Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00950001 : Resection Bed Post-Surgical Stereotactic Radiosurgery (SRS)
PhasePhase 3
AgesMin: 3 Years Max: N/A
Eligibility
Inclusion Criteria:

1. Patients must be older than 3 years of age (radiosurgical frames cannot be placed on
children younger than age 3).

2. 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.

3. The resection cavity must have a maximum diameter of less than or equal to 4cm. This
criteria will be determined by the study radiologist.

4. Additional unresected brain metastases (up to 2) must have a maximum diameter of less
than or equal to 3 cm.

5. Patients must be considered candidates for SRS within 30 days of surgical resection.

6. 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.

7. Patients must be able to undergo an MRI scan.

8. Patients must agree to randomization as documented by signing the Institutional
Review Board (IRB) approved consent form.

Exclusion Criteria:

1. Patients who have received prior radiation therapy to the brain for any reason.

2. There is radiographic evidence of leptomeningeal disease prior to study entry.

3. The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.

4. For females, if they are pregnant or breast-feeding (The exclusion is made because
gadolinium may be teratogenic in pregnancy).
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00950001      |      Link to official Clinicaltrials.gov listing
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