A randomized Phase III trial of adjuvant S-1 therapy vs. observation alone in resected biliary tract cancer: Japan Clinical Oncology Group Study (JCOG1202, ASCOT)

Jpn J Clin Oncol. 2018 Apr 1;48(4):392-395. doi: 10.1093/jjco/hyy004.

Abstract

No standard adjuvant treatment has been established for patients with curatively resected biliary tract cancer. S-1 has been reported to show promising efficacy with mild toxicity profiles in patients with advanced biliary tract cancer, and adjuvant S-1 therapy has been demonstrated to provide survival benefit in patients with resected gastric cancer and pancreatic cancer. The aim of this open-label, multicenter, randomized Phase III trial is to confirm that adjuvant chemotherapy with S-1 would prolong overall survival in patients with resected biliary tract cancer. This study was activated in September 2013. A total of 350 patients planned to be enrolled from 36 Japanese institutions over a period of 4 years. At July 2017, the protocol was revised to increase power from 70% to 80%. Therefore, the planned total sample size is 440. The primary endpoint is overall survival. This trial is registered with the UMIN Clinical Trials Registry as UMIN000011688.

Publication types

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

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Biliary Tract Neoplasms / drug therapy*
  • Chemotherapy, Adjuvant
  • Drug Combinations
  • Endpoint Determination
  • Female
  • Follow-Up Studies
  • Humans
  • Japan
  • Male
  • Medical Oncology*
  • Middle Aged
  • Observation*
  • Oxonic Acid / therapeutic use*
  • Pancreatic Neoplasms / drug therapy
  • Tegafur / therapeutic use*

Substances

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