Study protocol of the SACURA trial: a randomized phase III trial of efficacy and safety of UFT as adjuvant chemotherapy for stage II colon cancer

BMC Cancer

Study Protocol

Satoshi Teramukai¹  Shigeyuki Matsui²  Yukihide Kanemitsu³  Keiichi Takahashi⁴  Naohiro Tomita⁵  Masahiko Watanabe⁶  Hidetaka Mochizuki⁷  Hideki Ueno⁷  Kenjiro Kotake⁸  Megumi Ishiguro⁹  Kenichi Sugihara⁹  Toshiaki Ishikawa^1,10  Hiroyuki Uetake^1,10  Yasuhiro Shimada^1,11 

[1] Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, 54 Shogoin-kawaharacho, 606-8507, Sakyo-ku, Kyoto, Japan;Department of Data Science, the Institute of Statistical Mathematics, 10-3 Midori-cho, 190-8562, Tachikawa, Tokyo, Japan;Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, 464-8681, Nagoya, Aichi, Japan;Department of Surgery, Cancer and Infectious Diseases Center Komagome Hospital, 18-22, Honkomagome 3-chome, 113-8677, Bunkyo-ku, Tokyo, Japan;Department of Surgery, Hyogo College of Medicine, 1-1 Mukogawa-cho, 663-8501, Nishinomiya, Hyogo, Japan;Department of Surgery, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, 252-0375, Sagamihara, Kanagawa, Japan;Department of Surgery, National Defense Medical College, 3-2 Namiki, 359-8513, Tokorozawa, Saitama, Japan;Department of Surgery, Tochigi Cancer Center, 4-9-13 Yonan, 320-0834, Utsunomiya, Tochigi, Japan;Department of Surgical Oncology, Tokyo Medical and Dental University, Graduate School, 1-5-45 Yushima, 113-8519, Bunkyo-ku, Tokyo, Japan;Department of Translational Oncology, Tokyo Medical and Dental University, Graduate School, 1-5-45 Yushima, 113-8519, Bunkyo-ku, Tokyo, Japan;Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, 104-0045, Chuo-ku, Tokyo, Japan;

关键词: Colon cancer;    Stage II;    Adjuvant chemotherapy;    UFT;    Risk factor;    Predictive factor;    Prognostic factor;    Surgery-alone;    Randomized controlled trial;    Japan;   

DOI  :  10.1186/1471-2407-12-281

 received in 2012-02-17, accepted in 2012-06-21,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundAdjuvant chemotherapy for stage III colon cancer is internationally accepted as standard treatment with established efficacy, but the usefulness of adjuvant chemotherapy for stage II colon cancer remains controversial. The major Western guidelines recommend adjuvant chemotherapy for “high-risk stage II” cancer, but this is not clearly defined and the efficacy has not been confirmed.Methods/designSACURA trial is a multicenter randomized phase III study which aims to evaluate the superiority of 1-year adjuvant treatment with UFT to observation without any adjuvant treatment after surgery for stage II colon cancer in a large population, and to identify “high-risk factors of recurrence/death” in stage II colon cancer and predictors of efficacy and adverse events of the chemotherapy. Patients aged between 20 and 80 years with curatively resected stage II colon cancer are randomly assigned to a observation group or UFT adjuvant therapy group (UFT at 500–600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by 2-day rest. This 1-week treatment cycle is repeated for 1 year). The patients are followed up for 5 years until recurrence or death. Treatment delivery and adverse events are entered into a web-based case report form system every 3 months. The target sample size is 2,000 patients. The primary endpoint is disease-free survival, and the secondary endpoints are overall survival, recurrence-free survival, and incidence and severity of adverse events. In an additional translational study, the mRNA expression of 5-FU-related enzymes, microsatellite instability and chromosomal instability, and histopathological factors including tumor budding are assessed to evaluate correlation with recurrences, survivals and adverse events.DiscussionA total of 2,024 patients were enrolled from October 2006 to July 2010. The results of this study will provide important information that help to improve the therapeutic strategy for stage II colon cancer.Trial registrationClinicalTrials.gov NCT00392899.

【 授权许可】

Unknown   
© Ishiguro et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.