This is a randomized phase II multicenter controlled study of oxaliplatin, calcium folinate, and 5-fluorouracil (mFOLFOX7) as neoadjuvant chemotherapy for resectable advanced gastric cancer. Hypothesis: Neoadjuvant chemotherapy may improve 5 year overall survival compared with the control.
The study hypothesis is that the 5 year survival rate will reach 35% from 25% when neoadjuvant chemotherapy is carried out. With the alpha value to be 0.05 and beta value to be 0.80 as well as 10 percent of patients' lost-of-followup, the sample size will be 263.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
263
oxaliplatin 100mg/m2, CF 400mg/m2, 5-FU 2400 mg/m2 46hr civ
Peking University School of Oncology
Beijing, Beijing Municipality, China
5 year overall survival
Time frame: Jan 2008 to Dec 2012
R0 resection rate
Time frame: Jan 2008 to Dec 2012
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