A Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
The trial endpoints are toxicity, survival and progression-free survival. DCE-MRI and plasma
biomarkers will also be collected to explore their use as tools for treatment
individualization in future trials. During the current trial, an indicator of liver
function, indocyanine green (ICG), will be used to identify during treatment patients who
are at excess risk for radiation-induced liver disease (RILD) so that their radiation dose
may be reduced. The model used for individualization will be updated as trial data accrue,
so this is an adaptive trial of an individualized therapy. The planned accrual is seventy
(70) evaluable patients over three years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor measure rates
Tumor size will be measured every 2 months following treatment to assess for shrinkage, stability of size, or increasing size. Adverse events will also be monitored every 2 months to assess for safety.
Mary Feng, MD
University of Michigan Cancer Center
United States: Institutional Review Board
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|