Surgery Versus Stereotactic Radiosurgery in the Treatment of Single Brain Metastasis: A Randomized Trial

Completed · Phase 3

Conditions studied: Brain Cancer

In brief

Study Objectives: * 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.

Key facts

Study ID

NCT00460395

Run by

M.D. Anderson Cancer Center

People needed

64

Starts

1998-01-01

Expected to finish

2005-12-01

Last updated by the study team

2012-02-24

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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