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Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms

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ClinicalTrials.gov Identifier: NCT02425059
Recruitment Status : Recruiting
First Posted : April 23, 2015
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Rectal Neoplasms.

Condition or disease Intervention/treatment Phase
Rectal Neoplasms Procedure: Irreversible electroporation (IRE) Device: NanoKnife Phase 1 Phase 2

Detailed Description:
By enrolling patients with unresectable Rectal 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 Rectal Neoplasms.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms: Phase I and Phase II Clinical Trial
Study Start Date : January 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: IRE Group
irreversible electroporation for Unresectable Rectal Neoplasms
Procedure: Irreversible electroporation (IRE)
Irreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT.

Device: NanoKnife



Primary Outcome Measures :
  1. Number of participants with Adverse events [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Percentage of lesions that show no sign of recurrence 12 months after IRE [ Time Frame: 12 months ]

Other Outcome Measures:
  1. A minimum and maximum range of voltage for safe and effective IRE [ Time Frame: 3 months ]
    A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.

  2. Progress free disease (PFS) [ Time Frame: 12 months ]
  3. Overall survival (OS) [ Time Frame: 36 mouths ]
    Patients will be followed for 36 months after IRE for OS analyzed.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rectal 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425059


Contacts
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Contact: Lizhi Niu, PhD niuboshi@fudahospital.com

Locations
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China, Guangdong
Biological treatment center in Fuda cancer hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Chen Jibing, PhD    +86-18903068207    jibingchen398@163.com   
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Investigators
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Study Chair: Lizhi Niu, PhD Fuda Cancer Hospital

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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02425059     History of Changes
Other Study ID Numbers: Rectal cancer-IRE-01
First Posted: April 23, 2015    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016

Keywords provided by Fuda Cancer Hospital, Guangzhou:
irreversible electroporation
Unresectable Rectal Neoplasms

Additional relevant MeSH terms:
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Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases