Stereotactic Radiosurgery in Treating Patients With Liver Metastases
|ClinicalTrials.gov Identifier: NCT00547677|
Recruitment Status : Unknown
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : October 22, 2007
Last Update Posted : February 9, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific||Radiation: stereotactic radiosurgery||Phase 1|
- 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 (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Official Title:||A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)|
|Study Start Date :||July 2004|
|Estimated Primary Completion Date :||December 2007|
- Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|