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Irreversible Electroporation(IRE) For Unresectable Head and Neck Neoplasms

Sponsor
Fuda Cancer Hospital, Guangzhou (Other)
Overall Status
Completed
CT.gov ID
NCT02335112
Collaborator
(none)
15
Enrollment
1
Location
3
Arms
72
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Head and Neck Neoplasms.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Irreversible electroporation (IRE)
  • Device: NanoKnife
 N/A

Detailed Description

By enrolling patients with unresectable Head and Neck Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Head and Neck Neoplasms.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Irreversible Electroporation(IRE) For Unresectable Head and Neck Neoplasms: Phase I and Phase II Clinical Trial
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

irreversible electroporation with voltage in level A for Unresectable Head and Neck Neoplasms

Procedure: Irreversible electroporation (IRE)
Irreversible Electroportion For Unresectable Head and Neck Neoplasms guide with ultrasound or/and CT.
Other Names:
  • NanoKnife

    • Device: NanoKnife
    Experimental: Group B

    irreversible electroporation with voltage in level B for Unresectable Head and Neck Neoplasms

    Procedure: Irreversible electroporation (IRE)
    Irreversible Electroportion For Unresectable Head and Neck Neoplasms guide with ultrasound or/and CT.
    Other Names:
  • NanoKnife

    • Device: NanoKnife
    Experimental: Group C

    irreversible electroporation with voltage in level C for Unresectable Head and Neck Neoplasms

    Procedure: Irreversible electroporation (IRE)
    Irreversible Electroportion For Unresectable Head and Neck Neoplasms guide with ultrasound or/and CT.
    Other Names:
  • NanoKnife

    • Device: NanoKnife

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with Adverse events [6 month]

    Secondary Outcome Measures

    1. Percentage of lesions that show no sign of recurrence 12 months after IRE [12 months]

    2. Voltage (A minimum and maximum range of voltage for safe and effective IRE) [3 months]

      A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.

    3. Progress free disease (PFS) [12 months]

    4. Overall survival (OS) [36 months]

      Patients will be followed for 36 months after IRE for OS analyzed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Head and Neck Neoplasms diagnosed by positive biopsy or non-invasive criteria,

    • Not suitable for surgical resection,

    • Eastern Cooperative Oncology Group (ECOG) score of 0-1,

    • A prothrombin time ratio > 50%,

    • Platelet count > 80x10^9/L,

    • Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,

    • Able to comprehend and willing to sign the written informed consent form (ICF),

    • Have a life expectancy of at least 3 months.

    Exclusion Criteria:

    • Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,

    • Any active implanted device (eg Pacemaker),

    • Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,

    • Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,

    • Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Biological treatment center in Fuda cancer hospital Guangzhou Guangdong China 510000

    Sponsors and Collaborators

    • Fuda Cancer Hospital, Guangzhou

    Investigators

    • Study Chair: Lizhi Niu, PHD, Fuda Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fuda Cancer Hospital, Guangzhou
    ClinicalTrials.gov Identifier:
    NCT02335112
    Other Study ID Numbers:
    • ZhangZhikai-IRE-02
    First Posted:
    Jan 9, 2015
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Apr 1, 2019
    Keywords provided by Fuda Cancer Hospital, Guangzhou
    irreversible electroporation
    Unresectable Head and Neck Neoplasms
    Additional relevant MeSH terms:
    Neoplasms
    Head and Neck Neoplasms

    Study Results

    No Results Posted as of Sep 5, 2021