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Spots Global Cancer Trial Database for A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer

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Trial Identification

Brief Title: A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer

Official Title: A Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer

Study ID: NCT01522937

Study Description

Brief Summary: This is a Phase II trial to characterize the safety and efficacy of individualized stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment or who have primary hepatocellular carcinoma (HCC).

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Contact Details

Name: Kyle Cuneo, MD

Affiliation: University of Michigan Rogel Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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