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Microwave Ablation for Pulmonary Metastases From Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
microwave ablation
Sponsored by
The First People's Hospital of Changzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Unresectable pulmonary metastases from colorectal cancer.
  • diagnosis by CT, and confirmed by percutaneous puncture biopsy.
  • Age range 18-70 years old.
  • Eastern Cooperative Oncology Group performance status 0-1.
  • Life expectancy of more than 3 months.
  • Adequate organ function.

Exclusion Criteria:

  • Resectable lung metastases.
  • Life expectancy less than 3 months
  • Patients with cardiac pacemaker, cerebral aneurysm clips, implanted electronic instruments or other metal materials.
  • Coagulopathy with platelet count less than 50000.
  • Active infectious disease.
  • Age below 18 years.
  • Pregnancy of breastfeeding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treated with microwave ablation

    Arm Description

    Patients undergoing MWA for pulmonary metastases from colorectal cancer.

    Outcomes

    Primary Outcome Measures

    Overall Survival (OS)

    Secondary Outcome Measures

    Treatment related adverse events

    Full Information

    First Posted
    July 15, 2015
    Last Updated
    August 11, 2016
    Sponsor
    The First People's Hospital of Changzhou
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02502630
    Brief Title
    Microwave Ablation for Pulmonary Metastases From Colorectal Cancer
    Official Title
    CT-guided Percutaneous Microwave Ablation for Pulmonary Metastases From Colorectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2010 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First People's Hospital of Changzhou

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    (MWA) is the most recent development in the field of local ablative therapies. The aim of this study was to evaluate CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.
    Detailed Description
    From June 2010 to June 2015, 48 unresectable lesions in 32 patients with pulmonary metastases from colorectal cancer were selected for CT-guided microwave ablation. Patients were scheduled for a 1 and 3 month CT follow-up to evaluate lesion diameter.We retrospectively evaluated CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal 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
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treated with microwave ablation
    Arm Type
    Experimental
    Arm Description
    Patients undergoing MWA for pulmonary metastases from colorectal cancer.
    Intervention Type
    Device
    Intervention Name(s)
    microwave ablation
    Intervention Description
    pulmonary metastases from colorectal cancer are destructed/ablated using microwave ablation
    Primary Outcome Measure Information:
    Title
    Overall Survival (OS)
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Treatment related adverse events
    Time Frame
    Eight weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Unresectable pulmonary metastases from colorectal cancer. diagnosis by CT, and confirmed by percutaneous puncture biopsy. Age range 18-70 years old. Eastern Cooperative Oncology Group performance status 0-1. Life expectancy of more than 3 months. Adequate organ function. Exclusion Criteria: Resectable lung metastases. Life expectancy less than 3 months Patients with cardiac pacemaker, cerebral aneurysm clips, implanted electronic instruments or other metal materials. Coagulopathy with platelet count less than 50000. Active infectious disease. Age below 18 years. Pregnancy of breastfeeding.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jingting Jiang, PD
    Organizational Affiliation
    The First People's Hospital of Changzhou
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    28847194
    Citation
    Cheng G, Shi L, Qiang W, Wu J, Ji M, Lu Q, Li X, Xu B, Jiang J, Wu C. The safety and efficacy of microwave ablation for the treatment of CRC pulmonary metastases. Int J Hyperthermia. 2018 Jun;34(4):486-491. doi: 10.1080/02656736.2017.1366553. Epub 2017 Nov 16.
    Results Reference
    derived

    Learn more about this trial

    Microwave Ablation for Pulmonary Metastases From Colorectal Cancer

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