A Phase 1 Study of Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.
Summary
This study will investigate the combination of Ytrium-90 (Y-90) Selective Internal Radiation Therapy (SIRT) followed by Stereotactic Body Radiation Therapy (SBRT). Y-90 SIRT alone or SBRT alone are standard procedures used in the treatment of liver cancer. This study will assess the combination of Y-90 SIRT and SBRT and obtain preliminary information about the side effects and safety of the combination therapy. Additionally, this is the first time that Y-90 PET-CT imaging will be included in planning for SBRT.
Detailed description
Selective Internal Radiation Therapy (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. Stereotactic Body Radiation Therapy (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. After receiving Y-90 SIRT, participants will be evaluated to estimate how much radiation was absorbed by their tumors during Y-90 SIRT. Y-90 PET-CT imaging will be used to help plan SBRT, which will target areas of tumors that did not receive as much radiation as expected during Y-90 SIRT. Updated to add 5 patients to enrollment goal to achieve desired number of evaluable patients Since patients treated with Y-90 for any liver malignancy can benefit from the Y-90+SBRT combined treatment approach we have decided to open up the protocol to all eligible patients and not HCC alone.
Arms & interventions
- DrugYttrium-90
Radioactive isotope Y-90 at day 0, administered by selective internal radiation therapy (SIRT)
- DeviceSelective Internal Radiation Therapy
SIRT at day 0, to administer Yttrium-90 (Y-90) Theraspheres
- RadiationStereotactic Body Radiation Therapy
3-5 fractions over 1-2 weeks, after Y-90 SIRT
- Diagnostic TestPET/CT
Within 3 hours of completing Y-90 SIRT
- DeviceTherasphere
Glass microspheres containing Y-90, administered at day 0 by SIRT
Outcome measures
Primary
Change in Child-Turcotte-Pugh (CTP) score >= 2 points from baseline
The primary safety endpoint is the binary indicator for a CTP increase of 2 or more points within 6 months and relative to pre-SBRT baseline. An increase of 2 or more points indicates clinically significant liver decompensation.
Time frame: Up to 6 months after SBRT
Incidence of toxicities of grade 3 or higher
A secondary safety endpoint is grade 3+ toxicity within 6 months relative to pre-SBRT baseline. Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Up to 6 months after SBRT
Number of patients with a change in albumin + bilirubin (ALBI) level of >= 0.5
A secondary safety endpoint is the binary indicator for an increase in ALBI within 6 months relative to pre-SBRT baseline of 0.5 or greater.
Time frame: Up to 6 months after SBRT
Secondary
Freedom from local progression (FFLP) at the lesion level
Time frame: Until progression or last surveillance scan at approximately 24 months after SBRT
Freedom from local progression (FFLP) at patient level
Time frame: Until progression or last surveillance scan at approximately 24 months after SBRT
Response rate
Time frame: Up to 6 months after SBRT
Overall survival
Time frame: Until death from any cause, or until patient's last follow-up visit, or until study stops; up to approximately 5 years.
Eligibility criteria
Study locations (1)
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
References
- Lu Z, Polan DF, Wei L, Aryal MP, Fitzpatrick K, Wang C, Cuneo KC, Evans JR, Roseland ME, Gemmete JJ, Christensen JA, Kapoor BS, Mikell JK, Cao Y, Mok GSP, Dewaraja YK. PET/CT-Based Absorbed Dose Maps in 90Y Selective Internal Radiation Therapy Correlate with Spatial Changes in Liver Function Derived from Dynamic MRI. J Nucl Med. 2024 Aug 1;65(8):1224-1230. doi: 10.2967/jnumed.124.267421.(PubMed)