Surgery Versus Stereotactic Radiosurgery in the Treatment of Single Brain Metastasis: A Randomized Trial
|ClinicalTrials.gov Identifier: NCT00460395|
Recruitment Status : Completed
First Posted : April 16, 2007
Last Update Posted : February 24, 2012
- To compare the survival (overall, systemic, and neurological) of patients with single cerebral metastases treated with either conventional surgical resection or stereotactic radiosurgery.
- To compare their rates of recurrence, complications, and their cognitive ability, functional status, and quality of life.
Although surgical resection is a proven and effective treatment for brain metastases in patients with systemic cancer, stereotactic radiosurgery has been suggested to be equally effective and less morbid. Nonrandomized retrospective comparisons have been unable to resolve whether stereotactic radiosurgery is as effective as conventional surgery because of the complexity and variability of the population of patients with cancer and brain metastases. This controversy can only be resolved by a prospective randomized trial comparing these treatment modalities. Patients not randomized will be analyzed as a separate group.
|Condition or disease||Intervention/treatment||Phase|
|Brain Cancer||Procedure: Surgery Procedure: Stereotactic radiosurgery||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Surgery Versus Stereotactic Radiosurgery in the Treatment of Single Brain Metastasis: A Randomized Trial|
|Study Start Date :||January 1998|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460395
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Frederick F. Lang, M.D.||Universtity Of Texas MD Anderson Cancer Center|