CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
5 Fluorouracil +3 moredrug
Likely dose
5 Fluorouracil 2400 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/NCT01660711
NCT01660711Phase 2Completed
CompareCT.gov

A Pilot Study of Neoadjuvant and Adjuvant mFOLFIRINOX in Localized, Resectable Pancreatic Adenocarcinoma

Endeavor Health·interventional·Posted Aug 9, 2012·Updated Nov 8, 2021

In Brief

A Phase 2 clinical trial evaluating 5 Fluorouracil, Leucovorin, and 2 other interventions for Pancreatic Adenocarcinoma. Completed, enrolled 22 participants across 1 site.

Detailed Summary

The purpose of the study is to demonstrate that it is possible to administer chemotherapy prior to and following surgery for pancreatic cancer which is considered operable. The chemotherapy chosen is that which has been shown to be the most effective in treating metastatic disease, and the goal is both to investigate whether this is tolerable and also to investigate the efficacy of this approach in terms of disease response and survival.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Adenocarcinoma
CountriesUnited States
CollaboratorsUniversity of Chicago

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 9, 2012
Enrollment StartJul 1, 2012
Primary CompletionAug 22, 2018
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 13.9 years ago

Interventions

5 Fluorouracildrug

2400 mg/m2 by continuous intravenous infusion over 46 hours

Leucovorindrug

400 mg/m2 by IV infusion over 2 hours

Irinotecandrug

180 mg/m² IV infusion on Day 1 over 90-120 minutes (infusion via a Y connector during the infusion of leucovorin)

Oxaliplatindrug

85 mg/m² IV infusion on Day 1 over 2 hours