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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 - 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
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.
  • 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.

Recruiting Locations

Henry Ford Health System
Detroit, Michigan 48202
Contact:
Marissa Gilbert
3135568422
mgilber6@hfhs.org

More Details

Status
Recruiting
Sponsor
Henry Ford Health System

Study Contact

Marissa Gilbert
313-556-8422
mgilber6@hfhs.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.