This pilot clinical trial studies stereotactic body radiation therapy (SBRT) and transarterial chemoembolization (TACE) in treating patients with liver cancer that cannot be removed by surgery. SBRT is a specialized radiation therapy that delivers a high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumors and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. SBRT may make TACE more beneficial by increasing blood flow to the tumor, which may allow more of the TACE chemotherapy to enter the tumor. Giving SBRT with TACE may work better in treating patients with liver cancer that cannot be removed by surgery.
PRIMARY OBJECTIVES: I. To establish the feasibility of completing SBRT followed by TACE in a 2 day time period. SECONDARY OBJECTIVES: I. To determine acute tumor perfusion changes after SBRT using functional magnetic resonance imaging (MRI) (magnetic resonance \[MR\]-dynamic contrast enhanced \[DCE\]/perfusion weighted imaging \[PWI\], MR-diffusion, blood oxygen level dependent \[BOLD\] sequences). II. To establish safety and tolerability of this regimen. III. To determine overall response rates (using modified Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria), including objective response rate (partial response \[PR\] + complete response \[CR\]) and clinical benefit rate (stable disease \[SD\] + PR + CR) at 1, 3, and 6 months after TACE. IV. To evaluate local control, progression-free survival, and overall survival at 1, 3, 6, 9, and 12 months after a single-dose of SBRT followed by TACE. V. To correlate micro ribonucleic acid (miRNA) biomarkers with response and toxicity. OUTLINE: This is a dose-escalation study of SBRT. Patients undergo SBRT on day 1 and TACE on day 2. After completion of study treatment, patients are followed up at 1-2 weeks and at 1, 3, 6, 9, 12, 18, and 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Correlative studies
Undergo SBRT
Undergo TACE
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Feasibility of SBRT in combination with TACE, measured by the number of patients able to tolerate all study procedures
Determined on the intent-to-treat principle. Any treatment delivery difficulties that arise that could impede successful delivery of this therapy sequence will be evaluated. The capability of the Ohio State University (OSU) system and communication between departments will be analyzed and deemed effective if it facilitates the successful treatment completion of all patients.
Time frame: 2 days
Change in diffusion
Tested by comparing mean values pre- and post-SBRT using a paired t-test. Should there be concern for outliers, the median for each metric will be determined and compared using a corresponding non-parametric procedure.
Time frame: Baseline to day 1 post-SBRT
Change in hypoxia measurements
Tested by comparing mean values pre- and post-SBRT using a paired t-test. Should there be concern for outliers, the median for each metric will be determined and compared using a corresponding non-parametric procedure.
Time frame: Baseline to day 1 post-SBRT
Change in perfusion
Tested by comparing mean values pre- and post-SBRT using a paired t-test. Should there be concern for outliers, the median for each metric will be determined and compared using a corresponding non-parametric procedure.
Time frame: Baseline to day 1 post-SBRT
Incidence of toxicities
Includes measurement of grade 2-5 gastrointestinal symptoms, such as nausea, abdominal pain, hepatitis, enteritis, gastritis, bowel perforation, and fistula, as defined by Common Terminology Criteria for Adverse Events version 4.03.
Time frame: Up to 30 days
Local control
Calculated using standard clinical follow-up with MRI imaging and labs.
Time frame: Up to 12 months
Objective response rate (CR + PR) as measured by modified RECIST criteria version 1
Time frame: Up to 6 months
Overall survival
Calculated using standard clinical follow-up with MRI imaging and labs. Estimated using Kaplan-Meier analysis.
Time frame: Up to 12 months
Progression-free survival
Calculated using standard clinical follow-up with MRI imaging and labs. Estimated using Kaplan-Meier analysis.
Time frame: Up to 12 months
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