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

Megumi Ishiguro⁹  Hidetaka Mochizuki¹  Naohiro Tomita¹¹  Yasuhiro Shimada⁷  Keiichi Takahashi⁶  Kenjiro Kotake⁸  Masahiko Watanabe³  Yukihide Kanemitsu¹⁰  Hideki Ueno¹  Toshiaki Ishikawa⁵  Hiroyuki Uetake⁵  Shigeyuki Matsui²  Satoshi Teramukai⁴  Kenichi Sugihara⁹ 

[1] Department of Surgery, National Defense Medical College, 3-2 Namiki, Tokorozawa, Saitama, 359-8513, Japan

[2] Department of Data Science, the Institute of Statistical Mathematics, 10-3 Midori-cho, Tachikawa, Tokyo, 190-8562, Japan

[3] Department of Surgery, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0375, Japan

[4] Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, 54 Shogoin-kawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan

[5] Department of Translational Oncology, Tokyo Medical and Dental University, Graduate School, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan

[6] Department of Surgery, Cancer and Infectious Diseases Center Komagome Hospital, 18-22, Honkomagome 3-chome, Bunkyo-ku, Tokyo, 113-8677, Japan

[7] Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

[8] Department of Surgery, Tochigi Cancer Center, 4-9-13 Yonan, Utsunomiya, Tochigi, 320-0834, Japan

[9] Department of Surgical Oncology, Tokyo Medical and Dental University, Graduate School, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan

[10] Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan

[11] Department of Surgery, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan

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

Others  :  1080326
DOI  :  10.1186/1471-2407-12-281

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

【 摘 要 】

Background

Adjuvant 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/design

SACURA 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.

Discussion

A 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 registration

ClinicalTrials.gov NCT00392899.

【 授权许可】

   
2012 Ishiguro et al.; licensee BioMed Central Ltd.

【 图 表 】

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