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

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ClinicalTrials.gov Identifier: NCT03960008
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : February 25, 2020
Sponsor:
Collaborators:
Varian Medical Systems
Merit Medical Systems, Inc.
Information provided by (Responsible Party):
Lahey Clinic

Tracking Information
First Submitted Date  ICMJE April 30, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date February 25, 2020
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
Time to first additional intervention to the treated lesions [ Time Frame: 1 year post treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • 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 ]
  • 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 ]
  • Rate of pathological response of treated lesion(s) [ Time Frame: Review of pathology report after liver transplant ]
  • 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 ]
  • 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.
  • 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 ]
  • To assess 90 day Post-transplant morbidity [ Time Frame: Disease status to be captured 90 days post-transplantation (+/- 2 weeks) ]
  • To assess 90 day Post-transplant mortality [ Time Frame: Survival status to be captured 90 days post-transplantation (+/- 2 weeks) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatocellular Carcinoma
  • HCC
Intervention  ICMJE
  • 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 Name: Radiation Therapy
  • 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 Name: Chemoembolization
  • Drug: Doxorubin
    This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.
    Other Name: Doxorubin bead therapy
Study Arms  ICMJE
  • Stereotactic Body Radiation Therapy (SBRT)
    Radiation Therapy
    Intervention: Radiation: Stereotactic Body Radiation Therapy (SBRT)
  • Trans-Arterial Chemoembolization (TACE)
    Procedure/Surgery - Chemoembolization Drug: Doxorubin
    Interventions:
    • Procedure: Trans-Arterial Chemoembolization (TACE)
    • Drug: Doxorubin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019)
196
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julie Roache 781-744-3055 julia.roache@lahey.org
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960008
Other Study ID Numbers  ICMJE 20193013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lahey Clinic
Study Sponsor  ICMJE Lahey Clinic
Collaborators  ICMJE
  • Varian Medical Systems
  • Merit Medical Systems, Inc.
Investigators  ICMJE
Principal Investigator: Francis W. Nugent, III, MD Lahey Hospital & Medical Center
PRS Account Lahey Clinic
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP