A randomized phase II selection trial in patients with advanced/recurrent gastric cancer: Trial for Advanced Stomach Cancer (TASC)

Jpn J Clin Oncol. 2007 Jun;37(6):469-72. doi: 10.1093/jjco/hym046. Epub 2007 Jun 21.

Abstract

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.

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Antimetabolites, Antineoplastic / administration & dosage*
  • Antineoplastic Agents, Phytogenic / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Drug Combinations
  • Fluorouracil / administration & dosage*
  • Humans
  • Neoplasm Recurrence, Local
  • Oxonic Acid / administration & dosage*
  • Paclitaxel / administration & dosage*
  • Stomach Neoplasms / drug therapy*
  • Tegafur / administration & dosage*

Substances

  • Antimetabolites, Antineoplastic
  • Antineoplastic Agents, Phytogenic
  • Drug Combinations
  • S 1 (combination)
  • Tegafur
  • Oxonic Acid
  • Paclitaxel
  • Fluorouracil