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Japanese Journal of Clinical Oncology Advance Access published online on February 12, 2008
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hym178
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© The Author (2008). Published by Oxford University Press. All rights reserved

Randomized Phase III Trial of Adjuvant Chemotherapy with Gemcitabine versus S-1 in Patients with Resected Pancreatic Cancer: Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC-01)

Atsuyuki Maeda1, Narikazu Boku2, Akira Fukutomi2,, Satoshi Kondo3, Taira Kinoshita4, Masato Nagino5 and Katsuhiko Uesaka1

1 Division of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center Hospital, Shizuoka
2 Division of Gastrointestinal Oncology, Shizuoka Cancer Center Hospital, Shizuoka
3 Department of Surgical Oncology, Graduate School of Medicine, Hokkaido University, Sapporo
4 Upper Gastric Surgery, National Cancer Institute East Hospital, Chiba
5 Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan

For reprints and all correspondence: Atsuyuki Maeda, Shizuoka Cancer Center Hospital, Division of Hepato-Biliary-Pancreatic Surgery, 1007 Shimo-Nagakubo, Sunto-Nagaizumi, Shizuoka, 411-8777 Japan. E-mail: a.maeda{at}scchr.jp

Received October 12, 2007; accepted December 19, 2007

A randomized controlled trial has begun in Japan to compare orally administered S-1 with intravenous gemcitabine (GEM) as adjuvant chemotherapy for patients with curatively resected pancreatic cancer. Patients are enrolled within 10 weeks after pancreatectomy to be treated for six months after assignment to either S-1 (80 mg/m2/day for four weeks, repeated similarly every six weeks for a total of four courses) or GEM (1000 mg/m2 on days 1, 8 and 15, repeated similarly every four weeks for a total of six courses). The primary endpoint is overall survival; secondary endpoints include relapse-free survival, incidence of adverse events and health-related quality of life. Each treatment arm includes 180 patients, providing an expected hazard ratio of 0.87 and an upper margin of 1.25 (two-sided alpha-error, 0.05; power, 0.8). Follow-up abdominal computed tomography is repeated every three months during the first two years, then every six months for three years.

Key Words: pancreatic cancer • adjuvant chemotherapy • gemcitabine • S-1 • phase III


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