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 Takahashi, Junichi Sakamoto, Tetsuo Takeuchi, Masayoshi Mai, Tetsuro Kubota, Masaki Kitajima, Yusuke Tanigawara, Yoshito Komatsu, Tetsuya Toge, Shigetoyo Saji

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8 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)342-345
Number of pages4
JournalJapanese journal of clinical oncology
Issue number6
Publication statusPublished - 2004 Jun 1



  • CPT-11
  • Gastric cancer
  • S-1
  • Tailored dose chemotherapy

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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