Status:
RECRUITING
Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Lead Sponsor:
University of Louisville
Conditions:
Pancreas Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03484299
Start Date
May 30 2018
End Date
July 31 2027
Last Update
October 29 2025
Active Locations (1)
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1
University of Louisville
Louisville, Kentucky, United States, 40202