Conditions: Gastric Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 36
Healthy volunteers: no

Brief summary:
This study will evaluate the disease free survival rate of a combination of capecitabine \[Xeloda\] and oxaliplatin (XELOX) with trastuzumab \[Herceptin\] in patients with resectable gastric cancer. The combination of Xeloda (orally, 1000 mg/m2 on day 1-14 of every cycle) and Herceptin (intravenously, 8 mg/kg loading dose, then 6 mg/kg on days 1-14 of every cycle) will be administered for three cycles prior to surgery to resect the tumor. If complete resection, R0 or microscopic residual tumor R1 is achieved, patients will continue with three cycles of XELOX and Herceptin and then for completion of 12 months treatment with Herceptin alone. Oxaliplatin will be administered intravenously at a dose of 130 mg/m2 on day 1 in every cycle. The anticipated time on study drug will be 12 months.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Capecitabine [Xeloda] intervention 2: Oxaliplatin intervention 3: Trastuzumab [Herceptin]
Intervention descriptions: intervention 1: 1.000 mg/m2 orally every 12 hours from day 1 to day 14 of every cycle for 6 cycles intervention 2: 130 mg/m2 intravenous infusion day 1 of every cycle intervention 3: First dose 8 mg/kg, subsequent cycles 6 mg/kg, intravenously, day of every cycle for 15 cycles

Protocol document: