Randomized Phase III Trial of Surgery Plus Neoadjuvant TS-1 and Cisplatin Compared With Surgery Alone for Type 4 and Large Type 3 Gastric Cancer: Japan Clinical Oncology Group Study (JCOG 0501)
A randomized phase III study is going to started in Japan to compare TS-1 plus cisplatin as
a neoadjuvant chemotherapy with surgery alone in patient with type 4 and large type 3
gastric cancer.A total of 300 patients will be accrued for this study from 35 institutions
within five years. The primary endpoint is overall survival. The secondary endpoints are
progression free survival (PFS), response rate, proportion of protocol achievement,
proportion of curative resection, and adverse events.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival
during the study conduct
No
Mitsuru Sasako, MD, PhD
Study Chair
Hyogo College of Medicine
Japan: Ministry of Health, Labor and Welfare
JCOG0501
NCT00252161
November 2005
April 2015
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