drugset / Trial / NCT01283217
Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer
RandomizedFactorialOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2010-03
- Primary completion
- 2016-03
- Completion
- 2016-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cisplatin | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 35 mg/m2 | Intravenous |
| Background | S-1 | Small molecule | 70 mg/m2 | Oral |