drugset / Trial / NCT05316818
Triplet (FOLFOXIRI) vs. Doublet (FOLFOX or FOLFIRI) Regimen as a 1st Line Treatment in Metastatic Colorectal Carcinoma
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a prospective randomized phase II trial was done in clinical oncology department at Kasr Alainy hospital, Cairo university (NEMROCK) to evaluate the role of intensification of chemotherapy in the first line for treatment of metastatic colorectal carcinoma by adding third agent to standard doublet regimen on oncological outcomes \& assess tolerance to the intensified treatment
Timeline
- Start
- 2018-01-16
- Primary completion
- 2020-12-01
- Completion
- 2021-04-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 160 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 600 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |