Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Pathologically (histologically or cytologically) proven diagnosis of one of the
following solid tumor malignancies within 5 years prior to registration:
- Non-small cell lung cancer
- Melanoma
- Breast cancer
- Renal cell carcinoma
- Gastrointestinal cancer
- If the original histologic proof of malignancy is greater than 5 years, then
more recent pathologic confirmation (e.g., from a systemic site or brain
metastasis) or unequivocal imaging confirmation of extracranial metastatic
disease (e.g. CT of the chest/abdomen/pelvis, positron emission tomography
[PET]/CT, etc.) is required
- Patients must have at least 1 and up to 8 total intact brain metastases detected on
a contrast-enhanced MRI performed ≤ 21 days prior to registration
- At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion
with a maximum diameter as measured on any orthogonal plane (axial, sagittal,
coronal) of ≥ 1.0 cm and ≤ 3.0 cm
- All brain metastases must be located outside of the brainstem and ≥ 5 mm from the
optic nerves or optic chiasm and ≤ 3.0 cm in maximum dimension
- Note: brainstem metastases per the MRI within 21 days of registration are an
exclusion criterion; however, if the MRI used for treatment planning performed
within 7 days of SRS/FSRS reveals a brainstem metastasis, the patient remains
eligible if the patient is considered an appropriate radiosurgery candidate per
the local investigator
- Patients must have a diagnosis-specific graded prognostic assessment ≥ 1.5
- No more than 2 lesions planned for resection if clinically indicated
- No known leptomeningeal disease (LMD)
- Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as
positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or
clinical evidence of leptomeningeal involvement. Patients with leptomeningeal
symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be
considered to have LMD even in the absence of positive CSF cytology. In
contrast, an asymptomatic or minimally symptomatic patient with mild or
nonspecific leptomeningeal enhancement (MRI) would not be considered to have
LMD. In that patient, CSF sampling is not required to formally exclude LMD, but
can be performed at the investigator's discretion based on level of clinical
suspicion
- Age ≥ 18 years
- Karnofsky performance status (KPS) ≥ 60
- Negative urine or serum pregnancy test (in persons of childbearing potential) within
14 days prior to registration. Childbearing potential is defined as any person who
has experienced menarche and who has not undergone surgical sterilization
(hysterectomy or bilateral oophorectomy) or who is not postmenopausal
- No prior radiotherapy to the brain (partial or whole brain irradiation, SRS, FSRS,
or prophylactic cranial irradiation [PCI])
- New York Heart Association Functional Classification II or better (NYHA Functional
Classification III/IV are not eligible) (Note: Patients with known history or
current symptoms of cardiac disease, or history of treatment with cardiotoxic
agents, should have a clinical risk assessment of cardiac function using the New
York Heart Association Functional Classification)
- No active infection currently requiring intravenous (IV) antibiotic management
- No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- No chronic obstructive pulmonary disease exacerbation or other acute respiratory
illness precluding study therapy