A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma (RAD 0902)
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|ClinicalTrials.gov Identifier: NCT01247298|
Recruitment Status : Completed
First Posted : November 24, 2010
Results First Posted : June 19, 2017
Last Update Posted : August 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma (HCC)||Combination Product: Stereotactic Body Radiation Therapy (SBRT)||Early Phase 1|
Primary objectives of this research
- Evaluate the safety of a combination of TACE and high dose SBRT
- Measure time to progression (TTP) and local recurrence rate of HCC treated with a combination of TACE & SBRT.
Secondary objectives of this research
- Assess failure patterns and survival of patients treated with TACE & SBRT.
- Analyze dose volume characteristics that influence Radiation Induced Liver Disease (RILD) among patients treated with a combination of TACE and SBRT.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||RAD 0902: A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Stereotactic Body Radiation Therapy (SBRT)
Patients will receive stereotactic body radiation therapy (SBRT) which is 3 radiation treatments at 15 Gy, for a total of 45 Gy. Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. (TACE is not performed as part of this clinical study, even though it is part of the inclusion criteria.)
Combination Product: Stereotactic Body Radiation Therapy (SBRT)
This investigational study will evaluate the combination of TACE along with high dose SBRT. TACE has been used extensively in the palliative treatment of hepatocellular carcinoma (HCC). It will be performed by the Interventional Radiologist prior to radiation therapy.
Other Name: TACE
- Safety of a Combination Therapy [ Time Frame: Baseline to 45 day after completing combination treatment. ]Evaluate the safety of a combination of TACE and high dose SBRT. Patients were evaluated for toxicity during their follow-up exams every 3 months for 2 years while participating in this study. Patients were also instructed to notify the PI between visits if any related toxicity issues occurred.
- Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT. [ Time Frame: Baseline to up to 2 years after treatment completed ]Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months until complete response or progression. This will be measured by tumor progression and/or death on follow-up imaging from completion of treatment.
- Local Recurrence Rate [ Time Frame: Baseline to up to 2 years after treatment completed ]Evaluate the number of patients with local recurrence. Patient will be asked to visit their study doctor for follow-up exams every 3 months for 2 years while participating in this study.Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months. This will be measured by number of patients with recurrence on their follow-up imaging.
- Percentage of Participants With Overall Survival [ Time Frame: up to 2 years after treatment completed ]Assess overall survival (OS) of patients treated with TACE & SBRT. This is assessed by the length of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease are still alive.
- Percentage of Participants With Local Failure Patterns [ Time Frame: Baseline up to 2 years after treatment completed ]Assess local failure patterns of patients treated with TACE & SBRT. This is assessed by the percentage of patients where recurrence occurred
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): NCT01247298
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||Rojymon Jacob, MD, FRCR||University of Alabama at Birmingham/Department of Radiation Oncology|
|Principal Investigator:||Derek A. Dubay, MD||University of Alabama at Birmingham Department of Hepatobiliary Surgery|