The proposed study is a single site, prospective, randomized phase 2 study to evaluate the efficacy and tolerability transarterial radioembolization (TARE) versus stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma. The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety. The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue. The primary endpoint is the rate of re-treatment of the index lesion over 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
146
The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue.
The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety.
Henry Ford Health System
Detroit, Michigan, United States
RECRUITINGRate of re-treatment over 12 months
Rate of re-treatment of the index lesion over 12 months
Time frame: From enrollment to 12 months following the end of treatment
Laboratory toxicities CBC
Laboratory CBC (includes WBC (k/uL), RBC (M/uL), and Platelets (K/uL)
Time frame: From enrollment to 24 months post treatment
Laboratory toxicities CMP
Laboratory CMP (includes Sodium (mmol/L), Creatine (mg/dL), Total Bilirubin (mg/dL), ALP (IU/L), AST/SGOT (IU/L), ALT/SGPT (IU/L), Serum Albumin (g/dl), INR (unitless), AFP (ng/mL)
Time frame: From enrollment to 24 months post treatment
Laboratory toxicities INR
Laboratory INR (unitless)
Time frame: From enrollment to 24 months post treatment
Laboratory toxicities AFP
Laboratory AFP (ng/mL)
Time frame: From enrollment to 24 months post treatment
Clinical toxicities
Clinical toxicities measured using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Scale of 1 to 5 with 5 being the worst outcome.
Time frame: From enrollment to 24 months post treatment
Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) version 4.0 from baseline. Scale of 0 to 4 with 4 being the worst outcome.
Change in patient reported outcomes
Time frame: From enrollment to 1, 3, and 6 months post treatment
Change in COST: A FACIT Measure of Financial Toxicity (FACIT-COST) version 2.0 from baseline. Scale of 0 to 4 with 4 being the worst outcome.
Change in patient reported outcomes
Time frame: From enrollment to 1, 3, and 6 months post treatment
Disease Free Survival
DFS at 2 years
Time frame: From enrollment to 24 months post treatment
Local Control
LC at 6 months after completion of treatment using LIRADS on multiphase CT or MR
Time frame: From enrollment to 6 months post treatment
Overall Survival
OS at 2 years
Time frame: From enrollment to 24 months post treatment
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