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

Research output: Contribution to journalArticle

8 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)342-345
Number of pages4
JournalJapanese Journal of Clinical Oncology
Volume34
Issue number6
DOIs
Publication statusPublished - 2004 Jun 1

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irinotecan
Phase II Clinical Trials
Stomach
Randomized Controlled Trials
Carcinoma
Drug Therapy
General Practice
Therapeutics
Fluorouracil
Stomach Neoplasms
Pharmacokinetics
Clinical Trials
Survival

Keywords

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

ASJC Scopus subject areas

  • Oncology

Cite this

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

In: Japanese Journal of Clinical Oncology, Vol. 34, No. 6, 01.06.2004, p. 342-345.

Research output: Contribution to journalArticle

Takahashi, Yutaka ; Sakamoto, Junichi ; Takeuchi, Tetsuo ; Mai, Masayoshi ; Kubota, Tetsuro ; Kitajima, Masaki ; Tanigawara, Yusuke ; Komatsu, Yoshito ; Toge, Tetsuya ; Saji, Shigetoyo. / 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. In: Japanese Journal of Clinical Oncology. 2004 ; Vol. 34, No. 6. pp. 342-345.
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