Trial intelligence / Profile preview

POST: Docetaxel and S-1 vs S-1 and Cisplatin in Stage III Gastric Cancer

NCT01283217Phase 3

Key facts

Status
Unknown
Start
Mar 2010
Primary completion
Mar 2016
Countries
1
Sponsor
Yonsei University
Modality
Small Molecules
Conditions
gastric adenocarcinoma
01

Overview

Phase 3, randomised, open-label trial of docetaxel in gastric adenocarcinoma, sponsored by Yonsei University. Status: unknown.

02

Design

Study design
RandomizedOpen-label
03

Registry description

Docetaxel was the first drug that showed survival benefits when added to the CF regimen, but it was very toxic. Docetaxel is also has a synergistic anti-cancer effect with S-1, in phase I/II studies. The use of a docetaxel plus S-1 combination as first-line chemotherapy for advanced gastric cancer achieved response rates of 46\~56% and a median survival time of 14.0\~14.3 months.

Based upon this background, the aim of this study is to detect a significant increase in 3 year DFS of disease for the test group (DS) relative to the Control group (SP).

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