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Radioembolization Versus External Radiation Therapy

ConditionHeptocellular Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: TAREExperimental treatment 1 intervention
Group B: SBRTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of re-treatment over 12 months

Rate of re-treatment of the index lesion over 12 months

Time frame
From enrollment to 12 months following the end of treatment

Secondary outcomes

1

Laboratory toxicities CBC

Laboratory CBC (includes WBC (k/uL), RBC (M/uL), and Platelets (K/uL)

Time frame
From enrollment to 24 months post treatment
2

Laboratory toxicities CMP

Laboratory CMP (includes Sodium (mmol/L), Creatine (mg/dL), Total Bilirubin (mg/dL), ALP (IU/L), AST/SGOT (IU/L), ALT/SGPT (IU/L), Serum Albumin (g/dl), INR (unitless), AFP (ng/mL)

Time frame
From enrollment to 24 months post treatment
3

Laboratory toxicities INR

Laboratory INR (unitless)

Time frame
From enrollment to 24 months post treatment
4

Laboratory toxicities AFP

Laboratory AFP (ng/mL)

Time frame
From enrollment to 24 months post treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henry Ford Health System

Lead sponsor

Source ClinicalTrials.gov
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