Clinical Trials and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan.
Jpn J Clin Oncol. 2011 May;41(5):713-7. doi: 10.1093/jjco/hyr028. Epub 2011 Apr 5.
A Phase I/II trial of chemoradiotherapy concurrent with S-1 plus mitomycin C in patients with clinical Stage II/III squamous cell carcinoma of the anal canal was started in Japan. The aim of this trial is to determine the recommended dose of S-1 combined with a fixed dose of mitomycin C plus radiotherapy in Phase I and to evaluate the efficacy and safety in Phase II. The primary endpoint for the Phase II part of this study is the proportion of 3-year event-free survival, in which the following are defined as events: disease progression, residual tumor at the end of chemoradiotherapy, colostomy or death, whichever comes first. Secondary endpoints are progression-free survival, proportion of complete response and adverse events. In the Phase II part of this study, a total of 65 patients will be enrolled from 42 institutions over 6 years.
一项在日本开展的临床 II/III 期肛管鳞癌患者同步放化疗联合 S-1 加丝裂霉素 C 的 I/II 期临床试验开始了。本试验的目的是在 I 期确定 S-1 联合固定剂量丝裂霉素 C 加放疗的推荐剂量，并在 II 期评估疗效和安全性。本研究 II 期部分的主要终点是 3 年无事件生存率，其中事件定义为疾病进展、放化疗结束时的残留肿瘤、结肠造口术或死亡，以先发生者为准。次要终点是无进展生存率、完全缓解比例和不良事件。在本研究的 II 期部分，将在 6 年内从 42 家机构共招募 65 名患者。
