NCT04545814

Analyzing Preoperative Stereotactic Radiosurgery With Gamma Knife Icon for Brain Metastases

Completed NA Results posted Last updated 24 March 2026

What this trial tests

NA trial testing Stereotactic Radiosurgery in Brain Metastases in 11 participants. Completed in 22 August 2024.

Timeline

15 January 2021

Primary endpoint
22 August 2024

22 August 2024

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	15 January 2021
Primary completion	22 August 2024
Estimated completion	22 August 2024
Sites	1 location across United States

Drugs / interventions tested

• Stereotactic Radiosurgery
• Surgical Resection
• Magnetic Resonance Imaging

Conditions studied

• Brain Metastases — all drugs for Brain Metastases →

Sponsor

Medical College of Wisconsin

Who can join

18 and older, any sex, with Brain Metastases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Number of Subjects Undergoing Resection Following SRS. Primary · 10 days following SRS

All subjects undergoing resection following SRS will be documented.

Group	Value	95% CI
Stereotactic Radiosurgery	11

The Number of Subjects With no Identifiable Disease Following Resection. Primary · 20 months

Identifiable disease will be determined by post-treatment MRI of the brain.

Group	Value	95% CI
Stereotactic Radiosurgery	4

The Number of Subjects Achieving CNS Progression-free Survival. Secondary · 6, 12 and 18 months

Progression/progressive disease for this outcome measure was assessed at the index lesion using the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. Lesions must be contrast-enhancing on T1-weighted MRI, with at least one dimension ≥ 10 mm and visible on ≥ 2 axial slices. Progression is defined as a ≥ 20% increase in the sum of diameters (with a ≥ 5 mm absolute increase) or new lesions. Subjects will be evaluated at six, 12 and 18 months.

6 months

Group	Value	95% CI
Stereotactic Radiosurgery	8

12 months

Group	Value	95% CI
Stereotactic Radiosurgery	8

18 months

Group	Value	95% CI
Stereotactic Radiosurgery	7

The Number of Subjects Achieving Overall Survival. Secondary · 6, 12 and 18 months

The number of subjects alive at six, 12 and 18 months following surgical resection.

6 months

Group	Value	95% CI
Stereotactic Radiosurgery	10

12 months

Group	Value	95% CI
Stereotactic Radiosurgery	8

18 months

Group	Value	95% CI
Stereotactic Radiosurgery	7

The Number of Subjects With Leptomeningeal Carcinomatosis Using Preoperative SRS. Secondary · Two years

The number of subjects with this diagnosis will be documented.

Group	Value	95% CI
Stereotactic Radiosurgery	1

The Number of Subjects With Radiation Necrosis. Secondary · Two years

Radiation necrosis will be determined by radiographic appearance on posttreatment MRI. The number of patients with radiation necrosis will be documented.

Group	Value	95% CI
Stereotactic Radiosurgery	0

The Number of Subjects Reporting a High Quality of Life. Secondary · Every 3 months until two years; 3, 6, 9, 12, 15, and 18 months reported

Quality of life will be measured by the MD Anderson Symptom Inventory for brain tumor (MDASI-BT). The MDASI assesses the severity of symptoms at their worst in the last. 24 hours on a 0-10 numeric rating scale (NRS), with 0 being "not present" and 10 being "as bad as you can imagine." Health-related quality of life was assessed using the EQ-5D-5L instrument. While not identical to the MDASI, the EQ-5D-5L has been shown to correlate strongly with symptom burden and overall quality-of-life measures commonly used in oncology populations and was used here as a pragmatic surrogate for global quali

3 months

Group	Value	95% CI
Stereotactic Radiosurgery	3

6 months

Group	Value	95% CI
Stereotactic Radiosurgery	3

9 months

Group	Value	95% CI
Stereotactic Radiosurgery	4

12 months

Group	Value	95% CI
Stereotactic Radiosurgery	3

15 months

Group	Value	95% CI
Stereotactic Radiosurgery	3

18 months

Group	Value	95% CI
Stereotactic Radiosurgery	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were collected for 1 month ±7 days from radiosurgery, Up to 2 months 2 days. All-Cause Mortality was assessed up to 18 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Stereotactic Radiosurgery

Serious: 0/11 (0%)

Deaths: 0/11

Surgical Resection

Serious: 0/11 (0%)

Deaths: 4/11

Other adverse events (12 terms — click to expand)

Reaction	System	Stereotactic Radiosurgery	Surgical Resection
Alanine aminotransferase increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—
Acute kidney injury	Renal and urinary disorders	—	—
Electrocardiogram QT corrected interval prolonged	Investigations	—	—
Sinus tachycardia	Cardiac disorders	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Fatigue	General disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Hematuria	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT04545814 adverse events section.

Sponsor's own description

This is a single-arm, single-center pilot study in which 10 patients with one to four brain metastases diagnosed on brain magnetic resonance imaging (MRI) within the past 30 days will be evaluated for study eligibility and enrolled as appropriate.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neoadjuvant stereotactic radiotherapy for brain metastasis: a review of ongoing clinical trials.
   Amirkhani N, Saraee E, Zeinalizadeh M, Fiorentino A, et al · · 2025 · PMID 40721673 · DOI 10.1007/s12672-025-03290-9
2. Symptomatic radionecrosis after postoperative but not preoperative stereotactic radiosurgery in a single patient: illustrative case.
   Laurin BJ, Straza M, Noid G, Connelly JM, et al · · 2023 · PMID 37870754 · DOI 10.3171/case23392