Randomized phase II study of S-1 dosing schedule for resected colorectal cancer

BMC Cancer

Study Protocol

Taroh Satoh¹  Tsunekazu Mizushima²  Yuichiro Doki²  Masaki Mori²  Junichi Nishimura²  Hirofumi Yamamoto²  Taishi Hata²  Ichiro Takemasa²  Mamoru Uemura³  Takeshi Kato⁴  Mitsugu Sekimoto⁵  Masataka Ikeda⁵  Riichiro Nezu⁶  Chu Matsuda⁷  Masayuki Ohue⁸  Masakazu Ikenaga⁹  Junichi Hasegawa⁹  Tatsushi Shingai^1,10  Ken Nakata^1,11  Kohei Murata^1,12 

[1] Department of Frontier Science for Cancer and Chemotherapy, Graduate School of Medicine, Osaka University, Osaka, Japan;Department of Surgery, Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamada-oka, 565-0871, Suita City, Osaka, Japan;Department of Surgery, Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamada-oka, 565-0871, Suita City, Osaka, Japan;Department of Surgery, National Hospital Organization, Osaka National Hospital, Osaka, Japan;Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan;Department of Surgery, National Hospital Organization, Osaka National Hospital, Osaka, Japan;Department of Surgery, Nishinomiya Municipal Central Hospital, Hyogo, Japan;Department of Surgery, Osaka General Medical Center, Osaka, Japan;Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan;Department of Surgery, Osaka Rosai Hospital, Osaka, Japan;Department of Surgery, Osaka Saiseikai Senri Hospital, Osaka, Japan;Department of Surgery, Sakai City Hospital, Osaka, Japan;Department of Surgery, Suita Municipal Hospital, Osaka, Japan;

关键词: Colorectal cancer;    Randomized phase II;    S-1;    Dose schedule;   

DOI  :  10.1186/s12885-015-1476-6

 received in 2014-08-21, accepted in 2015-05-27,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundPostoperative adjuvant chemotherapy for patients with stage III Colorectal cancer (CRC) is now internationally accepted as standard care for improving patient outcomes. The Adjuvant Chemotherapy Trial of S-1 for Colorectal Cancer (ACTS-CC) confirmed the non-inferiority of S-1 to tegafur/urcail/leucovorin in terms of overall survival and disease-free survival in patients with stage III CRC after curative surgery. However, the 6-month completion rate of S-1 treatment was 76.5 % in the ACTS-CC. Therefore, treatment completion remains an unresolved problem.Methods/DesignA randomized phase II trial was designed to evaluate the efficacy and safety of oral daily administration and alternate-day administration of S-1 as adjuvant chemotherapy in curatively resected stage III CRC. Enrolled patients were assigned to either S-1 daily administration (Arm A) or alternate-day S-1 administration (Arm B). Assigned treatment will start within 8 weeks after surgery. In both arms, S-1 dosing (oral) will be based on body surface area (80 mg/day for body surface area < 1.25 m2, 100 mg/day for 1.25–1.5 m2, or 60 mg/day for > 1.5 m2). In Arm A, S-1 will be administered orally for 28 days, followed by a 14-day rest. Administration will be conducted for 24 weeks from the date of therapy start. In Arm B, S-1 will be administered orally on alternate days for 28 weeks from the date of the start of therapy. After treatment, all patients will be observed without additional therapy unless recurrent lesions or other cancer lesions occur. The primary endpoint is treatment completion rate. Secondary endpoints include 3-year disease-free survival, compliance, and adverse events.DiscussionPreviously, S-1 alternate-day intake maintained the efficacy of chemotherapy while reducing adverse effects for patients with R0-resected stage II/III gastric cancer. Improvement of chemotherapy completion rate for patients with colorectal cancer will lead to an improved patient prognosis. Therefore, a randomized phase II trial has been designed to examine the efficacy of alternate-day versus current standard daily S-1 administration as adjuvant chemotherapy for R0-resected stage III colorectal cancer.Trial registrationThis study was registered on 18 February 2014 with University Hospital Medical Information Network Clinical Trials Registry: UMIN000013185

【 授权许可】

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© Matsuda et al. 2016. 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/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.