At a glance
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A Randomized Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) With DEBDOX Beads as a Bridge to Transplant in Hepatocellular Carcinoma.
In Brief
A Phase 2 clinical trial evaluating Stereotactic Body Radiation Therapy (SBRT), Trans-Arterial Chemoembolization (TACE), and 1 other intervention for Hepatocellular Carcinoma and HCC. Completed, enrolled 60 participants across 1 site.
Detailed Summary
This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing orthotopic liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to orthotopic liver transplantation.
Study Details
Timeline
Interventions
SBRT will be delivered in five total fractions, with at a minimum of one day between any two treatments. The entire treatment must be delivered within 15 total days.
First day will be administered and a second TACE will be administered after 4 weeks and subsequently if imaging is showing disease progression. Following each TACE procedure all patients will remain in hospital for observation.
This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.