drugset / Trial / NCT00587145
Phase II Study of Perioperative S-1 Plus Docetaxel in Patients With Localized Advanced Gastric Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study is an open-label, single center, and a single arm phase II study to evaluate the clinical response and safety of perioperative S-1 plus docetaxel. Perioperative chemotherapy is composed of 3 cycles of preoperative S-1/docetaxel and 3 cycles of postoperative S-1/docetaxel.Chemotherapy regimen: * S-1 80 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning) * Docetaxel 35 mg/m2 mixed in d5w 250 ml iv over 60-min on days 1 and 8
Timeline
- Start
- 2006-05
- Primary completion
- 2009-03
- Completion
- 2009-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 35 mg/m2 | Intravenous |
| Subject | S-1 | Small molecule | 80 mg/m2 | Oral |