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NCT03484299PHASE1Recruiting

Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

University of Louisville

Start Date

5/30/2018

Completion Date

7/31/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

PROCEDURE

Irreversible Electroporation (IRE)

DRUG

Gemcitabine

DRUG

FOLFIRINOX

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Conditions

Pancreas Cancer

Locations

University of Louisville

Louisville, Kentucky 40202

United States