Stereotactic Radiosurgery in Treating Patients With Liver Metastases
Recruitment status was: Active, not recruiting
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.
Unspecified Adult Solid Tumor, Protocol Specific
Radiation: stereotactic radiosurgery
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)|
- Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
|Study Start Date:||July 2004|
|Estimated Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547677
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|Study Chair:||Robert D. Timmerman, MD||Simmons Cancer Center|