drugset / Trial / NCT01193452
S-1/Leucovorin (SL) Versus sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This phase II trial on the assumption that S-1 combined with Leucovorin may have better efficacy and safety than simplified 5-FU/LV infusion therapy in elderly patients with advanced colorectal cancer.
Timeline
- Start
- 2010-08
- Primary completion
- 2011-02
- Completion
- 2012-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leucovorin | Small molecule | 25 mg | Oral |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 50 mg | — |
| Subject | S-1 | Small molecule | 60 mg | — |
| Comparator | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |