Title
Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant
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.
Phase
Phase 3Lead Sponsor
Tufts UniversityStudy Type
InterventionalStatus
Active, not recruitingIndication/Condition
HCC ...Intervention/Treatment
Doxorubin ...Study Participants
196This 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.
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.
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.
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
This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.
Radiation Therapy
Procedure/Surgery - Chemoembolization Drug: Doxorubin
Inclusion Criteria: 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). Patients uninvolved liver volume will be estimated and must be > 700ml. Patients must have a Zubrod performance status of ≤2. Exclusion Criteria: 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).
