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
Conditions
Pancreas Cancer
Locations
University of Louisville
Louisville, Kentucky 40202
United States