NCT01285557

Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial

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 Untreated With Chemotherapy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 361 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 gastro-esophageal junction cancer previously untreated with chemotherapy.

Detailed description

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).

Conditions

• Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction

Interventions

Type	Name	Description
DRUG	S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm)	25 mg/m² body surface area (BSA) orally 2 times daily from Days 1 through 21 followed by a 7 day rest period, plus cisplatin 75 mg/m2 BSA on Day 1 each 28 day cycle Number of Cycles: until progression or unacceptable toxicity develops. Treatment with cisplatin is limited to a maximum of 8 cycles.
DRUG	Fluorouracil/cisplatin (control arm)	5-FU: 800 mg/m2 BSA/24 hours by continuous intravenous infusion (CIV) from Days 1 through 5 plus cisplatin 80 mg/m2 BSA on Day 1 each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. Treatment with cisplatin is limited to a maximum of 8 cycles.

Timeline

• Start date: 2011-04-14
• Primary completion: 2014-08-15
• Completion: 2014-08-15
• First posted: 2011-01-28
• Last updated: 2024-09-19
• Results posted: 2022-05-17

Locations

87 sites across 20 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Croatia, Estonia, Germany, Hungary, Israel, Italy, Mexico, Poland, Portugal, Romania, Russia, South Africa, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study