A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
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|ClinicalTrials.gov Identifier: NCT01522937|
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer Hepatocellular Cancer||Radiation: individualized Stereotactic Body Radiation Therapy (SBRT)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Experimental: 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).
Radiation: 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.
- The Percentage of Patients With Local Control at 1 Year Post Treatment [ Time Frame: 1 Year ]For this study, local control is defined as the lack of progressive local disease following CR (Complete Response) or PR (Partial Response), or lack of progressive local disease in patients with non-evaluable disease, who have no progressive elevation in serum tumor markers.
- The Percentage of Patients Alive Without Progression at 1 Year [ Time Frame: 1 Year ]Progression is defined as a greater than or equal to 20% growth of a lesion from the smallest lesion measurement
- The Percentage of Patients Alive at 1 Year [ Time Frame: 1 Year ]
- The Number of Patients Who Experience Grade 4+ Hepatotoxicity [ Time Frame: 1 Year ]Grade 4 toxicities are life threatening toxicities that require urgent attention.
- The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding [ Time Frame: 1 Year ]Grade 4 toxicities are life threatening toxicities that require urgent attention.
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): NCT01522937
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-5010|
|Principal Investigator:||Kyle Cuneo, MD||University of Michigan Cancer Center|