Conditions: Gastric Cancer
Keywords: Gastric Cancer Cetuximab EMD271786 TS-1 Cisplatin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

Brief summary:
This open-label, single-arm, multicenter, Phase 2 trial will treat at least 40 participants with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction (GEJ) who have not previously received systemic chemotherapy for this setting.

All eligible participants will receive the combination of cetuximab plus S-1 (a combination of tegafur, gimeracil, and oteracil) and cisplatin.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Cetuximab intervention 2: Cisplatin intervention 3: S-1
Intervention descriptions: intervention 1: Single first dose of cetuximab 400 milligram per square meter (mg/m\^2) will be administered intravenously followed by once weekly subsequent intravenous infusion of cetuximab 250 mg/m\^2 in each 5-week treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent. intervention 2: Cisplatin 60 mg/m\^2 will administered as intravenous infusion on Day 8 of each 5-week cycle maximum up to 8 cycles until disease progression, unacceptable toxicity, or withdrawal of consent intervention 3: S-1, a combination of tegafur, gimeracil, and oteracil will be administered intravenously at a dose of 40 to 60 mg/m\^2 orally twice daily for first three consecutive weeks of 5-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.

Protocol document: