RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with liver metastases.
OBJECTIVES: * 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Enrollment
27
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.