JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Department of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, Japan.
Jpn J Clin Oncol. 2020 Aug 4;50(8):953-957. doi: 10.1093/jjco/hyaa058.
A randomized phase III trial was initiated in Japan in August 2019 to confirm the superiority of preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy compared to the standard treatment, i.e. surgery plus adjuvant chemotherapy, for locally recurrent rectal cancer in local relapse-free survival. In all, 110 patients from 43 Japanese institutions will be recruited over a period of 6 years. Eligible patients would be registered and randomly assigned to each group with an allocation ratio of 1:1. The primary endpoint is local relapse-free survival. The secondary endpoints are overall survival, relapse-free survival, proportion of local relapse, proportion of distant relapse, proportion of patients with pathological R0 resection, response rate of preoperative chemoradiotherapy (preoperative chemoradiotherapy arm), pathological complete response rate (preoperative chemoradiotherapy arm), proportion of patients who completed the protocol treatment, incidence of adverse events (adverse reactions) and quality of life after surgery. This trial has been registered at the Japan Registry of Clinical Trial: jRCTs031190076 [https://jrct.niph.go.jp/latest-detail/jRCTs031190076] and ClinicalTrials.gov: NCT04288999 [https://clinicaltrials.gov/ct2/show/NCT04288999].
一项针对日本局部复发性直肠癌患者的随机 III 期临床试验于 2019 年 8 月启动，旨在确认术前放化疗联合手术加辅助化疗优于标准治疗（即手术加辅助化疗），以提高局部无复发生存率。在 6 年的时间里，来自 43 家日本机构的 110 名患者将被纳入该研究。符合条件的患者将被登记并随机分配到每组，分配比例为 1:1。主要终点是局部无复发生存率。次要终点包括总生存率、无复发生存率、局部复发率、远处复发率、病理 R0 切除率、术前放化疗的反应率（术前放化疗组）、病理完全缓解率（术前放化疗组）、完成方案治疗的患者比例、不良事件（不良反应）发生率和术后生活质量。该试验已在日本临床试验注册中心注册：jRCTs031190076 [https://jrct.niph.go.jp/latest-detail/jRCTs031190076]，并在美国临床试验注册中心注册：NCT04288999 [https://clinicaltrials.gov/ct2/show/NCT04288999]。
