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.]

NCT01705548 : Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Pathologic proven diagnosis of solid tumor malignancy

- Solitary brain metastasis or brain metastasis resection cavity with maximal diameter =
3 cm (or = 14 cc.) and = 6 cm (or = 113 cc.)

- Mini Mental Status Exam (MMSE) = 18 prior to study entry

- Recursive partitioning analysis (RPA) class I-II/ Karnofsky Performance status (KPS) =
70%

Exclusion Criteria:

- Prior stereotactic radiosurgery (SRS) to adjacent lesion such that planning target
volume would have received more than 12 Gy

- RPA class III (KPS < 70%)

- Brain metastasis or resection cavity volume < 3 cm or > 6 cm

- Radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors,
leukemias, or lymphomas) or unknown tumor histologies

- Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation)

- Evidence of leptomeningeal disease by magnetic resonance imaging (MRI) and/or
cerebrospinal fluid (CSF) cytology

- Current pregnancy

- More than 8 weeks between resection and radiosurgical procedure

- Metastases to brain stem, midbrain, pons, or medulla or within 5 mm of the optic
apparatus (optic nerves and chiasm)

- Inability to undergo MRI evaluation for treatment planning and follow-up
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01705548      |      Link to official Clinicaltrials.gov listing
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