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Japanese Journal of Clinical Oncology Advance Access originally published online on June 27, 2006
Japanese Journal of Clinical Oncology 2006 36(8):519-522; doi:10.1093/jjco/hyl048
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© 2006 Foundation for Promotion of Cancer Research

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 Ueda1, Takashi Fujimura2, Shinichi Kinami2, Yasuo Hirono3, Akio Yamaguchi3, Hiroyuki Naitoh4, Tohru Tani4, Masahide Kaji5, Hisakazu Yamagishi1, Koichi Miwa2,6 for HKIT-GC

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

For reprints and all correspondence: Yuji Ueda, Department of Surgery and Oncology of Digestive System, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan. E-mail: yueda{at}koto.kpu-m.ac.jp

Received April 7, 2006; accepted May 1, 2006

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.

Key Words: gastric cancer • adjuvant chemotherapy • immunotherapy • S-1 • PSK


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