CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 244 enrolled
Drug / intervention
FOLFIRI +1 moredrug
Likely dose
FOLFIRI 180 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01219920
NCT01219920Phase 3Completed
CompareCT.gov

Phase III Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFOXIRI) Compared With Infusional Fluorouracil, Leucovorin and Irinotecan (FOLFIRI) as First-line Treatment for Metastatic Colorectal Cancer

Gruppo Oncologico del Nord-Ovest·interventional·Posted Oct 13, 2010·Updated Mar 11, 2015

In Brief

A Phase 3 clinical trial evaluating FOLFIRI and FOLFOXIRI for Metastatic Colorectal Cancer. Completed, enrolled 244 participants across 48 sites.

Detailed 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 response rate to conventional chemotherapy with the FOLFIRI regimen as first-line treatment of metastatic colorectal cancer patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 13, 2010
Enrollment StartNov 1, 2001
Primary CompletionNov 1, 2005
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 15.7 years ago

Interventions

FOLFIRIdrug

Irinotecan 180 mg/sqm on day 1 Leucovorin 100 mg/sqm on day 1 and day 2 5-fluorouracil 400 mg/sqm bolus followed by 5-fluorouracil 600 mg/sqm 22-hour continuous infusion on day 1 and day 2 Repeated every 2 weeks

FOLFOXIRIdrug

Irinotecan 165 mg/sqm on day 1 Oxaliplatin 85 mg/sqm on day 1 Leucovorin 200 mg/sqm on day 1 5-fluorouracil 3200 mg/sqm 48-hour continuous infusion starting on day 1 Repeated every 2 weeks