NCT01522937

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cancer
• Hepatocellular Cancer

Interventions

Type	Name	Description
RADIATION	individualized Stereotactic Body Radiation Therapy (SBRT)	The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment.

Timeline

• Start date: 2009-10-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2012-02-01
• Last updated: 2017-03-09
• Results posted: 2017-03-09

Locations

1 site across 1 country: United States