Phase I/II Study of Oral S-1 Plus f Oxaliplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer
This stage I/II study is designed to evaluate the appropriate dose of S-1 plus fixed-dose of
oxaliplatin (SOX regimen) for Patients with D2 resection of gastric cancer and survival of
SOX regimen for stage II-III patients(AJCC 7th). To assess the efficacy, data on recurrence
and survival will be collected from the time of enrollment until 3 years after surgery. To
evaluate safety, data on adverse events will be collected from the time of enrollment until
1 year after surgery.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
3 year recurrence-free survival(RFS)
from the date of surgery until the occurrence of an event (relapse or death whichever came first)
3 years
No
Lin Yang, MD
Principal Investigator
Department of Medical Oncology,Cancer Hospital and Institute,CAMS
China: Food and Drug Administration
CH-GI-020
NCT01542294
June 2011
May 2017
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