Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer
|ClinicalTrials.gov Identifier: NCT01283217|
Recruitment Status : Unknown
Verified June 2013 by Yonsei University.
Recruitment status was: Recruiting
First Posted : January 25, 2011
Last Update Posted : June 4, 2013
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).
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma||Drug: DS Drug: SP||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||166 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2016|
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.
- 3-year disease free survival(DFS) [ Time Frame: 3 years ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283217
|Korea, Republic of|
|Seoul, Korea, Republic of, 120-752|
|Contact: Sun-Young Rha, MD, Ph.D 82-2-2228-8050 email@example.com|