This randomized phase II trial studies how well transarterial chemoembolization (TACE) works compared with TACE plus radiation therapy in treating patients with end stage liver disease, liver tumors, or potential liver transplant candidates. TACE involves reaching up to the blood vessel that feeds the tumor through a catheter placed into the groin vessel. Once the physician has defined the vessel going to the tumor, chemotherapy is infused to the tumor and the vessel is blocked, maintaining the chemotherapy for longer time inside the tumor and stopping the blood flow that feeds the tumor. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that delivers radiation to the tumor cells but does not harm normal liver cells. It is not yet known whether TACE is more effective with or without SBRT in treating liver tumors.
PRIMARY OBJECTIVES: I. To determine in patients with stage A to C hepatocellular carcinoma, if stereotactic body radiotherapy after TACE enhanced the response rate of hepatocellular carcinoma (HCC) when compared to TACE alone at 3 months. SECONDARY OBJECTIVES: I. To determine in patients with stage A to C hepatocellular carcinoma, if TACE plus SBRT can achieve a downstaging rate of \>= 30% at 3 and 6 months. II. To determine the rate of grade 3 or 4 adverse events associated with SBRT for liver tumors. III. To determine the rate of local progression after SBRT. (Based on Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) IV. Number of patients who achieve liver transplantation. V. Overall survival. OUTLINE: Patients are randomized to 1 of 2 treatment arms after the first loco-regional therapy with TACE. ARM I: Patients undergo TACE according to institutional standard with doxorubicin-eluting beads. ARM II: Patients undergo TACE as in Arm I and 3 or 5 fractions of SBRT given at least 48 hours apart over 14 days. After completion of study treatment, patients are followed up at 1, 3, and 6 months and then periodically thereafter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Undergo TACE with doxorubicin-eluting beads
Undergo SBRT
Percentage change in gross tumor volume (GTV)
Percentage of tumor response as defined as change in longest diameter of tumor compared to original tumor length
Time frame: Baseline to 3 months
Difference in mean gross tumor volume (GTV), assessed using the RECIST method
Difference in mean GTV from T0M and T3M calculated by a student t-test
Time frame: Baseline to 3 months
Difference in tumor grade
Difference in the grade of tumor (as defined by the RECIST criteria) at T0 and T3 calculated using Chi-square tests.
Time frame: Baseline to 3 months
Rate of downstaging
Rate of downstaging of stage A to C Hepatocellular Carcinoma using TACE plus SBRT when compared to TACE at 3 and 6 months.
Time frame: Up to 6 months
Grade 3 or 4 adverse events associated with liver tumors
Number of grade 3 or 4 adverse events associated with SBRT for liver tumors, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events
Time frame: Up to 1 year
Rate of local progression, based on RECIST criteria
Rate of local disease progression when progression is defined as an estimated increase of \> 20% in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Time frame: Up to 6 months
Liver transplant achievement
Number of patients who achieve liver transplantation
Time frame: Up to 6 months
Survival rate
The number of days from the first day of treatment on study until death of any cause
Time frame: 1 year
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