Radioembolization Versus External Radiation Therapy

Overview

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.

Interventions

• Radiation Transarterial 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.
• Radiation Stereotactic 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.

Primary outcome measures

• Rate of re-treatment over 12 months [Time frame: From enrollment to 12 months following the end of treatment]

Secondary outcome measures (10)

• Laboratory toxicities CBC [Time frame: From enrollment to 24 months post treatment]
• Laboratory toxicities CMP [Time frame: From enrollment to 24 months post treatment]
• Laboratory toxicities INR [Time frame: From enrollment to 24 months post treatment]
• Laboratory toxicities AFP [Time frame: From enrollment to 24 months post treatment]
• Clinical toxicities [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. [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. [Time frame: From enrollment to 1, 3, and 6 months post treatment]
• Disease Free Survival [Time frame: From enrollment to 24 months post treatment]
• Local Control [Time frame: From enrollment to 6 months post treatment]
• Overall Survival [Time frame: From enrollment to 24 months post treatment]

Eligibility criteria

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
• 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.
• Known severe allergic reaction (anaphylaxis) to iodinated contrast Coagulopathy that the provider deems would be unsafe for transarterial therapy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Henry Ford Health System — Detroit

Identifiers

NCT: NCT07530172 · 18805

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗