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Japanese Journal of Clinical Oncology 2004 34(6):342-345; doi:10.1093/jjco/hyh067
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© 2004 Foundation for Promotion of Cancer Research

A Randomized Phase II Clinical Trial of Tailored CPT-11 + S-1 vs S-1 in Patients with Advanced or Recurrent Gastric Carcinoma as the First Line Chemotherapy

Yutaka Takahashi1, Junichi Sakamoto2, Tetsuo Takeuchi3, Masayoshi Mai1, Tetsuro Kubota4, Masaki Kitajima4, Yusuke Tanigawara5, Yoshito Komatsu6, Tetsuya Toge7 and Shigetoyo Saji3,+

1 Department of Surgical Oncology, Cancer Research Institute, Kanazawa University, Kanazawa, 2 Department of Epidemiological and Clinical Information Management, Kyoto University, Kyoto, 3 Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, 4 Department of Surgery and 5 Department of Pharmacy, Keio University School of Medicine, Tokyo, 6 Department of Gastroenterology, Hokkaido University School of Medicine, Sapporo and 7 Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan

A randomized phase II clinical trial has been designed and started in the Japanese Foundation for Multidisciplinary Treatment of Cancer (JFMC) to select the better regimen between tailored CPT-11 + S-1 and the standard S-1 treatment for advanced or recurrent gastric cancer as the first line chemotherapy. Selection of the better treatment for general clinical practice in this clinical trial will lead to a more precise assignment of a promising regimen for a future phase III randomized trial, placing continuous 5-FU infusion as the reference arm. In this trial, subsidiary pharmacokinetic analysis for the tailored dose arm is also proposed. In order to continue chemotherapy for a long time and to obtain longer survival, our study design for the tailored therapy could be exploited, especially in the field of general clinical practice.

+ For reprints and all correspondence: Yutaka Takahashi, Department of Surgical Oncology, Cancer Research Institute, Kanazawa University, 13–1 Takaramachi, Kanazawa 920-8640, Japan. E-mail:takahasi{at}kenroku.kanazawa-u.ac.jp


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