Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases
Running, not enrolling · Phase 3
Conditions studied: Metastatic Malignant Neoplasm in the Brain
In brief
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 radiosurgery, a type of radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Key facts
- Study ID
- NCT00950001
- Run by
- M.D. Anderson Cancer Center
- People needed
- 132
- Starts
- 2009-08-13
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2026-02-20
Who can join
Age: 4 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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