Radioembolization vs External Radiation for Liver Cancer
(REVERT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines two treatments for liver cancer: transarterial radioembolization and external radiation. Radioembolization sends tiny radioactive beads directly to the liver tumor, while external radiation, known as Stereotactic Body Radiation Therapy (SBRT), uses targeted beams from outside the body. The trial aims to determine which treatment is more effective and easier for patients to tolerate. Individuals with liver cancer, up to three tumors, and no prior experience with these treatments may find this trial suitable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that transarterial radioembolization (TARE) is safe. Approximately 17.1% of patients experienced serious side effects, such as pain or fever, but these occurred less frequently than with other similar treatments.
Research on stereotactic body radiation therapy (SBRT) has found it to be a safe option with manageable side effects. Studies indicate it effectively controls cancer with acceptable levels of liver damage. Both TARE and SBRT have safety records that make them reasonable options for liver cancer patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer new approaches to tackling liver cancer. Unlike traditional external beam radiation therapy, Stereotactic Body Radiation Therapy (SBRT) delivers radiation with precision over just a few sessions, potentially minimizing damage to healthy tissue. Transarterial Radioembolization (TARE), on the other hand, uses tiny radioactive beads, like Yttrium-90, delivered directly into the liver's blood vessels, targeting the tumor more directly. These methods could enhance effectiveness and reduce side effects compared to the standard treatments for liver cancer.
What evidence suggests that this trial's treatments could be effective for liver cancer?
This trial will compare two treatments for liver cancer: transarterial radioembolization (TARE) and stereotactic body radiation therapy (SBRT). Research has shown that TARE with Yttrium-90 can effectively treat liver cancer, often delaying cancer progression and improving survival rates compared to some other treatments. Specifically, TARE has demonstrated better outcomes than traditional chemoembolization for hepatocellular carcinoma, a type of liver cancer. Meanwhile, SBRT effectively targets and controls liver tumors, with a 5-year local control rate of 95% in primary liver cancer cases. Both treatments have shown promising results, making them potential options for managing liver cancer in this trial.46789
Who Is on the Research Team?
Reena Salgia, MD
Principal Investigator
Henry Ford Health System
Are You a Good Fit for This Trial?
This trial is for adults (18+) with up to 3 liver cancer tumors who have good organ function and overall health. Participants can't join if they've had prior radiation or radioembolization to the tumor, are pregnant, have severe allergies to contrast dye, blood clotting problems, or certain advanced disease features.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either transarterial radioembolization (TARE) or stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extended Follow-up
Participants are monitored for long-term outcomes and toxicities
What Are the Treatments Tested in This Trial?
Interventions
- Stereotactic Body Radiation Therapy (SBRT)
- Transarterial Radioembolization
Trial Overview
The study compares two treatments for liver cancer: transarterial radioembolization (TARE), which delivers radioactive beads directly into the tumor's blood supply, versus stereotactic body radiation therapy (SBRT), a precise form of external radiation given over several sessions. Patients are randomly assigned to one group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry Ford Health System
Lead Sponsor
Citations
Long term outcomes of Stereotactic Body Radiation Therapy ...
Median OS of those who underwent liver transplant after SBRT has not been reached, and it was 24 months (95% CI=20·5–27·2) in patients who did not undergo ...
Stereotactic body radiotherapy in early-stage hepatocellular ...
This systematic review and meta-analysis showed that SBRT is an effective and safe treatment modality for treatment-naive patients with early- ...
Final Results of a Multicenter Prospective Study ...
A multicenter prospective study of stereotactic body radiation therapy for previously untreated solitary primary hepatocellular carcinoma.
Long-term outcomes of more than a decade treating ...
SBRT resulted in a 5-year LC of 95% in the treatment of primary liver cancer (HCC). •. No SBRT related ≥ grade 3 toxicity was reported. •. Treatment outcomes of ...
Stereotactic Body Radiation Therapy for Hepatocellular ...
This systematic review and meta-analysis reports on outcomes and hepatic toxicity rates after stereotactic body radiation therapy (SBRT) for liver-confined ...
Stereotactic body radiation therapy in primary liver tumor
SBRT provides good LC with an acceptable safety profile. It can be used in several settings such as salvage therapy or in combination with validated treatment.
Stereotactic Body Radiation Therapy for Hepatocellular ...
This systematic review and meta-analysis reports on outcomes and hepatic toxicity rates after stereotactic body radiation therapy (SBRT) for liver-confined ...
Stereotactic body radiation therapy for centrally located ... - PMC
Abstract. Purpose. To examine safety and efficacy of stereotactic body radiation therapy (SBRT) for centrally located hepatocellular carcinoma (CL-HCC).
Stereotactic body radiation therapy in primary liver tumor
Stereotactic body radiation therapy is a curative alternative for HCC. · Efficacy and safety of SBRT appear to be the same as those of thermoablation or surgery.
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