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

August 10, 2022 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study Treatment
Single arm trial of irreversible electroporation using the NanoKnife system for locally advanced pancreatic ductal adenocarcinoma.
Procedure: Irreversible Electroporation
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.
Device: NanoKnife System
A system consisting of electrode probes connected to a machine. The probes will be surgically placed around the tumor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse event rate
Time Frame: 30 days post IRE or index hospitalization
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
Date of IRE treatment to the date of death, up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival rate
Time Frame: IRE treatment to the date of documented disease progression or death, up to 2 years
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
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
Date of disease diagnosis to date of death, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Steven Gallinger, MD, Princess Margaret Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 22, 2017

Primary Completion (ACTUAL)

July 14, 2022

Study Completion (ACTUAL)

July 14, 2022

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (ACTUAL)

August 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 10, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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