Radioembolization vs External Radiation for Liver Cancer

(REVERT Trial)

Overseen By Marissa Gilbert

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Henry Ford Health System

Disqualifiers: Prior SBRT, Macrovascular invasion, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3-5 weeks

146 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Reena Salgia, MD

Principal Investigator

Henry Ford Health System

Are You a Good Fit for This Trial?

Inclusion Criteria

Ability to provide written informed consent and HIPAA authorization

I am willing and able to follow all study procedures and be available for the study duration.

I am 18 years old or older.

Exclusion Criteria

I have had SBRT or radioembolization to my target tumor before.

I am scheduled to receive systemic therapy as follow-up treatment.

My cancer has invaded large blood vessels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either transarterial radioembolization (TARE) or stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma

3-5 weeks

Multiple visits for treatment delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits

Extended Follow-up

Participants are monitored for long-term outcomes and toxicities

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiation Therapy (SBRT)
• Transarterial Radioembolization

How Is the Trial Designed?

Group I: TARE Experimental Treatment 1 Intervention

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.

Group II: SBRT Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+