Status:
ACTIVE_NOT_RECRUITING
Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Malignant Neoplasm in the Brain
Eligibility:
All Genders
4+ years
Phase:
PHASE3
Brief Summary
This randomized phase III trial studies stereotactic radiosurgery to see how well it works compared to clinical observation after surgery in treating patients with brain metastases. Stereotactic radio...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate benefit of post-surgical stereotactic radiosurgery (SRS) on the resection bed in providing 6 month local control (decreasing the risk of local tumor recurrence) whe...
Eligibility Criteria
Inclusion
- Patients must be older than 3 years of age (radiosurgical frames cannot be placed on children younger than age 3).
- Patients must have 3 or fewer newly diagnosed metastatic lesions in the brain with a complete resection of at least one lesion as determined the study neuroradiologist.
- The resection cavity must have a maximum diameter of less than or equal to 4cm. This criteria will be determined by the study radiologist.
- Additional unresected brain metastases (up to 2) must have a maximum diameter of less than or equal to 3 cm.
- Patients must be considered candidates for SRS within 30 days of surgical resection.
- Patients must have a Karnofsky Performance Scores (KPS) of at least 70 at the first post operative visit. Patients under 18 years of age must have a Lansky Performance Score of of at least 70.
- Patients must be able to undergo an MRI scan.
- Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form.
Exclusion
- Patients who have received prior radiation therapy to the brain for any reason.
- There is radiographic evidence of leptomeningeal disease prior to study entry.
- The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.
- For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy).
Key Trial Info
Start Date :
August 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00950001
Start Date
August 13 2009
End Date
April 30 2027
Last Update
August 15 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030