RecruitingPhase 1NCT03484299

Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma


Sponsor

University of Louisville

Enrollment

20 participants

Start Date

May 30, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of chemotherapy followed by a procedure called irreversible electroporation (IRE, also known as NanoKnife) — which uses electrical pulses to destroy cancer cells without heat — in patients with Stage III pancreatic cancer that has not yet spread to distant organs. **You may be eligible if...** - You are 18 or older - You have been diagnosed with Stage III pancreatic cancer (locally advanced, meaning it has grown into nearby blood vessels but has not spread to other organs) - Your tumor is measurable on imaging - Your kidney function is adequate - You have recovered well from any prior surgery **You may NOT be eligible if...** - You are currently enrolled in another cancer treatment clinical trial - You are pregnant or breastfeeding - You have a cardiac pacemaker or implantable cardioverter-defibrillator (ICD) that cannot be turned off during the IRE procedure - You have non-removable metal implants within 1 cm of the tumor - You had a heart attack within the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIrreversible Electroporation (IRE)

Non-thermal ablation of tumor

DRUGGemcitabine

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

DRUGFOLFIRINOX

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


Locations(1)

University of Louisville

Louisville, Kentucky, United States

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NCT03484299


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