This I/II study will evaluate to see how safe and useful irreversible electroporation (also called NanoKnife) is in patients with locally advanced pancreatic cancer.
In this phase I/II trial, patients with locally advanced pancreatic ductal carcinoma will be assigned to receive interventional treatment of irreversible electroporation (IRE). IRE will be performed by laparotomy under general anesthesia in the operating room. All patients enrolled in the study will have a biopsy at the time of laparotomy. Blood will be collected for regular blood tests and correlative studies at baseline and during the study. Computed tomography (CT) scans will be done at baseline, 4 weeks post treatment, 12 weeks, 24 weeks, and 36 weeks follow up. Quality of Life (QOL) questionnaires will be completed at baseline and during the study. Patients will be given optional consent for storage of any leftover tissue and blood samples for future analysis. Patients will be followed up 4 weeks post treatment, then every 12 weeks until death.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Irreversible electroporation (IRE) is a process that uses the NanoKnife system to sent electrical currents to a cancer tumor which will disrupt the tumor cell and therefore causing the cell to die. Eligible patients will undergo in situ IRE performed via laparotomy surgery.
A system consisting of electrode probes connected to a machine. The probes will be surgically placed around the tumor.
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Adverse event rate
Time frame: 30 days post IRE or index hospitalization
Overall survival rate
Time frame: Date of IRE treatment to the date of death, up to 2 years
Progression-free survival rate
Time frame: IRE treatment to the date of documented disease progression or death, up to 2 years
Overall survival rate of disease
Time frame: Date of disease diagnosis to date of death, up to 2 years
Progression-free survival rate of disease
Time frame: Date of disease diagnosis to date of death, up to 2 years
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