drugset / Trial / NCT00602745
S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.
Timeline
- Start
- 2008-02
- Primary completion
- 2010-03
- Completion
- 2010-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | S-1 | Small molecule | — | Oral |
| Comparator | fluorouracil | Small molecule | — | Intravenous |