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A Clinical Research About Using Irreversible Electroporation to Treat Locally Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Irreversible Electroporation (IRE) System
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring irreversible electroporation, pancreatic cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for this study:

  1. Locally advanced pancreatic cancer is defined as per the 7th edition of the American Joint Committee on Cancer (AJCC) staging system for pancreatic cancer -described as arterial encasement of either the celiac axis or superior mesenteric artery or both.
  2. Biliary tract or intestine is compromised by tumor, palliative bypass operation (hepaticojejunostomy and/or gastrojejunostomy) is considered to be performed.
  3. Eastern Cooperative Oncology Group (ECOG) score of 0-1,
  4. American Society of Anaesthesiologists (ASA) score ≤ 3,
  5. Adequate bone marrow, liver and renal function. Platelet count ≥ 100 K/Μl. Total bilirubin ≦ 5 mg/dL. alanine transaminase (ALT) and aspartate transaminase (AST) < 5 x upper limit of normal. prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0 (5). Serum creatinine ≦ 1.5 x upper limit of normal
  6. Prior Informed Consent Form
  7. Life expectancy of at least 3 months.

Exclusion Criteria:

Patients presenting with any of the following will not be enrolled into this study:

  1. History of cardiac disease:
  2. Congestive heart failure >New York Heart Association (NYHA) class 2
  3. Active coronary artery disease (CAD) (myocardial infarction more than 6 months prior to study entry is allowed)
  4. Cardiac arrhythmias (>Grade 2 NCI-CTCAE Version 3.0) which are poorly controlled with anti-arrhythmic therapy or requiring pace maker
  5. Uncontrolled hypertension
  6. Any active metal implanted device (eg Pacemaker),
  7. Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
  8. Received treatment with an investigational agent/ procedure within 30 days prior to treatment with the IRE System,
  9. Known history of human immunodeficiency virus (HIV) infection
  10. Patients with resectable lesions.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    irreversible electroporation (IRE)

    Arm Description

    IRE (AngioDynamics, NY) To use 2 to 6 unipolar electrodes in a predetermined grid pattern. 90 pulses of 2,000 - 3,000 V were applied with a pulse generator (AngioDynamics, NY) across the gap between the electrodes for 100 microseconds (0.1 msec) per each ablation.

    Outcomes

    Primary Outcome Measures

    Tumor response
    Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI).

    Secondary Outcome Measures

    Eastern Cooperative Oncology Group (ECOG) evaluation
    Complete an Eastern Cooperative Oncology Group (ECOG) evaluation
    Haematology test
    complete white blood cell count with differential, red blood cell count, hemoglobin, hematocrit, and platelets
    Tumor marker measurement
    measure the change of tumor marker such as carcinoembryonic antigen (CEA)
    Conduct computed tomography (CT) or magnetic resonance imaging (MRI) scans for tumour response evaluation
    Subjects will still be followed-up in the event of disease progression in order to document overall survival, a secondary endpoint.
    Review concomitant medications
    Use of medications will be reviewed and recorded
    Assess for presence of adverse event
    An adverse event assessment will be performed

    Full Information

    First Posted
    June 27, 2016
    Last Updated
    July 2, 2020
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02841436
    Brief Title
    A Clinical Research About Using Irreversible Electroporation to Treat Locally Advanced Pancreatic Cancer
    Official Title
    A Clinical Research About Using Irreversible Electroporation to Treat Locally Advanced Pancreatic Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    June 16, 2014 (Actual)
    Study Completion Date
    May 27, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Pancreatic cancers is one the most important malignancies with highest mortality in the world. The prognosis of these patients is very poor. Although some patients with early-diagnosed disease could receive surgical intervention, a majority (70%to 80%) of patients present with locally advanced or metastatic status are inoperable. Patients in this late status usually are recommended to receive palliative bypass operation such as choledochojejunostomy and/or gastrojejunostomy and palliative radiotherapy for the pancreatic cancer. Radiofrequency ablation (RFA) used to be expected an alternative therapy. However, the main drawback of RFA is its side effect to damage adjacent structure such as bile duct, and the tumors located adjacent to vessels could not be ablated well.
    Detailed Description
    Irreversible electroporation (IRE), developed and manufactured by AngioDynamics US Ltd, can ablate tumor by fenestrating the cancer cell membrane by electric pulse. The anti-tumor effect does not result from thermotherapy, so is also not diminished by adjacent vessels. Several pre-clinical and clinical studies have already demonstrated IRE is a safe and effective treatment, and the adjacent tissue such as vessels and ductal structures will be spared. Recently, IRE had been used to treat pancreatic cancer successfully, and the safety is satisfactory. The system has been approved as safe by the European Union (EU) in 2008 and received Food and Drug Administration (FDA) approval in 2010. However, there are still few experiences in using IRE for tumor ablation in Taiwan. In this study, the investigators will perform IRE for inoperable patients with locally advanced pancreatic cancers. They will receive IRE during the operation of palliative bypass operation including choledochojejunostomy and/or gastrojejunostomy. The investigators will evaluate the potential side effect and ablate effect of tumors, and also follow-up the patients for 2 years to evaluate the overall survival. The investigators will appraisal the clinical feasibility and advantage of the system by this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Cancer
    Keywords
    irreversible electroporation, pancreatic cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    7 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    irreversible electroporation (IRE)
    Arm Type
    Experimental
    Arm Description
    IRE (AngioDynamics, NY) To use 2 to 6 unipolar electrodes in a predetermined grid pattern. 90 pulses of 2,000 - 3,000 V were applied with a pulse generator (AngioDynamics, NY) across the gap between the electrodes for 100 microseconds (0.1 msec) per each ablation.
    Intervention Type
    Device
    Intervention Name(s)
    Irreversible Electroporation (IRE) System
    Primary Outcome Measure Information:
    Title
    Tumor response
    Description
    Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI).
    Time Frame
    1 month after treatment
    Secondary Outcome Measure Information:
    Title
    Eastern Cooperative Oncology Group (ECOG) evaluation
    Description
    Complete an Eastern Cooperative Oncology Group (ECOG) evaluation
    Time Frame
    one to two years
    Title
    Haematology test
    Description
    complete white blood cell count with differential, red blood cell count, hemoglobin, hematocrit, and platelets
    Time Frame
    one to two years
    Title
    Tumor marker measurement
    Description
    measure the change of tumor marker such as carcinoembryonic antigen (CEA)
    Time Frame
    one to two years
    Title
    Conduct computed tomography (CT) or magnetic resonance imaging (MRI) scans for tumour response evaluation
    Description
    Subjects will still be followed-up in the event of disease progression in order to document overall survival, a secondary endpoint.
    Time Frame
    one to two years
    Title
    Review concomitant medications
    Description
    Use of medications will be reviewed and recorded
    Time Frame
    one to two years
    Title
    Assess for presence of adverse event
    Description
    An adverse event assessment will be performed
    Time Frame
    one to two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for this study: Locally advanced pancreatic cancer is defined as per the 7th edition of the American Joint Committee on Cancer (AJCC) staging system for pancreatic cancer -described as arterial encasement of either the celiac axis or superior mesenteric artery or both. Biliary tract or intestine is compromised by tumor, palliative bypass operation (hepaticojejunostomy and/or gastrojejunostomy) is considered to be performed. Eastern Cooperative Oncology Group (ECOG) score of 0-1, American Society of Anaesthesiologists (ASA) score ≤ 3, Adequate bone marrow, liver and renal function. Platelet count ≥ 100 K/Μl. Total bilirubin ≦ 5 mg/dL. alanine transaminase (ALT) and aspartate transaminase (AST) < 5 x upper limit of normal. prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0 (5). Serum creatinine ≦ 1.5 x upper limit of normal Prior Informed Consent Form Life expectancy of at least 3 months. Exclusion Criteria: Patients presenting with any of the following will not be enrolled into this study: History of cardiac disease: Congestive heart failure >New York Heart Association (NYHA) class 2 Active coronary artery disease (CAD) (myocardial infarction more than 6 months prior to study entry is allowed) Cardiac arrhythmias (>Grade 2 NCI-CTCAE Version 3.0) which are poorly controlled with anti-arrhythmic therapy or requiring pace maker Uncontrolled hypertension Any active metal implanted device (eg Pacemaker), Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, Received treatment with an investigational agent/ procedure within 30 days prior to treatment with the IRE System, Known history of human immunodeficiency virus (HIV) infection Patients with resectable lesions.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kai-Wen Huang, PhD
    Organizational Affiliation
    National Taiwan University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    A Clinical Research About Using Irreversible Electroporation to Treat Locally Advanced Pancreatic Cancer

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