Clinical trial NCT02182687: Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as Bridge to Liver Transplant
Official title: A Randomized Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) With DEBDOX Beads as a Bridge to Transplant in Hepatocellular Carcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
HCC
Keywords: Hepatocellular carcinoma (HCC)
Orthotopic liver transplant
Bridge to transplant
stereotactic body radiation therapy (SBRT)
trans-arterial chemoembolization (TACE)
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2014-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 orthotopic 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 orthotopic liver transplantation.

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. However, the best modality for patients undergoing treatment as a bridge to transplantation is unclear. This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing orthotopic 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 orthotopic liver transplantation.

Eligibility criteria: Inclusion Criteria

* Patients with hepatocellular carcinoma are eligible for this trial.

Hepatocellular carcinoma is defined as having at least one of the following:

Biopsy proven hepatocellular carcinoma (HCC); or A discrete hepatic tumor(s) as defined by the Barcelona (29) criteria for cirrhotic patients, \>2cm with arterial hypervascularity and venous or delayed phase washout on CT or MRI.

* Patient is within Milan Criteria and "listed" for orthotopic liver transplantation.
* Patients must have a Zubrod performance status of ≤2.
* Patients must have a life expectancy of at least 12 weeks.
* Patients must be 18 years of age or older. Adult patients of all ages, both sexes and all races will be included in this study.
* Patients must be Child-Turcotte-Pugh (CTP) Class A or Class B (≤ 7).
* Female patients within reproductive years may not be, nor become, pregnant during participation in this study. Both male and female patients within reproductive years must agree to use an effective contraceptive method during treatment. Women of childbearing age will be required to undergo a urine or serum pregnancy test to ensure they are not pregnant.
* 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 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 sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the Lahey Hospital and Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.

Exclusion Criteria

* Patients in a "special category" designated the Public Health Service, including patients younger than 18, pregnant women, and prisoners.
* Refractory ascites or ascites that requires paracentesis for management.
* Patients with a solitary lesion greater than 5.0cm in size or more than 2 discrete lesions the largest greater than 3.0 cm in size.
* Known allergy to intravenous iodinated contrast agents unresponsive to prednisone pre-treatment.

Primary outcomes:
measure: Freedom From Progression Over Time
timeFrame: 3, 6 and 12 Months
Secondary outcomes:
measure: Toxicity To Compare Participants With Treatment-related Adverse Events as Assessed by CTCAE
timeFrame: At each treatment, 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment
measure: Number of Participants Who Require Further Interventions Prior to Liver Transplant
timeFrame: 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment
measure: Pathologic Response of Treated Lesion(s)
timeFrame: At time of liver transplant
measure: Radiologic Response of Treat Lesion(s)
timeFrame: Baseline, 3 months post-treatment, 6 months post-treatment, every 3 months thereafter until 2 years post treatment
measure: Quality of Life - Questionnaires Include PIQ-6 and SF-36v2 Health Survey
timeFrame: Baseline, 2 weeks post-treatment, 6 months post-treatment
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
Study officials:
affiliation: Lahey Hospital & Medical Center
name: Francis W Nugent, MD
role: PRINCIPAL_INVESTIGATOR
References: