Chemotherapy And Irreversible Electroporation In The Treatment Of Advanced Pancreatic Adenocarcinoma

Study Overview

Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.

Phase II study in which all patients undergoing IRE for the treatment of locally advanced pancreatic carcinoma will receive either FOLFIRINOX or gemcitabine as peri-ablation treatment.

Pancreas Cancer

PROCEDURE: Irreversible Electroporation (IRE)
DRUG: Gemcitabine
DRUG: FOLFIRINOX

17.0529

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-02-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-24
First Submitted that Met QC Criteria 2018-03-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-27
First Posted (ACTUAL) 2018-03-30	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: Treatment Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)	PROCEDURE: Irreversible Electroporation (IRE) Non-thermal ablation of tumor DRUG: Gemcitabine 25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled DRUG: FOLFIRINOX 25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled

Participant Group/Arm

Intervention/Treatment

OTHER: Treatment

Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)

PROCEDURE: Irreversible Electroporation (IRE)

Non-thermal ablation of tumor

DRUG: Gemcitabine

25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled

DRUG: FOLFIRINOX

25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled

Primary Outcome Measures	Measure Description	Time Frame
Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)	Adverse and Serious Adverse events will be collected and analyzed	Time from first dose until subject has reached 90 days post last active study treatment

Secondary Outcome Measures	Measure Description	Time Frame
Progression free survival	Triphase CT scan will be performed within one month of IRE procedure. Triphase CT scans will then be obtained every 3 months to check disease status.	Time from first dose date to first date of confirmed disease progression, assessed for 90 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Traci Hayat, RN

Phone Number: 502-629-3383

Email: traci.hayat@louisville.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

greater than or equal to 18 years of age
diagnosed with stage III pancreatic cancer
tumor is measurable
GFR > mL/min/1.73m2
willing and able to comply with protocol requirements
AST/ALT >3 times upper limit of normal
stable surgical post-operative course as defined by operative surgeon

participating in another clinical trial for the treatment of cancer at the time of screening
pregnant or currently breast feeding
have a cardiac pacemaker or ICD implanted that cannot be deactivated during IRE procedure
have non-removable implants with metal parts within 1 cm of the target lesion
had a myocardial infarction within 3 months prior to enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Robert Martin, MD, PhD, University of Louisville

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Bhutiani N, Li Y, Zheng Q, Pandit H, Shi X, Chen Y, Yu Y, Pulliam ZR, Tan M, Martin RCG 2nd. Electrochemotherapy with Irreversible Electroporation and FOLFIRINOX Improves Survival in Murine Models of Pancreatic Adenocarcinoma. Ann Surg Oncol. 2020 Oct;27(11):4348-4359. doi: 10.1245/s10434-020-08782-2. Epub 2020 Jul 17.

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Resources

Patients

Caregivers

Clinical Trial Record