Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial
Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial
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.
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).
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