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History of Changes for Study: NCT03960008
Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant (SBRTvsTACE)
Latest version (submitted October 26, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 21, 2019 None (earliest Version on record)
2 May 28, 2019 Outcome Measures and Study Status
3 August 12, 2019 Study Status
4 February 24, 2020 Study Status
5 August 4, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
6 September 10, 2021 Study Status
7 March 21, 2022 Contacts/Locations and Study Status
8 May 31, 2022 Recruitment Status, Contacts/Locations and Study Status
9 October 26, 2022 Study Status
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Study NCT03960008
Submitted Date:  May 21, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: 20193013
Brief Title: Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant (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.
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2019
Overall Status: Not yet recruiting
Study Start: June 2019
Primary Completion: December 2021 [Anticipated]
Study Completion: December 2024 [Anticipated]
First Submitted: April 30, 2019
First Submitted that
Met QC Criteria:
May 21, 2019
First Posted: May 22, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
May 21, 2019
Last Update Posted: May 22, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Lahey Clinic
Responsible Party: Sponsor
Collaborators: Varian Medical Systems
Merit Medical Systems, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
Open or close this module Conditions
Conditions: Hepatocellular Carcinoma
HCC
Keywords: Hepatocellular Carcinoma (HCC)
Liver transplant
Bridge to transplant
Stereotactic body radiation therapy (SBRT)
Trans-arterial chemoembolization (TACE)
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 196 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Stereotactic Body Radiation Therapy (SBRT)
Radiation Therapy
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.
Other Names:
  • Radiation Therapy
Trans-Arterial Chemoembolization (TACE)
Procedure/Surgery - Chemoembolization Drug: Doxorubin
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
Other Names:
  • Chemoembolization
Drug: Doxorubin
This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.
Other Names:
  • Doxorubin bead therapy
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Time to first additional intervention to the treated lesions
[ Time Frame: 1 year post treatment ]

Secondary Outcome Measures:
1. 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 ]

2. 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 ]

3. Rate of pathological response of treated lesion(s)
[ Time Frame: Review of pathology report after liver transplant ]

4. 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 ]

5. To assess Quality of Life by Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Questionnaire
[ Time Frame: Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatment ]

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.
6. 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 ]

7. To assess 90 day Post-transplant morbidity
[ Time Frame: Disease status to be captured 90 days post-transplantation (+/- 2 weeks) ]

8. To assess 90 day Post-transplant mortality
[ Time Frame: Survival status to be captured 90 days post-transplantation (+/- 2 weeks) ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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).
Open or close this module Contacts/Locations
Central Contact Person: Julie Roache
Telephone: 781-744-3055
Email: julia.roache@lahey.org
Study Officials: Francis W. Nugent, III, MD
Principal Investigator
Lahey Hospital & Medical Center
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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