Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Oncology, Inc.
• Treatments: Cisplatin; Fluorouracil; Tegafur

Criteria

Inclusion Criteria:

• Has given written Informed Consent

• Histologically confirmed, unresectable, metastatic diffuse gastric cancer including carcinoma of the gastro-esophageal junction

• No prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant chemotherapy more than 12 months ago

• Life expectancy of at least 3 months

• Able to take medications orally

• ECOG performance status 0 to 1

• Adequate organ function (bone marrow, kidney and liver)

Exclusion Criteria:

• Certain type(s) of non-measurable lesion(s), if the only one(s).

• Certain serious illness or medical condition(s)

• Lost greater than or equal to 10% of body weight in the 3 months proceeding signing the ICF

• Treatment with drugs interacting with S-1, 5-FU, or cisplatin.

• Pregnant or lactating female.

• Known hypersensitivity to fluoropyrimidines or cisplatin.

Other protocol-defined inclusion/exclusion criteria may apply