This investigational study will evaluate if using a combination of TACE along with high dose SBRT would show improvement in local control in patients with Hepatocellular Carcinoma.
Primary objectives of this research 1. Evaluate the safety of a combination of TACE and high dose SBRT 2. Measure time to progression (TTP) and local recurrence rate of HCC treated with a combination of TACE \& SBRT. Secondary objectives of this research 1. Assess failure patterns and survival of patients treated with TACE \& SBRT. 2. Analyze dose volume characteristics that influence Radiation Induced Liver Disease (RILD) among patients treated with a combination of TACE and SBRT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Safety of a Combination Therapy
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.
Time frame: Baseline to 45 day after completing combination treatment.
Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT.
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.
Time frame: Baseline to up to 2 years after treatment completed
Local Recurrence Rate
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.
Time frame: Baseline to up to 2 years after treatment completed
Percentage of Participants With Overall Survival
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.
Time frame: up to 2 years after treatment completed
Percentage of Participants With Local Failure Patterns
Assess local failure patterns of patients treated with TACE \& SBRT. This is assessed by the percentage of patients where recurrence occurred
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline up to 2 years after treatment completed