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A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01522937
First received: September 23, 2011
Last updated: January 18, 2017
Last verified: January 2017
Results First Received: January 18, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Liver Cancer
Hepatocellular Cancer
Intervention: Radiation: individualized Stereotactic Body Radiation Therapy (SBRT)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Liver Cancer Patients

The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).

individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment.


Participant Flow:   Overall Study
    Liver Cancer Patients
STARTED   146 
COMPLETED   146 
NOT COMPLETED   0 



  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.
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Reporting Groups
  Description
Liver Cancer Patients

The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).

individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment.


Baseline Measures
   Liver Cancer Patients 
Overall Participants Analyzed 
[Units: Participants]
 146 
Age 
[Units: Years]
Mean (Full Range)
 65 
 (25 to 86) 
Gender 
[Units: Participants]
Count of Participants
 
Female      30  20.5% 
Male      116  79.5% 


  Outcome Measures
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1.  Primary:   The Percentage of Patients With Local Control at 1 Year Post Treatment   [ Time Frame: 1 Year ]

2.  Secondary:   The Percentage of Patients Alive Without Progression at 1 Year   [ Time Frame: 1 Year ]

3.  Secondary:   The Percentage of Patients Alive at 1 Year   [ Time Frame: 1 Year ]

4.  Secondary:   The Number of Patients Who Experience Grade 4+ Hepatotoxicity   [ Time Frame: 1 Year ]

5.  Secondary:   The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding   [ Time Frame: 1 Year ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Kyle Cuneo, M.D.
Organization: University of Michigan Comprehensive Cancer Center
phone: 734-936-4300
e-mail: kcuneo@umich.edu



Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01522937     History of Changes
Other Study ID Numbers: UMCC 2009-053
HUM00029467 ( Other Identifier: University of Michigan Medical IRB )
Study First Received: September 23, 2011
Results First Received: January 18, 2017
Last Updated: January 18, 2017