SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during operation for treatment of gastric cancer. The indication has bee approved by Chinese FDA. The study is a post-marketing study. The subjects will be divided into two groups (Group A and Group B ). The subject in Group A will receive D2 radical gastrectomy(R0),Sinofuan during operation and 6 cycles of Xelox adjuvant chemotherapy.The subject in Group B will receive D2 radical gastrectomy(R0),and 6 cycles of Xelox adjuvant chemotherapy. The subject's benefits from SinoFuan will be analyzed through comparing 3 years DFS of two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation.
Xelox regimes: Capecitabine,1000 mg/m2,PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2,IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished.
Heilongjiang Cancer Hospital
Harebin, Heilongjiang, China
RECRUITINGDFS (Disease Free Survival)
During 3 years of monitoring period, any cancer relapse will be recorded
Time frame: 3 year
adverse event
During 3 years of monitoring period, any AEs will be recorded
Time frame: 3 years
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