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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
1,035
Capecitabine will be administered orally at 1000 mg/m\^2 BID on Days 1 to 15 of a 3-week cycle, for 8 cycles.
Oxaliplatin will be administered as an IV infusion, 130 mg/m\^2 on Day 1 of each 3-week cycle for 8 cycles.
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Fujian, China
Unnamed facility
Guangzhou, China
Unnamed facility
Guangzhou, China
Unnamed facility
Shanghai, China
Unnamed facility
Shanghai, China
Unnamed facility
Shenyang, China
Unnamed facility
Tianjin, China
Unnamed facility
Bundang City, South Korea
...and 26 more locations
Disease-free survival rate
Time frame: 3 years
Overall survival
Time frame: 5 years
Incidence of adverse events
Time frame: 5 years
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