Gastric Cancer Clinical Trial
Official title:
A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer
Background: It is shown that TS-1 as adjuvant chemotherapy after D2 resection in patients
with gastric cancer can improve DFS and OS in one Japanese Trial. And TS-1 has become one of
the standard therapies to these patients. But it is still unknown whether it would improve
more to OS and DFS than single TS-1 after combined with oxaliplatin . This trial is designed
to investigate the efficacy and safety of TS-1 plus oxaliplatin versus TS-1 single as
adjuvant chemotherapy after D2 resection in patients with gastric cancer.
Patients and methods: In this study , patients with histologically confirmed gastric cancer
who received D2 resection and staged II or III, aged from 18 to 70 years and with Eastern
Cooperative Oncology Group performance status ā‰¤2 and adequate organ function, are randomized
1:1 to oxaliplatin 100mg/m2 on day 1 and TS-1 40~60mg twice everyday for 14 days in a
21-days cycle for total 6 cycles followed by TS-1 single with the same dose and frequency to
the end of the 1st year postoperatively(SOX) , or TS-1 single 40~60mg twice everyday for 14
days in a 21-days cycle to the end of the 1st year postoperatively (TS-1). The primary end
point is overall survival (OS), and secondary end point is disease free survival(DFS) and
safety. Final study analysis will be conducted in the end of the 5th year after the last
patient's enrollment.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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