Status:
COMPLETED
A Study of the Use of Irreversible Electroporation in Pancreatic Ductal Cancer
Lead Sponsor:
University Health Network, Toronto
Conditions:
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- Stage IV (i.e. metastatic) PDAC
- Have a cystic subtype PDAC of the pancreas
- Previous local treatments for locally advanced PDAC including IRE or radiotherapy
- Recent or concurrent cancer, that is distinct from PDAC in primary site/histology, except cervical carcinoma in situ, localized prostate cancer, treated basal cell carcinoma, superficial bladder tumours (Ta, Tis \& T1) and those that can be permitted with sufficient clinical justification confirming patient safety to undergo the procedure per Principle Investigator and is in the best interest of the patient. 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 locally advanced 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 (including, but not limited to: congestive heart failure, active coronary artery disease, uncontrolled hypertension)
- 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 (e.g.: infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.)
- History of human immunodeficiency virus (HIV) infection
- Progression of the primary lesion as judged by the Investigator
- Working knowledge of English is a must 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.
Key Trial Info
Start Date :
September 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03257150
Start Date
September 22 2017
End Date
July 14 2022
Last Update
August 11 2022
Active Locations (1)
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1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9