Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

University of Louisville (UOFL)

Status and phase

Enrolling

Phase 1

Conditions

Pancreas Cancer

Treatments

Drug: Gemcitabine

Drug: FOLFIRINOX

Procedure: Irreversible Electroporation (IRE)

Study type

Interventional

Funder types

Other

Identifiers

NCT03484299

17.0529

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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