Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
ConditionPancreas Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Louisville
About this trial
Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
greater than or equal to 18 years of age
diagnosed with stage III pancreatic cancer
tumor is measurable
GFR > mL/min/1.73m2
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Irreversible Electroporation (IRE)
Procedure/SurgeryNon-thermal ablation of tumor
Gemcitabine
Drug25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
FOLFIRINOX
Drug25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: TreatmentOther 3 interventions
Trial outcomes
Primary outcomes
1
Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)
Adverse and Serious Adverse events will be collected and analyzed
Time frame
Time from first dose until subject has reached 90 days post last active study treatmentSecondary outcomes
1
Progression free survival
Triphase CT scan will be performed within one month of IRE procedure. Triphase CT scans will then be obtained every 3 months to check disease status.
Time frame
Time from first dose date to first date of confirmed disease progression, assessed for 90 daysSponsors and contacts
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Source ClinicalTrials.gov