Radioembolization Versus External Radiation Therapy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System

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)

Treatment groups

146 Participants
are divided into 2 treatment groups

Sponsors and collaborators