About this trial
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.
Eligibility criteria
Qualifiers
Ability to provide written informed consent and HIPAA authorization
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged ≥ 18 years at time of informed consent
No more than 3 lesions of HCC evaluated to be eligible for TARE or SBRT at multidisciplinary tumor board
Disqualifiers
Any prior SBRT or radioembolization to the target tumor
Macrovascular invasion
Planned or recommended systemic therapy as consolidation
Pregnancy or lactation: Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration.
Trial design
Treatments tested in this trial
- Transarterial Radioembolization
- Stereotactic Body Radiation Therapy (SBRT)