This phase I trial identifies the side effects of Y-90 selective internal radiation therapy (SIRT) and stereotactic body radiation therapy (SBRT) in treating patients with liver cancer that cannot be removed by surgery (unresectable). SIRT is a technique where radiation is internally delivered to a tumor. In SIRT, small radioactive beads are deposited in the liver through a large blood vessel (hepatic artery). SIRT that uses the radioactive material Yttrium-90 is called Y-90 SIRT. SBRT is a technique where radiation is externally delivered to a tumor. In SBRT, a machine produces a beam of radiation that targets the tumor from outside the body. Giving Y-90 SIRT and SBRT may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04518748.
Locations matching your search criteria
United States
Michigan
Ann Arbor
University of Michigan Rogel Cancer CenterStatus: Active
Contact: Kyle C. Cuneo
Phone: 734-936-4300
PRIMARY OBJECTIVE:
I. To obtain preliminary estimates of the toxicity of standard SIRT plus standard SBRT, and compare the toxicity to matched historical control patients treated with standard SIRT.
SECONDARY OBJECTIVES:
I. To obtain preliminary estimates of the efficacy of standard SIRT+ standard SBRT, and compare the efficacy to matched historical control patients treated with standard SIRT alone.
II. To characterize the association between lesion absorbed dose and freedom from local progression in patients who receive Y90 + SBRT and Y90 alone.
III. To characterize the association between liver absorbed dose and liver toxicity in patients who receive Y90 + SBRT and Y90 alone.
EXPLORATORY OBJECTIVES:
I. To obtain patient imaging data to train/test deep learning based tools that we will develop for lesion and normal organ segmentation.
II. To obtain patient imaging data to train/test deep learning based tools that we will develop for voxel-level absorbed dose estimation.
III. To measure serum and plasma cytokines before and after treatment.
OUTLINE:
Patients receive standard of care Y-90 via SIRT on day 0. Within 6 weeks after Y-90 SIRT, patients undergo standard of care SBRT for a total of 3-5 fractions over 1-2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo single-photon emission computed tomography (SPECT)/computed tomography (CT) and chest CT during pre-study, diagnostic CT or magnetic resonance imaging (MRI) during pre-study and follow up, positron emission tomography (PET)/CT on study, and collection of blood samples on study and during follow up. Patients may undergo optional perfusion MRI during pre-study and on study.
After completion of study treatment, patients are followed up at 1, 3, 6 and 12 months and then optionally every 6 months for up to 24 months.
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorKyle C. Cuneo
