Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer

This study has been terminated.
(Principal investigator left the institution.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Caryn Steakley, R.N., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00019604
First received: July 11, 2001
Last updated: May 13, 2014
Last verified: May 2014
Results First Received: April 1, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Liver Cancer
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Procedure: computed tomography
Procedure: magnetic resonance imaging
Procedure: positron emission tomography
Procedure: radiofrequency ablation
Procedure: radionuclide imaging
Procedure: ultrasound imaging
Radiation: fludeoxyglucose F 18 (FDG-PET)
Radiation: gadopentetate dimeglumine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Radiofrequency Ablation in Liver Cancer This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.

Participant Flow:   Overall Study
    Radiofrequency Ablation in Liver Cancer  
STARTED     44  
COMPLETED     5  
NOT COMPLETED     39  
Death                 1  
Progressive disease                 23  
Refused treatment                 1  
Carcinoid tumor, not treatable                 1  
Going to have liver transplant                 1  
Move to a different study                 1  
Non compliant on systemic CH                 1  
Non compliant                 1  
Resectable disease                 1  
Started new chemo regimen                 1  
Pt going to immunotherapy study                 1  
Too much disease                 1  
Unable to evaluate                 1  
Details for other not available                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Radiofrequency Ablation in Liver Cancer This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.

Baseline Measures
    Radiofrequency Ablation in Liver Cancer  
Number of Participants  
[units: participants]
  44  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     27  
>=65 years     17  
Age  
[units: years]
Mean ± Standard Deviation
  59.18  ± 13.19  
Gender  
[units: participants]
 
Female     21  
Male     23  
Ethnicity (NIH/OMB)  
[units: Participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     44  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: Participants]
 
American Indian or Alaska Native     0  
Asian     5  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     35  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     44  



  Outcome Measures
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1.  Primary:   Response   [ Time Frame: unknown ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 9 years, 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Adverse event data is available but the format is uninterpretable.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Caryn Steakley
Organization: National Cancer Institute, National Institutes of Health
phone: 301-435-3685
e-mail: steaklec@mail.nih.gov


No publications provided


Responsible Party: Caryn Steakley, R.N., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00019604     History of Changes
Obsolete Identifiers: NCT00001795
Other Study ID Numbers: 990025, 99-C-0025, CDR0000066875
Study First Received: July 11, 2001
Results First Received: April 1, 2014
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration