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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

Megumi Ishiguro1, Hidetaka Mochizuki2, Naohiro Tomita3, Yasuhiro Shimada4, Keiichi Takahashi5, Kenjiro Kotake6, Masahiko Watanabe7, Yukihide Kanemitsu8, Hideki Ueno2, Toshiaki Ishikawa9, Hiroyuki Uetake9, Shigeyuki Matsui10, Satoshi Teramukai11 and Kenichi Sugihara1*

Author Affiliations

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

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

3 Department of Surgery, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan

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

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

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

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

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

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

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

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

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BMC Cancer 2012, 12:281  doi:10.1186/1471-2407-12-281

Published: 7 July 2012

Abstract

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.

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