JCOG Data Center/Operations Office, National Cancer Center Hospital, Chuo-ku, Japan.
Department of Gastroenterology and Endoscopy, National Cancer Center-Hospital East, Kashiwa, Chiba, Japan.
BMJ Open. 2020 Jul 14;10(7):e034947. doi: 10.1136/bmjopen-2019-034947.
Intestinal resection with lymph node dissection is the current standard treatment for high-risk lower rectal submucosal invasive cancer after local resection; however, surgery affects patients' quality of life due to stoma placement or impaired anal sphincter function. A recent study demonstrated that adjuvant chemoradiation yields promising results.
This study aims to confirm the non-inferiority of adjuvant chemoradiation, consisting of capecitabine and concurrent radiotherapy (45 Gy in 25 fractions), measured by 5-year relapse-free survival (RFS), over standard surgery in patients with high-risk lower rectal submucosal invasive cancer after local resection. The primary endpoint is 5 year RFS. The secondary endpoints are 10 years RFS, 5-year and 10-year overall survival, 5-year and 10-year local RFS, 5-year and 10-year proportion of anus-preservation without stoma, Wexner score, low anterior resection syndrome score, adverse events and serious adverse events. During the 5-year trial period, 210 patients will be accrued from 65 Japanese institutions.
The National Cancer Center Hospital East Certified Review Board approved this study protocol in October 2018. The study is conducted in accordance with the precepts established in the Declaration of Helsinki and Clinical Trials Act. Written informed consent will be obtained from all eligible patients prior to registration. The primary results of this study will be published in an English article. In addition, the main results will be published on the websites of Japan Clinical Oncology Group (www.jcog.jp) and jRCT (https://jrct.niph.go.jp/). As to data curation, it has not been prepared yet.
jRCT1031180076.
对于局部切除后的高危低位直肠黏膜下浸润性癌，肠切除术加淋巴结清扫是目前的标准治疗方法；然而，由于造口或肛门括约肌功能受损，手术会影响患者的生活质量。最近的一项研究表明，辅助放化疗效果较好。
本研究旨在证实卡培他滨联合同期放疗（45 Gy 分 25 次）辅助治疗高危低位直肠黏膜下浸润性癌患者的非劣效性，以 5 年无复发生存率（RFS）为测量指标，与局部切除后的标准手术相比。主要终点为 5 年 RFS。次要终点为 10 年 RFS、5 年和 10 年总生存率、5 年和 10 年局部 RFS、5 年和 10 年保肛率、Wexner 评分、低位前切除术综合征评分、不良事件和严重不良事件。在 5 年试验期间，将从 65 家日本机构中招募 210 名患者。
国家癌症中心医院东院认证审查委员会于 2018 年 10 月批准了该研究方案。本研究符合赫尔辛基宣言和临床试验法的规定。所有符合条件的患者在登记前将获得书面知情同意。本研究的主要结果将以英文文章发表。此外，主要结果将在日本临床肿瘤学会（www.jcog.jp）和 jRCT（https://jrct.niph.go.jp/）的网站上公布。至于数据管理，尚未准备。
jRCT1031180076。
