Status:
COMPLETED
Surgery Versus Stereotactic Radiosurgery in the Treatment of Single Brain Metastasis: A Randomized Trial
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Brain Cancer
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
Study Objectives: * To compare the survival (overall, systemic, and neurological) of patients with single cerebral metastases treated with either conventional surgical resection or stereotactic radio...
Detailed Description
Eligible patients will be randomized to either conventional surgery or stereotactic radiosurgery, or participate as a separate group of the study, if they refuse randomization. At the time of diagnosi...
Eligibility Criteria
Inclusion
- Age 16 years and older;
- Documented diagnosis of cancer within 5 years (except for patients with unknown primary);
- Newly diagnosed single brain metastases as determined by MRI;
- Candidacy for both conventional surgical resection as well as stereotactic radiosurgery;
- Karnofsky Performance Score \> 70;
- Life expectancy of at least 4 months;
- Signature of the approved consent form.
Exclusion
- Prior radiation therapy to the brain;
- Evidence of leptomeningeal disease;
- Need for immediate treatment to prevent neurological deterioration;
- Extremely radiosensitive primary tumor;
- Prior radioiodine (for thyroid metastases);
- Pregnancy or lactation.
Key Trial Info
Start Date :
January 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00460395
Start Date
January 1 1998
End Date
December 1 2005
Last Update
February 24 2012
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030