Radioembolization Versus External Radiation Therapy
Henry Ford Health System
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Childs-Pugh score ≤ 8 * ECOG performance status ≤2 * Adequate organ function defined as: * serum bilirubin \< 4.0 mg/dL , * albumin \> 2 g/dL Exclusion Criteria: * Any prior SBRT or radioembolization to the target tumor * Macrovascu…
Interventions
- RadiationTransarterial Radioembolization
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.
- RadiationStereotactic Body Radiation Therapy (SBRT)
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.
Location
- Henry Ford Health SystemDetroit, Michigan