Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Multicenter, Open-label, Phase III Trial of Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected (D2) Gastric Cancer of Stage IIIB/IV (M0)|
- 3-year disease free survival(DFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]Tumor assessments with chest X-rays and CT or MRI scan will be done at 6 months after randomization (after the end of the treatment period), then every 3 months for the first 2 years after randomization and then every 6 months for coming 3 years then one year basis until completion of the study.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: DS(Docetaxel with S-1)
Docetaxel with S-1
Docetaxel with S-1. S-1: Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.
Active Comparator: SP(S-1 with cisplatin)
S-1 with cisplatin
S-1 with cisplatin. S-1 : Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.
|Korea, Republic of|
|Seoul, Korea, Republic of, 120-752|
|Contact: Sun-Young Rha, MD, Ph.D 82-2-2228-8050 firstname.lastname@example.org|