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

NCT03960008 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 20193013
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 5

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.

Conditions

Hepatocellular Carcinoma; HCC

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  To compare whether or not there was disease present in treated lesions in both the SBRT and TACE arms in patients eligible for liver transplant at 1 year post treatment.

  1 year post treatment

Secondary Outcomes (8)

• To Compare Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0

  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

  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)

  Review of pathology report after liver transplant

• Rate of Radiological Response of Treated Lesion(s)

  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

  Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatment

Study Arms (2)

Stereotactic Body Radiation Therapy (SBRT)

OTHER

Radiation Therapy

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Trans-Arterial Chemoembolization (TACE)

OTHER

Procedure/Surgery - Chemoembolization Drug: Doxorubin

Procedure: Trans-Arterial Chemoembolization (TACE); Drug: Doxorubin

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

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.

Also known as: Radiation Therapy

Stereotactic Body Radiation Therapy (SBRT)

Trans-Arterial Chemoembolization (TACE) PROCEDURE

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

Also known as: Chemoembolization

Trans-Arterial Chemoembolization (TACE)

Doxorubin DRUG

This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.

Also known as: Doxorubin bead therapy

Trans-Arterial Chemoembolization (TACE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lahey Clinic: lead
• Varian Medical Systems: collaborator
• Merit Medical Systems, Inc.: collaborator

Study Sites (5)

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43202, United States

Location

Princess Margaret Hospital, UHN

Toronto, Ontario, M5G 1X6, Canada

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery; Radiotherapy; Chemoembolization, Therapeutic; Doxorubicin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Embolization, Therapeutic; Hemostatic Techniques; Therapeutic Occlusion; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Limitations and Caveats

This study closed to accrual early, with the limited number of participants, we were unable to analyze the data.

Results Point of Contact

• Title: Julia Roache, Manger, Research Programs
• Organization: Lahey Hospital & Medical Center

julia.roache@lahey.org

7817443055

Study Officials

• Corrine Zarwan, MD

  Lahey Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 22, 2019
• Study Start: March 1, 2020
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: August 28, 2024
• Results First Posted: August 28, 2024

Record last verified: 2024-08

Locations

CA (1); US (4)