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Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant

NCT03960008 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-08-28

Study results available
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Summary

This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to liver transplantation in subjects with HCC.

Conditions

Interventions

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

SBRT will be delivered in five total fractions, with at a minimum of one day between any two treatments. The entire treatment must be delivered within 15 total days.

PROCEDURE

Trans-Arterial Chemoembolization (TACE)

First day will be administered and a second TACE will be administered after 4 weeks and subsequently if imaging is showing disease progression. Following each TACE procedure all patients will remain in hospital for observation

DRUG

Doxorubin

This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.

Sponsors & Collaborators

  • Varian Medical Systems

    collaborator INDUSTRY

  • Merit Medical Systems, Inc.

    collaborator INDUSTRY

  • Lahey Clinic

    lead OTHER

Principal Investigators

  • Corrine Zarwan, MD · Lahey Hospital & Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2024-02-28
Completion
2024-02-28
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03960008 on ClinicalTrials.gov