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A Pilot Study of Pre- and Post-surgery Chemotherapy With mFOLFIRINOX in Localized, Resectable Pancreatic Adenocarcinoma

NCT01660711 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-11-08

Study results available
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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.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

DRUG

5 Fluorouracil

2400 mg/m2 by continuous intravenous infusion over 46 hours

DRUG

Leucovorin

400 mg/m2 by IV infusion over 2 hours

DRUG

Irinotecan

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

DRUG

Oxaliplatin

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

Sponsors & Collaborators

  • University of Chicago

    collaborator OTHER

  • Endeavor Health

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2018-08-22
Completion
2018-08-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01660711 on ClinicalTrials.gov