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

Primary Purpose

Hepatocellular Carcinoma, HCC

Status
Completed
Phase
Phase 2
Locations
United States
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), Orthotopic 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

  • 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.

Sites / Locations

  • Lahey Hospital & Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Arm A

Arm B

Arm Description

Stereotactic Body Radiation Therapy (SBRT)

Trans-Arterial Chemoembolization (TACE) Drug: Doxorubin

Outcomes

Primary Outcome Measures

Time to first additional intervention to the treated lesions

Secondary Outcome Measures

Toxicity
Number of further interventions
Pathologic response of treated lesion(s)
Radiologic response of treat lesion(s)
Quality of Life

Full Information

First Posted
June 23, 2014
Last Updated
December 3, 2021
Sponsor
Lahey Clinic
Collaborators
Varian Medical Systems
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1. Study Identification

Unique Protocol Identification Number
NCT02182687
Brief Title
Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as Bridge to Liver Transplant
Acronym
SBRTvsTACE
Official Title
A Randomized Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) With DEBDOX Beads as a Bridge to Transplant in Hepatocellular Carcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 2021 (Actual)
Study Completion Date
October 2021 (Actual)

3. Sponsor/Collaborators

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

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.
No
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 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.

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), Orthotopic liver transplant, Bridge to transplant, stereotactic body radiation therapy (SBRT), trans-arterial chemoembolization (TACE)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Other
Arm Description
Stereotactic Body Radiation Therapy (SBRT)
Arm Title
Arm B
Arm Type
Other
Arm Description
Trans-Arterial Chemoembolization (TACE) 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
Time to first additional intervention to the treated lesions
Time Frame
1 year post treatment
Secondary Outcome Measure Information:
Title
Toxicity
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
Pathologic response of treated lesion(s)
Time Frame
After liver transplant
Title
Radiologic response of treat lesion(s)
Time Frame
Baseline, 2 months post-treatment, 5 months post-treatment, every 3 months thereafter until 2 years post treatment
Title
Quality of Life
Time Frame
Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis W Nugent, 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

12. IPD Sharing Statement

Plan to Share IPD
No

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

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