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

在局部进展期直肠癌行低位前切除术（LAR）联合全直肠系膜切除术的患者中，转移吻合口可降低吻合口瘘的临床严重程度。护理标准是在完成辅助化疗后关闭造口（对照组）。两项随机多中心试验表明，早期闭合（EC）是可行的，不会显著增加并发症发生率。未提供EC对化疗完成性（CoC）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与更好的肿瘤结局相关。造口关闭的时机如何影响CoC仍不清楚。EC可能对CoC产生积极（通过避免造口相关发病率）或消极（由于术后并发症）影响。CoCStom是一项随机多中心试验，比较了CoC作为新辅助治疗后接受LAR的局部晚期直肠癌患者早期（肿瘤切除后8-10天）与晚期（肿瘤切除后完成辅助治疗后约26周）造口闭合后的主要终点。CoC率增加20%被视为具有临床意义的进步，并作为样本量计算的基础。生活质量和肿瘤学结局是关键次要终点。CoCStom的目的是阐明在辅助化疗的背景下，吻合口闭合的最佳时机。自2013年12月以来，257例患者中有224例被招募。

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.