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- Title
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.
- Authors
Takahashi, Yutaka; Sakamoto, Junichi; Takeuchi, Tetsuo; Mai, Masayoshi; Kubota, Tetsuro; Kitajima, Masaki; Tanigawara, Yusuke; Komatsu, Yoshito; Toge, Tetsuya; Saji, Shigetoyo
- Abstract
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.
- Publication
Japanese Journal of Clinical Oncology, 2004, Vol 34, Issue 6, p342
- ISSN
0368-2811
- Publication type
Article
- DOI
10.1093/jjco/hyh067