<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03257150</url>
  </required_header>
  <id_info>
    <org_study_id>LEAP</org_study_id>
    <nct_id>NCT03257150</nct_id>
  </id_info>
  <brief_title>A Study of the Use of Irreversible Electroporation in Pancreatic Ductal Cancer</brief_title>
  <official_title>Irreversible Electroporation for Locally Advanced Pancreatic Ductal Adenocarcinoma (LEAP TRIAL): A Phase I/II Prospective Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This I/II study will evaluate to see how safe and useful irreversible electroporation (also&#xD;
      called NanoKnife) is in patients with locally advanced pancreatic cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this phase I/II trial, patients with locally advanced pancreatic ductal carcinoma will be&#xD;
      assigned to receive interventional treatment of irreversible electroporation (IRE).&#xD;
&#xD;
      IRE will be performed by laparotomy under general anesthesia in the operating room.&#xD;
&#xD;
      All patients enrolled in the study will have a biopsy at the time of laparotomy. Blood will&#xD;
      be collected for regular blood tests and correlative studies at baseline and during the&#xD;
      study. Computed tomography (CT) scans will be done at baseline, 4 weeks post treatment, 12&#xD;
      weeks, 24 weeks, and 36 weeks follow up. Quality of Life (QOL) questionnaires will be&#xD;
      completed at baseline and during the study. Patients will be given optional consent for&#xD;
      storage of any leftover tissue and blood samples for future analysis. Patients will be&#xD;
      followed up 4 weeks post treatment, then every 12 weeks until death.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Actual">July 14, 2022</completion_date>
  <primary_completion_date type="Actual">July 14, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse event rate</measure>
    <time_frame>30 days post IRE or index hospitalization</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival rate</measure>
    <time_frame>Date of IRE treatment to the date of death, up to 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival rate</measure>
    <time_frame>IRE treatment to the date of documented disease progression or death, up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival rate of disease</measure>
    <time_frame>Date of disease diagnosis to date of death, up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival rate of disease</measure>
    <time_frame>Date of disease diagnosis to date of death, up to 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Pancreatic Ductal Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Study Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm trial of irreversible electroporation using the NanoKnife system for locally advanced pancreatic ductal adenocarcinoma.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Irreversible Electroporation</intervention_name>
    <description>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.</description>
    <arm_group_label>Study Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NanoKnife System</intervention_name>
    <description>A system consisting of electrode probes connected to a machine. The probes will be surgically placed around the tumor.</description>
    <arm_group_label>Study Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven pancreatic ductal adenocarcinoma (PDAC)&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Locally advanced unresectable primary tumor&#xD;
&#xD;
          -  Tumors ≤5 cm in largest dimension at the time of enrollment that is technically&#xD;
             amenable to treatment with irreversible electroporation (IRE)&#xD;
&#xD;
          -  At least 4 months of combination chemotherapy&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2&#xD;
&#xD;
          -  Acceptable organ and bone marrow function&#xD;
&#xD;
          -  Life expectancy estimated ≥6 months&#xD;
&#xD;
          -  Ability and willingness to sign informed consent form&#xD;
&#xD;
          -  Have a measurable primary tumor at the time of study enrollment&#xD;
&#xD;
          -  Suitable and fit to undergo general anesthetic and laparotomy&#xD;
&#xD;
          -  Women of child-producing potential must agree to use effective contraceptive methods&#xD;
             prior to study entry, during study participation, and for at least 30 days after the&#xD;
             last administration of study medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stage IV (i.e. metastatic) PDAC&#xD;
&#xD;
          -  Have a cystic subtype PDAC of the pancreas&#xD;
&#xD;
          -  Previous local treatments for locally advanced PDAC including IRE or radiotherapy&#xD;
&#xD;
          -  Recent or concurrent cancer, that is distinct from PDAC in primary site/histology,&#xD;
             except cervical carcinoma in situ, localized prostate cancer, treated basal cell&#xD;
             carcinoma, superficial bladder tumours (Ta, Tis &amp; T1) and those that can be permitted&#xD;
             with sufficient clinical justification confirming patient safety to undergo the&#xD;
             procedure per Principle Investigator and is in the best interest of the patient.&#xD;
             Cancer curatively treated ≥3 years prior to entry is permitted.&#xD;
&#xD;
          -  Prior chemotherapy within 3 years of diagnosis of PDAC. Chemotherapy for PDAC is&#xD;
             permitted&#xD;
&#xD;
          -  Direct invasion of locally advanced PDAC into the stomach or duodenum&#xD;
&#xD;
          -  Metallic biliary stent that cannot be substituted with a plastic stent&#xD;
&#xD;
          -  Allergy to computed tomography (CT) or magnetic resonance imaging (MRI) contrast that&#xD;
             cannot be safely managed with premedication which preclude assessment and/or&#xD;
             surveillance of PDAC&#xD;
&#xD;
          -  History of cardiac disease (including, but not limited to: congestive heart failure,&#xD;
             active coronary artery disease, uncontrolled hypertension)&#xD;
&#xD;
          -  Any active major medical illnesses of the respiratory or immune system, or other&#xD;
             conditions that may affect patient's ability to tolerate general anesthesia and IRE&#xD;
             therapy on this trial&#xD;
&#xD;
          -  History of solid organ transplantation or collagen vascular disease&#xD;
&#xD;
          -  Medical, psychological or social conditions that may interfere with the patient's&#xD;
             participation in the study or evaluation of the study results&#xD;
&#xD;
          -  Pregnant or breast feeding women&#xD;
&#xD;
          -  Pre-menopausal women unwilling to take a pregnancy test&#xD;
&#xD;
          -  Any other condition that would, in the Investigator's judgment, contraindicate the&#xD;
             patient's participation in the clinical study due to safety concerns or compliance&#xD;
             with clinical study procedures (e.g.: infection/inflammation, intestinal obstruction,&#xD;
             unable to swallow medication, social/ psychological issues, etc.)&#xD;
&#xD;
          -  History of human immunodeficiency virus (HIV) infection&#xD;
&#xD;
          -  Progression of the primary lesion as judged by the Investigator&#xD;
&#xD;
          -  Working knowledge of English is a must in order to complete the quality of life&#xD;
             questionnaires being administered in this study. Patients who do not meet this&#xD;
             requirement will be exempt from the quality of life assessments but remain eligible&#xD;
             for all other components of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Gallinger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Princess Margaret Cancer Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 10, 2022</last_update_submitted>
  <last_update_submitted_qc>August 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03257150
org study id: LEAP
nct id: NCT03257150
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse event rate
time frame: 30 days post IRE or index hospitalization
measure: Overall survival rate
time frame: Date of IRE treatment to the date of death, up to 2 years
measure: Progression-free survival rate
time frame: IRE treatment to the date of documented disease progression or death, up to 2 years
measure: Overall survival rate of disease
time frame: Date of disease diagnosis to date of death, up to 2 years
measure: Progression-free survival rate of disease
time frame: Date of disease diagnosis to date of death, up to 2 years
arm group label: Study Treatment
arm group type: Experimental
description: Single arm trial of irreversible electroporation using the NanoKnife system for locally advanced pancreatic ductal adenocarcinoma.
intervention type: Procedure
intervention name: Irreversible Electroporation
description: 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.
arm group label: Study Treatment
intervention type: Device
intervention name: NanoKnife System
description: A system consisting of electrode probes connected to a machine. The probes will be surgically placed around the tumor.
arm group label: Study Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven Gallinger, MD
role: Principal Investigator
affiliation: Princess Margaret Cancer Centre
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Adenocarcinoma
sharing ipd: No