N/A
N=24
Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases
Malignant Neoplasm Brain
Bottom Line
View on ClinicalTrials.gov: NCT02514915 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Local Control Rate (LCR) at 6 Months — 0.817 proportion of patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stereotactic Radiosurgery (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Christopher Wilke
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Control Rate (LCR) at 6 Months |
0.817 | — |
| PRIMARY Local Control Rate (LCR) at 12 Months |
0.817 | — |
| PRIMARY Local Control Rate (LCR) at 24 Months |
0.749 | — |
| SECONDARY 6-month Overall Survival (OS) |
0.708 | — |
| SECONDARY 12-month Overall Survival (OS) |
0.625 | — |
| SECONDARY 24-month Overall Survival (OS) |
0.500 | — |
| SECONDARY Distant Intracranial Failure |
0.502 | — |
| SECONDARY Distant Intracranial Failure |
0.502 | — |
| SECONDARY Distant Intracranial Failure |
0.502 | — |
| SECONDARY Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) |
150.1484545 | — |
| SECONDARY Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) |
150.1484545 | — |
| SECONDARY Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) |
150.1484545 | — |
| SECONDARY Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) |
150.1484545 | — |
| SECONDARY Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) |
150.1484545 | — |
| SECONDARY Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) |
150.1484545 | — |
Summary
The primary goal of this research study is to determine the efficacy of giving pre-operative radiosurgery to patients pending resection of a brain metastasis.
Eligibility Criteria
Inclusion Criteria
- Life expectancy of at least 12 weeks
- Karnofsky performance status of at least 50
- No contraindications to MRI scanning with intravenous contrast.
- MRI scan consistent with brain metastasis as per radiology report.
- Target lesion must measure at least 15 mm in at least one dimension, and no more than 4 cm in any dimension.
- Patients must have an extra-cranial primary tumor diagnosis.
- Patients will have no more than 4 distinct lesions within the brain. At least 1 lesion has been recommended for surgical removal based on size, symptomology, or regional mass effect on the brain.
- Additional lesions will each be treated with stereotactic radiosurgery.
- Patients with a documented symptomatic lesion size smaller than 3cm requiring clinical surgical resection
- Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
Exclusion Criteria
- Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor. Moribund status or status epilepticus.
- Supratentorial mass effect with greater than 5 mm of midline shift or hydrocephalus. Infratentorial mass effect with fourth ventricle effacement or hydrocephalus.
- More than four additional diagnosed brain metastases.
- Contraindication to general anesthesia.
- Adjacent tumor location to optic apparatus or brainstem, precluding achievement of meaningful dose with SRS.
- Primary brain tumor.
- Contraindication to MRI scans or intravenous contrast.
- Pregnant and breast-feeding females.
Data sourced from ClinicalTrials.gov (NCT02514915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.