Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
1 other identifier
interventional
20
1 country
1
Brief Summary
Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2018
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2018
CompletedFirst Posted
Study publicly available on registry
March 30, 2018
CompletedStudy Start
First participant enrolled
May 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
October 29, 2025
October 1, 2025
8.2 years
February 13, 2018
October 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Progression free survival
Time from first dose date to first date of confirmed disease progression, assessed for 90 days
Study Arms (1)
Treatment
OTHERIrreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)
Interventions
25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Louisville
Louisville, Kentucky, 40202, United States
Related Publications (1)
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.
PMID: 32681477DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Martin, MD, PhD
University of Louisville
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 13, 2018
First Posted
March 30, 2018
Study Start
May 30, 2018
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2027
Last Updated
October 29, 2025
Record last verified: 2025-10