drugset / Trial / NCT02128425
FOLFOXIRI Compared to FOLFOX in First Line Treatment of Metastatic Colorectal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to evaluate if the exposure to all the three active cytotoxic agents (FOLFOXIRI regimen) is superior in terms of progression-free survival to conventional chemotherapy with the FOLFOX regimen as first-line treatment of chemo-naive metastatic colorectal cancer patients. A second primary aim is to evaluate the response rate, safety and tolerability of the chemotherapy of FOLFOXIRI regimen in this patient population. Patients will be randomized to two therapy groups: Experimental arm A: Chemotherapy with FOLFOXIRI Standard arm B: Chemotherapy with FOLFOX
Timeline
- Start
- 2014-04
- Primary completion
- 2017-02
- Completion
- 2018-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 165 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 200 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 3200 mg/m2 | Intravenous |