The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin combination chemotherapy based on the adverse events and survival period by performing a phase I/II study of this combination in patients with D2 resection of gastric cancer.
This stage I/II study is designed to evaluate the appropriate dose of S-1 plus fixed-dose of oxaliplatin (SOX regimen) for Patients with D2 resection of gastric cancer and survival of SOX regimen for stage II-III patients(AJCC 7th). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 3 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
71
60-90mg/m2/d P.O. day 1-14, repeated every 21 days
130mg/m2 d1 repeated every 21 days
Department of Medical Oncology,Cancer hospital and Institute,CAMS
Beijing, China
chemotherapy complete rate
percentage of patients who completed eight cycles of chemotherapy
Time frame: 6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
assessed from surgery until 1 months after withdrawing from study
Time frame: 3 years
recurrence-free survival(RFS)
from the date of surgery until the occurrence of an event (relapse or death whichever came first)
Time frame: 3 years
overall survival(OS)
from the date of surgery to any cause of death
Time frame: 3 years
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