An open-label multicenter, randomized, phase 3 study of S-1 in combination with cisplatin against 5-Fu [fluorouracil] in combination with cisplatin in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease.

Trial Profile

An open-label multicenter, randomized, phase 3 study of S-1 in combination with cisplatin against 5-Fu [fluorouracil] in combination with cisplatin in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease.

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jul 2017

At a glance

  • Drugs Gimeracil/oteracil/tegafur (Primary) ; Cisplatin; Fluorouracil
  • Indications Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms FLAGS
  • Sponsors Taiho Pharmaceutical
  • Most Recent Events

    • 06 Jun 2017 Results (n=889) of an analysis discovering clinically significant covariate model to identify a patient population with longer survival presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
    • 02 Oct 2012 Results of a non-inferiority analysis presented at the 37th Congress of the European Society for Medical Oncology.
    • 15 Mar 2011 S 1 was approved in the EU based in part on the results from this trial.
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