Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|