Status:
COMPLETED
Surgery Versus Radiosurgery to Treat Metastatic Brain Tumors
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Brain Neoplasms
Neoplasm Metastasis
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
This study will compare the effectiveness of craniotomy to that of stereotactic surgery (SRS) for the treatment of metastatic brain tumors - tumors that first develop elsewhere in the body and then tr...
Detailed Description
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...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients must:
- be 21 years of age or older.
- have a histologically confirmed primary malignancy.
- be able to undergo an MRI scan of the brain.
- have one to three intraparenchymal brain metastases as identified on a brain MRI scan with intravenous contrast.
- have contrast enhancing tumor(s) that are well circumscribed and less than or equal to 4.0 cm in any dimension.
- be appropriate for either procedure as determined by both a neurosurgeon and a radiation oncologist.
- EXCLUSION CRITERIA:
- Patients must not:
- have tumor(s) in the midbrain, pons, or medulla - patients undergoing surgical resections in these areas are highly likely to develop significant neurological deficits or death.
- have tumors within 10 millimeters of the optic apparatus (nerves and chiasm) or the area postrema - patients undergoing SRS to these areas are at significant risk of developing permanent blindness or intractable nausea.
- be poor operative candidates from an anesthetic point of view secondary to other major medical illnesses - the risk of undergoing general anesthesia outweighs the potential benefit of undergoing surgical resection of a brain metastasis.
- have a coagulopathy demonstrated by an abnormal prothrombin time, activated partial thromboplastin time, or thrombocytopenia (platelet count less that 150,000 platelets/mm3) - the risk of developing uncontrollable intra-operatively bleeding outweighs the potential benefit of undergoing surgical resection of a brain metastasis.
- have radiographic or cerebrospinal fluid specimen evidence of widespread leptomeningeal metastasis - neither surgery nor SRS is a useful treatment modality for this condition.
- significant psychiatric impairments which, in the opinion of the investigators, will interfere with the proper administration or completion of the protocol - self explanatory.
- acute or untreated infections (viral, bacterial or fungal) - patients with active infections are highly likely to have spread of their infections to the brain as a result of a craniotomy.
- be pregnant at the time of the randomized treatment - general anesthesia and surgery may subject the fetus to unacceptable risks. Also, the NIH does not offer full obstetrical services in the event that medical care to the mother and/or fetus is required. Pregnant women presenting with brain metastases will be referred to facilities offering OB/GYN services.
- be prisoners or other institutionalized individuals - these individuals are at risk of being susceptible to undue influences to participate in a research protocol against their free will.
- have a diagnosis of germ cell tumor, lymphoma or small cell lung cancer - these tumors are highly radiosensitive and should therefore be treated with radiation.
- have any of the following: aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or auto defibrillator, cochlear implant, ocular foreign body or implant \[e.g. metal shavings, retinal clips\], or insulin pump as these items would be contra-indications to undergoing an MRI scan.
- have an allergy to iodine or shellfish or have previously had an allergic reaction to iodinated-contrast agents as this is a contra-indication to undergoing a contrast enhanced CT of the brain - a contrast enhanced CT of the brain is required for the planning of SRS.
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00075166
Start Date
December 1 2003
End Date
November 1 2005
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892