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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.

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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.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Aug 2024

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At a glance

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

Most Recent Events

  • 12 Sep 2017 Results of identification of patient population with longer survival by using clinical covariate model data from FLAGS and DIGEST phase III trials presented at the 42nd European Society for Medical Oncology Congress
  • 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.

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