Clinical Trial Details
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NCT02798029 : Frameless Fractionated Stereotactic Radiation Therapy (FSRT) for Brain Mets Study
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

1. All patients with 1-4 metastatic brain lesions who are considered eligible for
single-fraction, frame-based SRS, who are unable or unwilling to undergo frame-based

2. Greater than or equal to 18 years of age

3. One to 4 untreated metastatic brain lesions

4. Each brain lesion must be less than or equal to 5 cm in diameter and not an optimal
surgical candidate

5. Patient must be able have an magnetic resonance imaging (MRI) of the brain for
treatment planning

6. Histologic confirmation of malignancy

7. For patients of childbearing potential, non-pregnant state, confirmed by negative
serum or urine beta-human chorionic gonadotropin (HCG) within (7) days of planned
radiation treatment

8. Glomerular filtration rate (GFR) adequate for intravenous (IV) contrast delivery for

9. No concurrent chemotherapy

10. Patient may have had prior therapy for brain metastasis, including radiosurgery and
surgical resection however must have completed prior resection and radiosurgery at
least 90 days before enrollment and not received further active treatment.

Exclusion Criteria:

1. Less than 18 years old

2. Five or more metastatic brain lesions

3. Brain lesion(s) greater than 5 cm in diameter

4. Lesion(s) involving the brainstem, optic chiasm or optic nerve(s)

5. Patients unable to have IV contrast for computed tomography (CT) and MRI imaging

6. Patient unable to have an MRI of the brain

7. Patients willing to be treated with frame-based Gamma Knife SRS at MD Anderson main
campus or MD Anderson at The Woodlands

8. Positive pregnant status confirmed by serum or urine pregnancy test

9. Primary small cell lung cancer, myeloma, lymphoma, leukemia, or other histologies not
optimally treated with SRS

10. Patients currently receiving chemotherapy/biologic/immunotherapy as these need to be
held during FFSRT

11. Prior whole brain radiotherapy or conventional external beam radiotherapy.
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