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Japanese Journal of Clinical Oncology Advance Access published online on June 21, 2007
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hym046
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© 2007 Foundation for Promotion of Cancer Research

A Randomized Phase II Selection Trial in Patients with Advanced/Recurrent Gastric Cancer: Trial for Advanced Stomach Cancer (TASC)

Satoshi Morita1,, Hideo Baba2, Akira Tsuburaya3, Hiroya Takiuchi4, Takanori Matsui5, Yoshihiko Maehara6 and Junichi Sakamoto1

1 Department of Medical Administration, Program in Health and Community Medicine, Nagoya University Graduate School of Medicine, Nagoya
2 Department of Gastroenterological Surgery, Graduate School of Medical Science, Kumamoto University, Kumamoto
3 Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama
4 Second Department of Internal Medicine, Osaka Medical College, Osaka
5 Department of Clinical Research, Aichi Cancer Center Aichi Hospital, Aichi
6 Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan

For reprints and all correspondence: Satoshi Morita, Department of Medical Administration, Program in Health and Community Medicine, Nagoya University Graduate School of Medicine, 65 Tsuruma-Cho, Showa-Ku, Nagoya, 466-8550, Japan. E-mail: smorita{at}med.nagoya-u.ac.jp

Received December 15, 2006; accepted January 28, 2007

A randomized phase II clinical trial is being conducted for patients with advanced or recurrent gastric cancer, in order to select the most promising treatment for subsequent evaluation in a large-scale phase III trial. We compare four chemotherapeutic treatments, which include two sequential and two combination regimens using paclitaxel with 5-fluorouracil or S-1, an oral fluorouracil derivative. The primary endpoint is 10-month overall survival rate, while the secondary endpoints are adverse events, time to treatment failure and progression-free survival. A Bayesian method is used to provide a statistical rule for monitoring the trial. Forty patients per treatment regimen (160 in total) were randomized into one of the four regimens using a centralized dynamic method.

Key Words: Randomized phase II trial • gastric cancer • chemotherapy • Bayesian trial monitoring


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