Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Recruiting · NCT03484299 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Louisville
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- University of Louisville - Louisville, Kentucky, United States