BACKGROUND The variability of definitions for time-to-event (TTE) end-points impacts the conclusions of randomised clinical trials (RCTs). The Definition for the Assessment of Time-to-event Endpoints in CANcer (DATECAN) initiative aims to provide consensus definitions for TTE end-points used in RCTs. Here, we formulate guidelines for adjuvant colon cancer RCTs. METHODS We performed a literature review to identify TTE end-points and events included in their definition in RCT publications. Then, a consensus was reached among a panel of international experts, using a formal modified Delphi method, with 2 rounds of questionnaires and an in-person meeting. RESULTS Twenty-four experts scored 72 events involved in 6 TTE end-points. Consensus was reached for 24%, 57% and 100% events after the first round, second round and in-person meeting. For RCTs not using overall survival as their primary end-point, the experts recommend using disease-free survival (DFS) rather than recurrence-free survival (RFS) or time to recurrence (TTR) as the primary end-point. The consensus definition of DFS includes all causes of death, second primary colorectal cancers (CRCs), anastomotic relapse and metastatic relapse as an event, but not second primary non-CRCs. Events included in the RFS definition are the same as for DFS with the exception of second primary CRCs. The consensus definition of TTR includes anastomotic or metastatic relapse, death with evidence of recurrence and death from CC cause. CONCLUSION Standardised definitions of TTE end-points ensure the reproducibility of the end-points between RCTs and facilitate cross-trial comparisons. These definitions should be integrated in standard practice for the design, reporting and interpretation of adjuvant CC RCTs.

中文翻译：

---

局部结肠癌患者辅助随机试验中事件发生时间终点定义指南：DATECAN 计划的结果。


背景事件发生时间（TTE）终点定义的可变性影响随机临床试验（RCT）的结论。 CANcer 事件发生时间终点评估定义 (DATECAN) 计划旨在为 RCT 中使用的 TTE 终点提供共识定义。在这里，我们制定了结肠癌辅助随机对照试验指南。方法 我们进行了文献综述，以确定 RCT 出版物中定义中包含的 TTE 终点和事件。然后，国际专家小组采用正式的修正德尔菲法，通过两轮问卷调查和面对面会议达成共识。结果 24 名专家对涉及 6 个 TTE 终点的 72 个项目进行了评分。经过第一轮、第二轮和面对面会议后，达成共识的比例分别为 24%、57% 和 100%。对于不使用总生存期作为主要终点的随机对照试验，专家建议使用无病生存期（DFS）而不是无复发生存期（RFS）或复发时间（TTR）作为主要终点。 DFS 的共识定义包括所有死亡原因、第二原发性结直肠癌 (CRC)、吻合口复发和转移性复发作为事件，但不包括第二原发性非 CRC。 RFS 定义中包含的事件与 DFS 相同，但第二个主要 CRC 除外。 TTR 的共识定义包括吻合口或转移性复发、有复发证据的死亡以及 CC 原因导致的死亡。结论 TTE 终点的标准化定义确保了 RCT 之间终点的可重复性，并有利于跨试验比较。这些定义应纳入辅助 CC 随机对照试验的设计、报告和解释的标准实践中。