drugset / Trial / NCT02128425

FOLFOXIRI Compared to FOLFOX in First Line Treatment of Metastatic Colorectal Cancer

NCT02128425 ↗

Phase 2 Unknown 162 enrolled Sun Yat-sen University
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

EvaluationDrugModalityDoseRoute
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

Indications