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Clinical Trial Summary

The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tumor in comparison with surgery alone.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00252161
Study type Interventional
Source Japan Clinical Oncology Group
Contact
Status Completed
Phase Phase 3
Start date November 2005
Completion date April 2015

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