drugset / Trial / NCT00721916
Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, multicenter study designed to evaluate the progression free survival of the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV and Oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.
Timeline
- Start
- 2008-07
- Primary completion
- 2012-03
- Completion
- 2012-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leucovorin | Small molecule | 25 mg | Intravenous |
| Subject | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Subject | S-1 | Small molecule | 40 mg | — |
| Subject | S-1 | Small molecule | 60 mg | — |
| Comparator | fluorouracil | Small molecule | 400 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |