This phase II trial studies how well transarterial chemoembolization (TACE) and stereotactic body radiation therapy (SBRT) work in treating patients with liver cancer. TACE is a procedure where an interventional radiologist selectively cuts off the blood supply to a tumor. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving TACE and SBRT may work better in treating patients with liver cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02513199.
PRIMARY OBJECTIVES:
I. To determine the objective response rate up to 1 year in patients with hepatocellular carcinoma (HCC) treated with combination TACE and SBRT.
SECONDARY OBJECTIVES:
I. To determine the time to progression (TTP) of the treated lesion.
II. To determine the overall survival (OS) of patients as defined from completion of treatment until death.
III. To determine the progression free survival (PFS) of patients as defined from the completion of treatment until disease progression in the treated lesion, liver, or distant metastases.
IV. To determine the tolerability and toxicity of combination TACE and SBRT in this population.
OUTLINE:
Patients undergo TACE at baseline and 1 month. After 2 weeks, patients undergo SBRT every other day for 5 treatments in the absence of disease progression or unexpected toxicity.
After completion of study treatment, patients are follow up every 3 months for up to 14 months.
Lead OrganizationIcahn School of Medicine at Mount Sinai
Principal InvestigatorMichael H. Buckstein
