Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

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

Detailed Description
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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.

Official Title
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Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma

Conditions
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Pancreas Cancer

Intervention / Treatment
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* Procedure: Irreversible Electroporation (IRE)
* Drug: Gemcitabine
* Drug: FOLFIRINOX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects undergoing IRE will receive treatment with either FOLFIRINOX or gemcitabine (based on which regimen was received prior to IRE)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE) | Procedure: Irreversible Electroporation (IRE)<br>* Non-thermal ablation of tumor<br>Drug: Gemcitabine<br>* 25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled<br>Drug: FOLFIRINOX<br>* 25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability) | Adverse and Serious Adverse events will be collected and analyzed | Time from first dose until subject has reached 90 days post last active study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 from first dose date to first date of confirmed disease progression, assessed for 90 days |