Radioembolization Versus External Radiation Therapy
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Henry Ford Health System
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- Rate of re-treatment over 12 months
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- 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
Arms & Interventions
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.
Intervention: Transarterial Radioembolization (Radiation)
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.
Intervention: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
Outcomes
Primary Outcomes
Rate of re-treatment over 12 months
Time Frame: From enrollment to 12 months following the end of treatment
Rate of re-treatment of the index lesion over 12 months
Secondary Outcomes
- Laboratory toxicities CBC(From enrollment to 24 months post treatment)
- Laboratory toxicities CMP(From enrollment to 24 months post treatment)
- Laboratory toxicities INR(From enrollment to 24 months post treatment)
- Laboratory toxicities AFP(From enrollment to 24 months post treatment)
- Clinical toxicities(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.(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.(From enrollment to 1, 3, and 6 months post treatment)
- Disease Free Survival(From enrollment to 24 months post treatment)
- Local Control(From enrollment to 6 months post treatment)
- Overall Survival(From enrollment to 24 months post treatment)
Investigators
Reena Salgia
Principal Investigator
Henry Ford Health System