CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
FOLFIRINOXdrug
Likely dose
FOLFIRINOX 85 mg/m2from 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/NCT02178709
NCT02178709Phase 2Completed
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A Phase II Study of Neoadjuvant FOLFIRINOX in Patients With Resectable Pancreatic Ductal Adenocarcinoma With Tissue Collection

Indiana University·interventional·Posted Jul 1, 2014·Updated Apr 19, 2022

In Brief

A Phase 2 clinical trial evaluating FOLFIRINOX for Resectable Pancreatic Ductal Adenocarcinoma. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The primary objective of this study is to evaluate the rate of pathologic complete response to neoadjuvant FOLFIRINOX in patients with resectable pancreatic cancer using a tissue collection component.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsResectable Pancreatic Ductal Adenocarcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 1, 2014
Enrollment StartJun 3, 2014
Primary CompletionFeb 14, 2018
Study CompletionOct 28, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 12.0 years ago

Interventions

FOLFIRINOXdrug

FOLFIRINOX consists of the following combination of drugs: 1. Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle 2. Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle 3. Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle 4.5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle. 5.5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle.