A Study of Capecitabine (Xeloda) in Combination Chemotherapy Versus Surgery Alone in Participants With Gastric Cancer
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
This study will compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation
alone in chemotherapy-naive participants who have undergone potentially curative resection
for gastric cancer. Participants will be randomized to either the chemotherapy arm or the
observation arm. Capecitabine will be administered orally, 1000 milligrams per meter-squared
(mg/m^2) twice daily (BID) on Days 1 to 15 of a 3-week cycle, for 8 cycles, and oxaliplatin
will be administered as an intravenous (IV) infusion, 130 mg/m^2 every 3 weeks for 8 cycles.
The anticipated time on study treatment in 6 months and the target sample size is 1024
individuals.