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

NCT03257150 | Completed

• 1 other identifier: LEAP
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Adverse event rate

  30 days post IRE or index hospitalization

• Overall survival rate

  Date of IRE treatment to the date of death, up to 2 years

Secondary Outcomes (3)

• Progression-free survival rate

  IRE treatment to the date of documented disease progression or death, up to 2 years

• Overall survival rate of disease

  Date of disease diagnosis to date of death, up to 2 years

• Progression-free survival rate of disease

  Date of disease diagnosis to date of death, up to 2 years

Study Arms (1)

Study Treatment

EXPERIMENTAL

Single arm trial of irreversible electroporation using the NanoKnife system for locally advanced pancreatic ductal adenocarcinoma.

Procedure: Irreversible Electroporation; Device: NanoKnife System

Interventions

Irreversible Electroporation PROCEDURE

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.

Study Treatment

NanoKnife System DEVICE

A system consisting of electrode probes connected to a machine. The probes will be surgically placed around the tumor.

Study Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Interventions

Electroporation

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Steven Gallinger, MD

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 22, 2017
• Study Start: September 22, 2017
• Primary Completion: July 14, 2022
• Study Completion: July 14, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)