Clinical Trial: Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: An Open-Label, Multicenter, Randomized, Phase 3 Study of S-1 and Cisplatin Compared With 5-FU and Cisplatin in Patients With Metastatic Diffuse Gastric Cancer Previously U
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and esophagogastric junction cancer previously untreated with chemotherapy.
Detailed Summary: This is an open-label, international, Phase 3 study evaluating the efficacy and safety of the S-1/cisplatin regimen versus the 5-FU/cisplatin regimen in chemotherapy-naïve patients with metastatic diffuse gastric carcinoma including carcinoma of the gastro-esophageal junction. Patients will be randomly assigned to S-1/cisplatin (experimental regimen, Arm A) or 5-FU/cisplatin (control regimen, Arm B).
Sponsor: Taiho Oncology, Inc.
Current Primary Outcome: Outcome Measure: Overall survival (OS) [ Time Frame: 12 months after the last patient is randomized or the target number of events is reached, whichever is later ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Progression-free survival (PFS) [ Time Frame: Throughout ]
- Time to treatment failure (TTF) [ Time Frame: Throughout ]
- Antitumor activity: Overall Response Rate (ORR), duration of response (DR), time to tumor response (TTR); [ Time Frame: Throughout ]
- Safety and tolerability [ Time Frame: Treatment period ]
Original Secondary Outcome: Same as current
Information By: Taiho Oncology, Inc.
Dates:
Date Received: January 26, 2011
Date Started: February 2011
Date Completion: May 2017
Last Updated: October 19, 2016
Last Verified: October 2016
