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Japanese Journal of Clinical Oncology Advance Access published online on June 27, 2006
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyl048
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© 2006 Foundation for Promotion of Cancer Research
Received April 7, 2006
Accepted May 1, 2006

Clinical Trial Note

A Randomized Phase III Trial of Postoperative Adjuvant Therapy with S-1 Alone versus S-1 plus PSK for Stage II/IIIA Gastric Cancer: Hokuriku-Kinki Immunochemo-Therapy Study Group-Gastric Cancer (HKIT-GC)

Yuji Ueda 1 *, Takashi Fujimura 2, Shinichi Kinami 2, Yasuo Hirono 3, Akio Yamaguchi 3, Hiroyuki Naitoh 4, Tohru Tani 4, Masahide Kaji 5, Hisakazu Yamagishi 1, and Koichi Miwa 6, for HKIT-GC

1 Department of Surgery and Oncology of Digestive System, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
2 Department of Gastroenterologic Surgery, Division of Cancer Medicine, Graduate School of Medical Science, Kanazawa University, Kanazawa, Japan
3 First Department of Surgery, Faculty of Medicine, University of Fukui, Fukui, Japan
4 Department of Surgery, Shiga University of Medical Science, Otsu, Japan
5 Department of Surgery, Toyama Prefectural Central Hospital, Toyama, Japan
6 Department of Gastroenterologic Surgery, Division of Cancer Medicine, Graduate School of Medical Science, Kanazawa University, Kanazawa, Japan; Department of Surgery, Toyama Rousai Hospital, Uozu, Toyama, Japan

* To whom correspondence should be addressed.
Yuji Ueda, E-mail: yueda{at}koto.kpu-m.ac.jp


  Abstract

In this randomized multicenter Phase III study, patients with curatively resected Stage II/IIIA gastric cancer were assigned to postoperative adjuvant therapy with an oral fluoropyrimidine S-1 alone (2 weeks of treatment and 1 week of rest for 6 months, followed by 2 weeks of treatment and 2 weeks of rest for 6 months) or S-1 combined with an oral biological response modifier PSK (the same regimen of S-1 plus daily PSK for 12 months). The main objective was to evaluate the survival benefit and quality of life (QOL) of combined therapy. The primary end points were the time to relapse and the duration of survival after surgery, i.e. the rates of disease-free survival and overall survival at 3 and 5 years. The secondary end points were the relations of survival rates to drug compliance, QOL, adverse events, postoperative complications, relapse status, and the preoperative expression of immune or tumor markers. The sample size was 140 per treatment arm.

Keywords: gastric cancer; adjuvant chemotherapy; immunotherapy; S-1; PSK.
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