A Study of the Use of Irreversible Electroporation in Pancreatic Ductal Cancer

Official Title

Irreversible Electroporation for Locally Advanced Pancreatic Ductal Adenocarcinoma (LEAP TRIAL): A Phase I/II Prospective Trial

Summary:

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.

Trial Description

Primary Outcome:

• Adverse event rate
• Overall survival rate

Secondary Outcome:

• Progression-free survival rate
• Overall survival rate of disease
• Progression-free survival rate of disease

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.

View this trial on ClinicalTrials.gov