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

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 47
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Last Updated: 2017-09-27

Criteria

Inclusion Criteria:

• Histologically proven pancreatic ductal adenocarcinoma (PDAC)

• Age ≥ 18 years

• Locally advanced unresectable primary tumor

• Tumors ≤5 cm in largest dimension at the time of enrollment that is technically amenable to treatment with irreversible electroporation (IRE)

• At least 4 months of combination chemotherapy

• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

• Acceptable organ and bone marrow function

• Life expectancy estimated ≥6 months

• Ability and willingness to sign informed consent form

• Have a measurable primary tumor at the time of study enrollment

• Suitable and fit to undergo general anesthetic and laparotomy

• Women of child-producing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication.

Exclusion Criteria:

• Stage IV (i.e. metastatic) PDAC

• Has a cystic subtype of PDAC

• Previous local treatments for locally advanced PDAC including IRE or radiotherapy

• Recent or concurrent cancer, that is distinct from PDAC in primary site/histology. Cancer curatively treated ≥3 years prior to entry is permitted

• Prior chemotherapy within 3 years of diagnosis of PDAC. Chemotherapy for PDAC is permitted

• Direct invasion of PDAC into the stomach or duodenum

• Metallic biliary stent that cannot be substituted with a plastic stent

• Allergy to computed tomography (CT) or magnetic resonance imaging (MRI) contrast that cannot be safely managed with premedication which preclude assessment and/or surveillance of PDAC

• History of cardiac disease

• Any active major medical illnesses of the respiratory or immune system, or other conditions that may affect patient's ability to tolerate general anesthesia and IRE therapy on this trial

• History of solid organ transplantation or collagen vascular disease

• Medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

• Pregnant or breast feeding women

• Pre-menopausal women unwilling to take a pregnancy test

• Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures

• History of human immunodeficiency virus (HIV) infection

• Have a working knowledge of English in order to complete the quality of life questionnaires being administered in this study. Patients who do not meet this requirement will be exempt from the quality of life assessments but remain eligible for all other components of the study.