This is a randomized, multicenter, controlled trial to prove efficacy of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients who undergo D2 gastrectomy. The primary endpoint is three-year free disease and the second primary includes five-year overall survival, safety and R0 resection rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
772
S-1: 40\~60mg bid,po, d1\~14 (S-1:BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid) oxaliplatin:130mg/m2,iv drip for 2h,d1
S-1:40\~60mg bid,d1\~14 q3W oxaliplatin:130mg/m2,iv drip for 2h,d1,q3W 8 cycles (6 months)
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGdisease free survival
SOX regimen as Neoadjuvant chemotherapy for AJCC II-III gastric cancer patients is superior than postoperative SOX after D2 surgery.Disease free survival is defined as time of surgery to recurrence or death.
Time frame: three years
response rate
For neoadjuvant chemotherapy patients,response rate will be evaluated according to RECIST 1.1 criteria after at least 2 cycles of SOX chemotherapy.CT scan is required to every patient.
Time frame: 3 months
overall survival
Neoadjuvant chemotherapy of SOX is superior than postoperative SOX after D2 dissection in AJCC II-III gastric cancer patients.Overall survival is defined as the time of randomization to death.
Time frame: five years
safety
Number of participants with adverse events related to SOX chemotherapy.All adverse events are from CTCAE 4.0 criteria.
Time frame: six months
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