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Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Primary Purpose

Pancreas Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Irreversible Electroporation (IRE)
Gemcitabine
FOLFIRINOX
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of LouisvilleRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)
Adverse and Serious Adverse events will be collected and analyzed

Secondary Outcome Measures

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.

Full Information

First Posted
February 13, 2018
Last Updated
May 8, 2023
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT03484299
Brief Title
Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Official Title
Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
All subjects undergoing IRE will receive treatment with either FOLFIRINOX or gemcitabine (based on which regimen was received prior to IRE)
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm Description
Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)
Intervention Type
Procedure
Intervention Name(s)
Irreversible Electroporation (IRE)
Intervention Description
Non-thermal ablation of tumor
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
Intervention Type
Drug
Intervention Name(s)
FOLFIRINOX
Intervention Description
25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
Primary Outcome Measure Information:
Title
Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)
Description
Adverse and Serious Adverse events will be collected and analyzed
Time Frame
Time from first dose until subject has reached 90 days post last active study treatment
Secondary Outcome Measure Information:
Title
Progression free survival
Description
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 Frame
Time from first dose date to first date of confirmed disease progression, assessed for 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Traci Hayat, RN
Phone
502-629-3383
Email
traci.hayat@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Martin, MD, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Traci Hayat, RN
Phone
502-629-3383
Email
traci.hayat@louisville.edu
First Name & Middle Initial & Last Name & Degree
Robert Martin, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32681477
Citation
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.
Results Reference
derived

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Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

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