This phase II trial tests whether Y-90 segmentectomy (internal radiation) versus stereotactic body radiation therapy (external radiation) is more optimal in treating inoperable liver cancer. Y-90 segmentectomy consists into very tiny radioactive glass beads that can be injected into the liver through the blood vessels supplying the liver. Stereotactic body radiation therapy uses special equipment to position a patient and deliver external radiation to tumors with high precision. This study many help doctors determine which treatment, Y-90 segmentectomy or SBRT, works better in treating liver cancer.
PRIMARY OBJECTIVE: I. Determine feasibility of trial enrollment (enrollment date). SECONDARY OBJECTIVE: I. To assess differences in overall survival, local control, time to intrahepatic progression, time to next treatment, rate of liver transplant, toxicity, and patient reported complications and quality of life. EXPLORATORY OBJECTIVE: I. Compare cumulative cost of treatment-related medical care at 13 months. OUTLINE: Patients will be randomized in 1 of 2 arms. Arm I: Patients undergo SBRT every other day for a total of 5 days over 2 weeks. Arm II: Patients receive Y-90 radioembolization via injection on day 1. After completion of study, patients are followed up at 2, 4, and 12 weeks and then every 3 months for 13 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Ancillary studies
Ancillary studies
Undergo SBRT
Given via injection
Feasibility of enrollment (enrollment rate)
Determine feasibility of trial enrollment for two therapeutic groups.
Time frame: Up to 4 years
Overall survival
Time frame: Death, adjuvant systemic therapy or liver directed therapy to treated lesion, transplant, lost to follow up, or 13 months post-treatment
Time to progression
Time frame: Time of radiographic evidence of treated tumor progression as determined by tumor board review, adjuvant systemic therapy or liver directed therapy to treated lesion, transplant, death, or 13 months post-treatment
Time to intrahepatic progression
Time frame: Time of radiographic intrahepatic progression, adjuvant systemic therapy or liver directed therapy, transplant, death, or 13 months post-treatment
Rate of liver transplant
Time frame: Time of liver transplant, death, or 13 months post-treatment
Rate of non-classic radiation induced liver disease
Defined as a Child-Pugh criteria \>= 2 point increase.
Time frame: Up to 13 months
Rate of patient reported outcome-Common Terminology Criteria for Adverse Events
Time frame: Baseline up to 13 months
Change in patient reported quality of life
Measured by Functional Assessment of Cancer Therapy-Hepatobilliary Cancer compared to baseline.
Time frame: Baseline to 13 months
Time to next treatment
Time frame: Time to next liver directed or non-adjuvant systemic therapy, transplant, or death, assessed up to 13 months
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