drugset / Trial / NCT02935764

FOLFIRI Versus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer Patients

NCT02935764 ↗

Phase 3 Unknown 164 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to compare the efficacy and safety of FOLFIRI regimen with irinotecan monodrug in the treatment of advanced colorectal cancer patients in the second-line setting.

Timeline

Start
2016-10
Primary completion
2019-10
Completion
—

Outcome

Missed primary endpoint

paper respectively [hazard ratio (HR) = 1.084, 95% confidence interval (CI) = 0.7911-1.485; p = 0.6094] PMID 35069808 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications