Pancreas Cancer
Conditions
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.
Interventions
PROCEDUREIrreversible Electroporation (IRE)
Non-thermal ablation of tumor
DRUGGemcitabine
25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
DRUGFOLFIRINOX
25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
Sponsors
University of Louisville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects undergoing IRE will receive treatment with either FOLFIRINOX or gemcitabine (based on which regimen was received prior to IRE)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability) | Time from first dose until subject has reached 90 days post last active study treatment | Adverse and Serious Adverse events will be collected and analyzed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | Time from first dose date to first date of confirmed disease progression, assessed for 90 days | 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. |
Countries
United States
Contacts
Primary ContactRobert Martin, MD, PhD
Outcome results
None listed