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N/A N=24 Treatment

Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases

Malignant Neoplasm Brain

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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