drugset / Trial / NCT00811447
Taxotere New Indication - Gastric Cancer Treatment Registration Trial
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary objective: To detect a statistically significant increase in time to progression (TTP) of disease for the test group (Taxotere® \[Docetaxel\] combined with cisplatin and 5-fluorouracil \[TCF\]) relative to the control group (Cisplatin combined with 5-fluorouracil\[CF\]) Secondary objectives: * To detect a statistically significant increase in overall survival (OS) for the test group relative to the control group. * To compare response rate (RR), time to treatment failure (TTF), duration of responses, safety profiles, quality of life (QOL), and disease-related symptoms.
Timeline
- Start
- 2008-11
- Primary completion
- 2012-06
- Completion
- 2012-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 60 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 600 mg/m2 | Intravenous |