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

Primary Purpose

Hepatocellular Carcinoma, HCC

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy (SBRT)
Trans-Arterial Chemoembolization (TACE)
Doxorubin
Sponsored by
Lahey Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma (HCC), Liver transplant, Bridge to transplant, Stereotactic body radiation therapy (SBRT), Trans-arterial chemoembolization (TACE)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Lahey Hospital & Medical Center
  • Mayo Clinic
  • University of Nebraska Medical Center
  • The Ohio State University Comprehensive Cancer Center
  • Princess Margaret Hospital, UHN

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Stereotactic Body Radiation Therapy (SBRT)

Trans-Arterial Chemoembolization (TACE)

Arm Description

Radiation Therapy

Procedure/Surgery - Chemoembolization Drug: Doxorubin

Outcomes

Primary Outcome Measures

To compare the duration of disease control in treated lesions when utilizing SBRT versus TACE as a bridging strategy for patients with HCC eligible for liver transplantation

Secondary Outcome Measures

To compare participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of further interventions
Rate of pathological response of treated lesion(s)
Rate of radiological response of treated lesion(s)
To assess Quality of Life by Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Questionnaire
A 45-item self-report instrument to measure health-related quality of life (HRQL) in patients with hepatobiliary cancers and is one of the most widely-used instruments in this clinical area. The FACT-Hep consists of the 27-item FACT-G, assesses HRQL, and the 18-item Hepatobiliary Subscale (HS), assesses disease-specific issues such as pain, appetite, and cramping. The FACT-G evaluates physical well-being, social/family well-being, emotional well-being, and functional well-being. Sections have a 7-day reference period and are scored from 0-4 ("not at all" to "very much"), with higher scores indicating better HRQL. Score ranges are 0-28 for physical well-being, 0-28 for social/family well-being, 0-24 for emotional well-being, 0-28 for functional well-being, and 0-72 for the HS. All subscale scores from the FACT-G and HS can be summed together to create a total FACT-Hep score, with a possible range of 0-180. The FACT-Hep takes approximately 10 minutes to complete.
To assess over survival
To assess 90 day Post-transplant morbidity
To assess 90 day Post-transplant mortality

Full Information

First Posted
April 30, 2019
Last Updated
August 2, 2023
Sponsor
Lahey Clinic
Collaborators
Varian Medical Systems, Merit Medical Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03960008
Brief Title
Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant
Acronym
SBRTvsTACE
Official Title
A Randomized Multi-Center Phase III Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as a Bridge to Transplant in Hepatocellular Carcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lahey Clinic
Collaborators
Varian Medical Systems, Merit Medical Systems, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, HCC
Keywords
Hepatocellular Carcinoma (HCC), Liver transplant, Bridge to transplant, Stereotactic body radiation therapy (SBRT), Trans-arterial chemoembolization (TACE)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Body Radiation Therapy (SBRT)
Arm Type
Other
Arm Description
Radiation Therapy
Arm Title
Trans-Arterial Chemoembolization (TACE)
Arm Type
Other
Arm Description
Procedure/Surgery - Chemoembolization Drug: Doxorubin
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy (SBRT)
Other Intervention Name(s)
Radiation Therapy
Intervention Description
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
Procedure
Intervention Name(s)
Trans-Arterial Chemoembolization (TACE)
Other Intervention Name(s)
Chemoembolization
Intervention Description
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
Drug
Intervention Name(s)
Doxorubin
Other Intervention Name(s)
Doxorubin bead therapy
Intervention Description
This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.
Primary Outcome Measure Information:
Title
To compare the duration of disease control in treated lesions when utilizing SBRT versus TACE as a bridging strategy for patients with HCC eligible for liver transplantation
Time Frame
1 year post treatment
Secondary Outcome Measure Information:
Title
To compare participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
At each treatment, 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment
Title
Number of further interventions
Time Frame
2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment
Title
Rate of pathological response of treated lesion(s)
Time Frame
Review of pathology report after liver transplant
Title
Rate of radiological response of treated lesion(s)
Time Frame
Baseline, 2 months post-treatment, 5 months post-treatment, every 3 months thereafter until 2 years post treatment
Title
To assess Quality of Life by Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Questionnaire
Description
A 45-item self-report instrument to measure health-related quality of life (HRQL) in patients with hepatobiliary cancers and is one of the most widely-used instruments in this clinical area. The FACT-Hep consists of the 27-item FACT-G, assesses HRQL, and the 18-item Hepatobiliary Subscale (HS), assesses disease-specific issues such as pain, appetite, and cramping. The FACT-G evaluates physical well-being, social/family well-being, emotional well-being, and functional well-being. Sections have a 7-day reference period and are scored from 0-4 ("not at all" to "very much"), with higher scores indicating better HRQL. Score ranges are 0-28 for physical well-being, 0-28 for social/family well-being, 0-24 for emotional well-being, 0-28 for functional well-being, and 0-72 for the HS. All subscale scores from the FACT-G and HS can be summed together to create a total FACT-Hep score, with a possible range of 0-180. The FACT-Hep takes approximately 10 minutes to complete.
Time Frame
Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatment
Title
To assess over survival
Time Frame
Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatment
Title
To assess 90 day Post-transplant morbidity
Time Frame
Disease status to be captured 90 days post-transplantation (+/- 2 weeks)
Title
To assess 90 day Post-transplant mortality
Time Frame
Survival status to be captured 90 days post-transplantation (+/- 2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. 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. Subjects must be eligible per standard of care for either TACE or SBRT procedures. Subjects must have a life expectancy of at least 12 weeks. 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. Subjects must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of record . Subjects must have a Child-Turcotte-Pugh (CTP) score ≤8. 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). Patients uninvolved liver volume will be estimated and must be > 700ml. Patients must have a Zubrod performance status of ≤2. Exclusion Criteria: Subjects in a "special category" designated by the Public Health Service, Including subjects younger than 18, pregnant women, and prisoners. Refractory ascites that requires paracentesis for management. Known allergy to intravenous iodinated contrast agents unresponsive to prednisone pre-treatment. History of prior radiation to the liver. Evidence of metastatic disease. Presence of a Trans-jugular intra-hepatic porto-systemic shunt (TIPS).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corrine Zarwan, MD
Organizational Affiliation
Lahey Hospital & Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Hospital & Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
Facility Name
Princess Margaret Hospital, UHN
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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