Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases
- Conditions
- Metastatic Malignant Neoplasm in the Brain
- Registration Number
- NCT00950001
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria:<br><br> 1. Patients must be older than 3 years of age (radiosurgical frames cannot be placed on<br> children younger than age 3).<br><br> 2. Patients must have 3 or fewer newly diagnosed metastatic lesions in the brain with a<br> complete resection of at least one lesion as determined the study neuroradiologist.<br><br> 3. The resection cavity must have a maximum diameter of less than or equal to 4cm. This<br> criteria will be determined by the study radiologist.<br><br> 4. Additional unresected brain metastases (up to 2) must have a maximum diameter of<br> less than or equal to 3 cm.<br><br> 5. Patients must be considered candidates for SRS within 30 days of surgical resection.<br><br> 6. Patients must have a Karnofsky Performance Scores (KPS) of at least 70 at the first<br> post operative visit. Patients under 18 years of age must have a Lansky Performance<br> Score of of at least 70.<br><br> 7. Patients must be able to undergo an MRI scan.<br><br> 8. Patients must agree to randomization as documented by signing the Institutional<br> Review Board (IRB) approved consent form.<br><br>Exclusion Criteria:<br><br> 1. Patients who have received prior radiation therapy to the brain for any reason.<br><br> 2. There is radiographic evidence of leptomeningeal disease prior to study entry.<br><br> 3. The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple<br> myeloma.<br><br> 4. For females, if they are pregnant or breast-feeding (The exclusion is made because<br> gadolinium may be teratogenic in pregnancy).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to local recurrence
- Secondary Outcome Measures
Name Time Method Overall survival;Development of distant brain metastases;Incidence of complications related to treatment;Proportion of patients experiencing neurological complications;Proportion of complications resulting in prolongation of hospital stay;Time to first neurological complication