疗完成后闭合造口（对照组）。两项随机多中心试验表明，在并发症发生率没有显著增加的情况下，早期闭合（EC）是可行的。没有关于EC对化疗完成度（CoC）的影响的信息。辅助化疗是局部晚期癌症多模式治疗的基石。一项多中心研究的探索性分析表明，CoC与更好的肿瘤预后相关。造口关闭的时间如何影响CoC尚不清楚。EC对CoC的影响可能是积极的（通过避免造口相关的发病率）或消极的（由于术后并发症）。CoCStom是一项随机多中心试验，比较局部晚期直肠癌患者在接受新辅助治疗后早期（肿瘤切除后8-10天）和晚期（肿瘤切除后完成辅助治疗后约26周）造口后CoC作为主要终点。CoC率增加20%被认为是有临床意义的进步，并作为计算样本量的基础。生活质量和肿瘤预后是关键的次要终点。CoCStom的目的是阐明在辅助化疗的情况下关闭造口的最佳时机。自2013年12月以来，257名患者中有224人被招募。