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 anal canal (JCOG0903: SMART-AC).
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| Abstract |
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.
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| Authors | Atsuo Takashima, Yasuhiro Shimada, Tetsuya Hamaguchi, Yoshinori Ito, Ayaka Nakano, Kenichi Nakamura, Taro Shibata, Haruhiko Fukuda, Yoshihiro Moriya, Colorectal Cancer Study Group of the Japan Clinical Oncology Group |
| Journal | Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 41 Issue 5 Pg. 713-7 (May 2011) ISSN: 1465-3621 [Electronic] England |
| PMID | 21467080 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study) |
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