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

NCT ID: NCT03960008

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2024-02-28

Brief 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.

Detailed Description

For patients with hepatocellular carcinoma (HCC) who are waiting for a liver transplant, local treatment of their disease has become the standard of care in an effort to decrease dropout rates and as a means of reducing tumor recurrence after transplantation. For patients undergoing local regional therapy as a bridge to transplantation, trans-arterial chemoembolization (TACE) is the most commonly utilized treatment. However, the best modality for patients undergoing treatment as a bridge to transplantation is unclear. A newer strategy for the treatment of HCC is stereotactic body radiation therapy (SBRT). This study will compare SBRT to TACE as a bridging strategy for patients with HCC undergoing liver transplantation.

Conditions

Hepatocellular Carcinoma; HCC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stereotactic Body Radiation Therapy (SBRT)

Radiation Therapy

Group Type: OTHER

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type: RADIATION

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.

Trans-Arterial Chemoembolization (TACE)

Procedure/Surgery - Chemoembolization Drug: Doxorubin

Group Type: OTHER

Trans-Arterial Chemoembolization (TACE)

Intervention Type: PROCEDURE

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

Doxorubin

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: RADIATION

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

Intervention Type: PROCEDURE

Doxorubin

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

Intervention Type: DRUG

Other Intervention Names

Radiation Therapy; Chemoembolization; Doxorubin bead therapy

Eligibility Criteria

Inclusion Criteria

1. Subjects with HCC are eligible for this trial. HCC is defined as having at least one of the following:

• Biopsy proven HCC or:
• A discrete hepatic tumor(s) as defined by the Barcelona (29) criteria for cirrhotic subjects, ≥2cm with arterial hypervascularity and venous or delayed phase washout on CT or MRI.

2. Subjects are liver transplant candidates (actively awaiting organ transplant per transplant services in documentation), or, potential liver transplant candidates (at the discretion of the liver team and/or Principal Investigator) advised by liver transplant services as needing local treatment prior to liver transplant evaluation.

3. Subjects must be within UCSF criteria (one solitary tumor smaller than 6.5 cm, or patients having 3 or fewer nodules, with the largest lesion being smaller than 4.5 cm or having a total tumor diameter less than 8.5 cm without vascular invasion) and eligible for potential liver transplant.

4. Subjects must be eligible per standard of care for either TACE or SBRT procedures.

5. Subjects must have a life expectancy of at least 12 weeks.

6. Subjects must be 18 years of age or older. Adult subjects of all ages, both sexes and all races will be included in this study.

7. Subjects must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of record .

8. Subjects must have a Child-Turcotte-Pugh (CTP) score ≤8.

9. Patients must have adequate organ function within 2 weeks of enrollment.

• Bone marrow: Platelets ≥30,000/mm3
• Renal: BUN ≤40 mg/dl; creatinine ≤2.0 mg/dl
• Hepatic: INR ≤ 1.5 or correctable by Vitamin K, unless anti-coagulated for another medical reason
• Bilirubin < 3.0 mg/dl (in the absence of obstruction or pre-existing disease of the biliary tract, e.g. primary sclerosing cholangitis).

10. Patients uninvolved liver volume will be estimated and must be > 700ml.

11. Patients must have a Zubrod performance status of ≤2.

Exclusion Criteria

1. Subjects in a "special category" designated by the Public Health Service, Including subjects younger than 18, pregnant women, and prisoners.

2. Refractory ascites that requires paracentesis for management.

3. Known allergy to intravenous iodinated contrast agents unresponsive to prednisone pre-treatment.

4. History of prior radiation to the liver.

5. Evidence of metastatic disease.

6. Presence of a Trans-jugular intra-hepatic porto-systemic shunt (TIPS).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Varian Medical Systems

INDUSTRY

Sponsor Role: collaborator

Merit Medical Systems, Inc.

INDUSTRY

Sponsor Role: collaborator

Lahey Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corrine Zarwan, MD

Role: PRINCIPAL_INVESTIGATOR

Lahey Hospital & Medical Center

Locations

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Princess Margaret Hospital, UHN

Toronto, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20193013

Identifier Type: -

Identifier Source: org_study_id