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

NCT ID: NCT02182687

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2021-10-31

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 orthotopic 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 orthotopic liver transplantation.

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. However, the best modality for patients undergoing treatment as a bridge to transplantation is unclear. This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing orthotopic 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 orthotopic liver transplantation.

Conditions

Hepatocellular Carcinoma; HCC

Study Design

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

Study Groups

Arm A

Stereotactic Body Radiation Therapy (SBRT)

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.

Arm B

Trans-Arterial Chemoembolization (TACE) 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

• Patients with hepatocellular carcinoma are eligible for this trial.

Hepatocellular carcinoma is defined as having at least one of the following:

Biopsy proven hepatocellular carcinoma (HCC); or A discrete hepatic tumor(s) as defined by the Barcelona (29) criteria for cirrhotic patients, >2cm with arterial hypervascularity and venous or delayed phase washout on CT or MRI.

• Patient is within Milan Criteria and "listed" for orthotopic liver transplantation.
• Patients must have a Zubrod performance status of ≤2.
• Patients must have a life expectancy of at least 12 weeks.
• Patients must be 18 years of age or older. Adult patients of all ages, both sexes and all races will be included in this study.
• Patients must be Child-Turcotte-Pugh (CTP) Class A or Class B (≤ 7).
• Female patients within reproductive years may not be, nor become, pregnant during participation in this study. Both male and female patients within reproductive years must agree to use an effective contraceptive method during treatment. Women of childbearing age will be required to undergo a urine or serum pregnancy test to ensure they are not pregnant.
• 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 mg/dl (in the absence of obstruction or pre-existing disease of the biliary tract, e.g. primary sclerosing cholangitis) Patients uninvolved liver volume will be estimated and must be > 700ml.
• Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the Lahey Hospital and Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.

Exclusion Criteria

• Patients in a "special category" designated the Public Health Service, including patients younger than 18, pregnant women, and prisoners.
• Refractory ascites or ascites that requires paracentesis for management.
• Patients with a solitary lesion greater than 5.0cm in size or more than 2 discrete lesions the largest greater than 3.0 cm in size.
• Known allergy to intravenous iodinated contrast agents unresponsive to prednisone pre-treatment.

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

Sponsors

Varian Medical Systems

INDUSTRY

Sponsor Role: collaborator

Lahey Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis W Nugent, MD

Role: PRINCIPAL_INVESTIGATOR

Lahey Hospital & Medical Center

Locations

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LCID 2014-026

Identifier Type: -

Identifier Source: org_study_id