A Prospective, Randomized Trial Comparing Surgery Versus Radiosurgery for the Treatment of Metastatic Brain Tumors
Introduction: Metastatic brain tumors occur more frequently than primary brain tumors and
occur in approximately 25% of patients who die of cancer each year. The main treatment
goals for patients with brain metastases are the relief of neurological symptoms and
long-term control of the tumors. Glucocorticoids and external beam whole brain radiation
therapy (WBRT) comprise the current standard of care and increase median survival from one
month to three to six months. Patients with three or less tumors (greater than 70% of
patients) also commonly undergo surgery or stereotactic radiosurgery (SRS) with the goal of
lengthening survival. Two prospective randomized trials have shown a significant survival
benefit for patients undergoing surgical resection of single tumors in combination with WBRT
compared to patients receiving WBRT alone. Although there have been no prospective
randomized studies comparing SRS and WBRT to WBRT alone, there have been numerous large
retrospective series reporting a significant survival benefit from SRS. To date, a
prospective randomized trial comparing surgery to SRS has not been reported. Despite the
lack of rigorous data, there are proponents for each of these treatment modalities. Those
in favor of surgery cite the ability to achieve a complete resection in most cases, the
almost immediate relief of symptoms, and the low rate of local recurrence. Those in favor
of SRS cite an equivalent degree of local tumor control compared to surgery, the relative
ease of the one day outpatient procedure, and the ability to treat lesions in deeper brain
structures.
Objectives: We plan to determine in a prospective randomized manner if surgery is superior
to SRS for prolonging survival in patients with one to three surgically accessible brain
tumors.
Study Population: Patients aged twenty one years and older with one to three brain
metastases will be assessed for enrollment in this study.
Design: Patients who meet eligibility criteria will be randomly assigned to undergo either
surgery or SRS for their tumors. Patients will then be followed at regularly scheduled
intervals for the duration of their disease.
Outcome measures: The primary outcome measure will be time of survival following
treatment. Among the secondary outcomes that will be measured over time are tumor
recurrence or progression, neurologic sign or symptom development, functional independence,
steroid and anticonvulsant use, and overall quality of life.
Interventional
Primary Purpose: Treatment
United States: Federal Government
040066
NCT00075166
December 2003
November 2005
Name | Location |
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National Institute of Neurological Disorders and Stroke (NINDS) | Bethesda, Maryland 20892 |