The purpose of this study is to demonstrate that capecitabine/oxaliplatin as perioperative chemotherapy is superior or not to operation directly for locally advanced gastric cancer in terms of 3 year disease-free survival (DFS) rate.
The patients of gastric cancer have been divided into two parts in random.The test group receive perioperative chemotherapy (XELOX) six cycles and the control group administrate the same program after operation. The two groups have the same staging and eligibility criteria.The 3 year disease-free survival (DFS) rate and 5 year overall survival (OS) rate maybe the last evaluation standard.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Capecitabine 1,000 mg/m² twice daily, d1-14, q3w
Oxaliplatin IV infusion, 130mg/m² d1, q3w
D2 resection
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
3-year DFS
Time frame: 3 years after surgery
adverse events
Time frame: From date of randomization until the end of the study, assessed up to 5 years
response rate
Time frame: evaluate after the end of neoadjuvant chemotherapy ie within 1 weeks after the neoadjuvant therapy
R0 resection rate
Time frame: after the pathological examination of resected speciments ie within 1 month after the operation
overall survival
Time frame: 5 years after surgery
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