A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)
- To determine the maximum tolerated dose of fractionated stereotactic radiosurgery in
patients with hepatic metastases.
- To determine the dose-limiting toxicity of stereotactic radiosurgery in these patients.
- To assess the tumor response in these patients.
OUTLINE: This is a multicenter study.
Patients receive 3-5 fractions of stereotactic radiosurgery over 14 days in the absence of
disease progression or unacceptable toxicity.
Cohorts of 9-13 patients receive escalating doses of stereotactic radiosurgery until 60 Gy
is reached or the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which > 33% of patients experience dose-limiting toxicity.
After completion of study therapy, patients are followed at 6 weeks, every 3 months for 1
year, every 6 months for 2 years, and then annually for 2 years.
Allocation: Non-Randomized, Primary Purpose: Treatment
Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0
Robert D. Timmerman, MD
Simmons Cancer Center
United States: Federal Government
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|