Peri-operative treatment of locally advanced gastric cancer (LAGC) has always been argued by eastern and western scholars. For patients with clinical stage of cT4b/N+M0, or cT4aN+M0, the prognosis is rather poor, and the primary lesions might not be resectable at the time of diagnosis. MAGIC study has showed that pre-and post-operative chemotherapy with 3 cycles of ECF has increased 13% on 5yOS compared with surgery alone; However, eastern studies such as ACTS GC or CLASSIC showed that TS-1 monotherapy or XELOX (oxaliplatin/capecitabine) combination given as adjuvant chemotherapy for stage II or III patients after D2 surgery could achieve the significant survival benefit. So whether perioperative or post operative therapy is more beneficial for LAGC patients lacks of data supported by prospective study. So in this prospective randomized phase III study, the investigators aim to compare the survival benefit as well as the safety for SOX (oxaliplatin/TS-1) as perioperative therapy versus SOX or XELOX as postoperative therapy after D2 dissection.
detailed discription of protocol updated on Feb 2013; detailed discription of protocol updated on Apr 2013; detailed discription of protocol updated on Oct 2013;
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,094
capecitabine:1000 mg/m2 ,bid, d1\~14 oxaliplatin:130mg/m2,iv drip for 2h,d1
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 (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 monotherapy as the same dose and schedule of the above
Lin Shen
Beijing, China
Peking Unicersity Cancer Hospital
Beijing, China
3 year Disease Free Survival
1. perioperative chemotherapy of SOX is superior than postoperative SOX after D2 dissection in LAGC. 2. Postoperative SOX is non inferior to XELOX.
Time frame: 3 years
5 year Overall Survival
1. perioperative chemotherapy of SOX is superior than postoperative SOX after D2 dissection in LAGC. 2. Postoperative SOX is non inferior to XELOX.
Time frame: 5 years
Adverse Event
peri-operation morbidity, mortality, and other adverse events including chemotherapy related ones.
Time frame: 1year
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