Clinical Trials /

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

NCT03960008

Description:

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.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant
  • 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.

Clinical Trial IDs

  • ORG STUDY ID: 20193013
  • NCT ID: NCT03960008

Conditions

  • Hepatocellular Carcinoma
  • HCC

Interventions

DrugSynonymsArms
DoxorubinDoxorubin bead therapyTrans-Arterial Chemoembolization (TACE)

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Stereotactic Body Radiation Therapy (SBRT)OtherRadiation Therapy
    Trans-Arterial Chemoembolization (TACE)OtherProcedure/Surgery - Chemoembolization Drug: Doxorubin
    • Doxorubin

    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).
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure: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
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure: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
    Safety Issue:
    Description:
    Measure: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
    Safety Issue:
    Description:
    Measure:Rate of pathological response of treated lesion(s)
    Time Frame:Review of pathology report after liver transplant
    Safety Issue:
    Description:
    Measure: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
    Safety Issue:
    Description:
    Measure: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
    Safety Issue:
    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.
    Measure: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
    Safety Issue:
    Description:
    Measure:To assess 90 day Post-transplant morbidity
    Time Frame:Disease status to be captured 90 days post-transplantation (+/- 2 weeks)
    Safety Issue:
    Description:
    Measure:To assess 90 day Post-transplant mortality
    Time Frame:Survival status to be captured 90 days post-transplantation (+/- 2 weeks)
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Lahey Clinic

    Trial Keywords

    • Hepatocellular Carcinoma (HCC)
    • Liver transplant
    • Bridge to transplant
    • Stereotactic body radiation therapy (SBRT)
    • Trans-arterial chemoembolization (TACE)

    Last Updated

    August 4, 2020