Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Summary

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

Interventions

• Irreversible Electroporation (IRE) · PROCEDURE

  Non-thermal ablation of tumor

• Gemcitabine · DRUG

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

• FOLFIRINOX · DRUG

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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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 (1)

• University of Louisville, Louisville, Kentucky · RECRUITING