A comparison of multimodality treatment: two or four courses of paclitaxel plus cisplatin or S-1 plus cisplatin followed by surgery for locally advanced gastric cancer, a randomized Phase II trial (COMPASS)

Jpn J Clin Oncol. 2010 Apr;40(4):369-72. doi: 10.1093/jjco/hyp178. Epub 2010 Mar 18.

Abstract

This randomized Phase II trial compares neoadjuvant chemotherapy of two or four courses of S-1 (1 M tegafur-0.4 M gimestat-1 M ostat potassium) plus cisplatin or paclitaxel plus cisplatin by a two-by-two factorial design for patients with macroscopically resectable locally advanced gastric cancer. The primary endpoint is the 3-year overall survival. The sample size is 60-80 in a total for two hypotheses of the superiority of four courses to two courses and the superiority of paclitaxel plus cisplatin to S-1 plus cisplatin. In both arms, S-1 is strongly recommended post-operatively for at least 6 months but no adjuvant chemotherapy is permitted other than S-1 until recurrence. This trial could appraise more suitable cycles and regimen as neoadjuvant chemotherapy for gastric cancer.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Cisplatin / administration & dosage
  • Cisplatin / adverse effects
  • Combined Modality Therapy
  • Digestive System Surgical Procedures*
  • Drug Combinations
  • Humans
  • Neoadjuvant Therapy
  • Oxonic Acid / administration & dosage
  • Oxonic Acid / adverse effects
  • Paclitaxel / administration & dosage
  • Paclitaxel / adverse effects
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / pathology
  • Stomach Neoplasms / surgery*
  • Tegafur / administration & dosage
  • Tegafur / adverse effects

Substances

  • Drug Combinations
  • S 1 (combination)
  • Tegafur
  • Oxonic Acid
  • Paclitaxel
  • Cisplatin