Radioembolization Versus External Radiation Therapy

Conditions

• Heptocellular Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Transarterial Radioembolization — RADIATION
  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.
• Stereotactic Body Radiation Therapy (SBRT) — RADIATION
  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.

Study Details

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.

Key Dates

Start date

Dec 8, 2025

Status verified

Apr 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2029

Study Design

Enrollment

146 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: TARE
  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.
• Experimental: 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 Measure

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

Central Contacts

• Marissa Gilbert
  313-556-8422
  [email protected]

Locations (1)

Find similar trials in Detroit, MI