Department of General Surgery
Shijiazhuang, Hebei, 050011, China
NCT Number: NCT01516944
Stage I:Neoadjuvant therapy
* Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to surgery alone;Capecitabine plus oxaliplatin is non-inferiority to Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin
Stage II: Perioperative therapy
* Perioperative Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to adjuvant Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin alone;Capecitabine plus oxaliplatin regimen is noninferiority to Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin * A regimen of Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin(SOX) and Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic gastric cancer. The investigators assessed whether the addition of a perioperative regimen of SOX or XELOX regimen to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced gastric cancer.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 2 / Phase 3
Shijiazhuang, Hebei, 050011, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 1.2 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);
Tegafur,Gimeracil and Oteracil Potassium Capsules 80 mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation
Other names: S-1, Oxaliplatin
Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycle pre-operation, Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/m2 D1 q3wk for six cycles postoperation
Other names: Oxaliplatin, Capecitabine
Time frame: 3 year
Time frame: At the end of the study
Time frame: At the end of the study
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
Time frame: Within 3 weeks after surgery
After the pathological examination of resected specimen
Time frame: 5 year
Time frame: Side effects during observation
Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit.
Time frame: Within 3 weeks after surgery
After the pathological examination of resected specimen
Hebei Medical University
Other
Perioperative Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin Versus Capecitabine Plus Oxaliplatin in Patients With Localized Advanced Gastric Cancer
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