Trial Outcomes & Findings for Analyzing Preoperative Stereotactic Radiosurgery With Gamma Knife Icon for Brain Metastases (NCT NCT04545814)
NCT ID: NCT04545814
Last Updated: 2026-03-24
Results Overview
All subjects undergoing resection following SRS will be documented.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
10 days following SRS
Results posted on
2026-03-24
Participant Flow
Participant milestones
| Measure |
Stereotactic Radiosurgery
SRS will be delivered utilizing gamma knife or linear accelerator-based techniques.
Stereotactic Radiosurgery: Maximum Tumor Diameter ≤ 2 cm = 20-24 Gy; Maximum Tumor Diameter 2.1-3.0 cm = 18 Gy; Maximum Tumor Diameter 3.1-5.0 cm = 15 Gy
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
20-24 Gy
|
5
|
|
Overall Study
18 Gy
|
7
|
|
Overall Study
15 Gy
|
2
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analyzing Preoperative Stereotactic Radiosurgery With Gamma Knife Icon for Brain Metastases
Baseline characteristics by cohort
| Measure |
Stereotactic Radiosurgery
n=11 Participants
SRS will be delivered utilizing gamma knife or linear accelerator-based techniques.
Stereotactic Radiosurgery: Maximum Tumor Diameter ≤ 2 cm = 20-24 Gy; Maximum Tumor Diameter 2.1-3.0 cm = 18 Gy; Maximum Tumor Diameter 3.1-5.0 cm = 15 Gy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=138 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=138 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=138 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=138 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=138 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=138 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=138 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=138 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=138 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=138 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=138 Participants
|
PRIMARY outcome
Timeframe: 10 days following SRSAll subjects undergoing resection following SRS will be documented.
Outcome measures
| Measure |
Stereotactic Radiosurgery
n=11 Participants
SRS will be delivered utilizing gamma knife or linear accelerator-based techniques.
Stereotactic Radiosurgery: Maximum Tumor Diameter ≤ 2 cm = 20-24 Gy; Maximum Tumor Diameter 2.1-3.0 cm = 18 Gy; Maximum Tumor Diameter 3.1-5.0 cm = 15 Gy
Surgical Resection: Enrolled patients will receive GK-SRS to all metastases followed by surgical resection of resectable metastases within one to10 days following GK-SRS.
Magnetic Resonance Imaging: Following surgical resection, the patient will enter a standard pattern of surveillance (brain MRI every three months for two years).
|
|---|---|
|
The Number of Subjects Undergoing Resection Following SRS.
|
11 Participants
|
PRIMARY outcome
Timeframe: 20 monthsIdentifiable disease will be determined by post-treatment MRI of the brain.
Outcome measures
| Measure |
Stereotactic Radiosurgery
n=11 Participants
SRS will be delivered utilizing gamma knife or linear accelerator-based techniques.
Stereotactic Radiosurgery: Maximum Tumor Diameter ≤ 2 cm = 20-24 Gy; Maximum Tumor Diameter 2.1-3.0 cm = 18 Gy; Maximum Tumor Diameter 3.1-5.0 cm = 15 Gy
Surgical Resection: Enrolled patients will receive GK-SRS to all metastases followed by surgical resection of resectable metastases within one to10 days following GK-SRS.
Magnetic Resonance Imaging: Following surgical resection, the patient will enter a standard pattern of surveillance (brain MRI every three months for two years).
|
|---|---|
|
The Number of Subjects With no Identifiable Disease Following Resection.
|
4 Participants
|
SECONDARY outcome
Timeframe: 6, 12 and 18 monthsProgression/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.
Outcome measures
| Measure |
Stereotactic Radiosurgery
n=11 Participants
SRS will be delivered utilizing gamma knife or linear accelerator-based techniques.
Stereotactic Radiosurgery: Maximum Tumor Diameter ≤ 2 cm = 20-24 Gy; Maximum Tumor Diameter 2.1-3.0 cm = 18 Gy; Maximum Tumor Diameter 3.1-5.0 cm = 15 Gy
Surgical Resection: Enrolled patients will receive GK-SRS to all metastases followed by surgical resection of resectable metastases within one to10 days following GK-SRS.
Magnetic Resonance Imaging: Following surgical resection, the patient will enter a standard pattern of surveillance (brain MRI every three months for two years).
|
|---|---|
|
The Number of Subjects Achieving CNS Progression-free Survival.
6 months
|
8 Participants
|
|
The Number of Subjects Achieving CNS Progression-free Survival.
12 months
|
8 Participants
|
|
The Number of Subjects Achieving CNS Progression-free Survival.
18 months
|
7 Participants
|
SECONDARY outcome
Timeframe: 6, 12 and 18 monthsThe number of subjects alive at six, 12 and 18 months following surgical resection.
Outcome measures
| Measure |
Stereotactic Radiosurgery
n=11 Participants
SRS will be delivered utilizing gamma knife or linear accelerator-based techniques.
Stereotactic Radiosurgery: Maximum Tumor Diameter ≤ 2 cm = 20-24 Gy; Maximum Tumor Diameter 2.1-3.0 cm = 18 Gy; Maximum Tumor Diameter 3.1-5.0 cm = 15 Gy
Surgical Resection: Enrolled patients will receive GK-SRS to all metastases followed by surgical resection of resectable metastases within one to10 days following GK-SRS.
Magnetic Resonance Imaging: Following surgical resection, the patient will enter a standard pattern of surveillance (brain MRI every three months for two years).
|
|---|---|
|
The Number of Subjects Achieving Overall Survival.
6 months
|
10 Participants
|
|
The Number of Subjects Achieving Overall Survival.
12 months
|
8 Participants
|
|
The Number of Subjects Achieving Overall Survival.
18 months
|
7 Participants
|
SECONDARY outcome
Timeframe: Two yearsThe number of subjects with this diagnosis will be documented.
Outcome measures
| Measure |
Stereotactic Radiosurgery
n=11 Participants
SRS will be delivered utilizing gamma knife or linear accelerator-based techniques.
Stereotactic Radiosurgery: Maximum Tumor Diameter ≤ 2 cm = 20-24 Gy; Maximum Tumor Diameter 2.1-3.0 cm = 18 Gy; Maximum Tumor Diameter 3.1-5.0 cm = 15 Gy
Surgical Resection: Enrolled patients will receive GK-SRS to all metastases followed by surgical resection of resectable metastases within one to10 days following GK-SRS.
Magnetic Resonance Imaging: Following surgical resection, the patient will enter a standard pattern of surveillance (brain MRI every three months for two years).
|
|---|---|
|
The Number of Subjects With Leptomeningeal Carcinomatosis Using Preoperative SRS.
|
1 Participants
|
SECONDARY outcome
Timeframe: Two yearsRadiation necrosis will be determined by radiographic appearance on posttreatment MRI. The number of patients with radiation necrosis will be documented.
Outcome measures
| Measure |
Stereotactic Radiosurgery
n=11 Participants
SRS will be delivered utilizing gamma knife or linear accelerator-based techniques.
Stereotactic Radiosurgery: Maximum Tumor Diameter ≤ 2 cm = 20-24 Gy; Maximum Tumor Diameter 2.1-3.0 cm = 18 Gy; Maximum Tumor Diameter 3.1-5.0 cm = 15 Gy
Surgical Resection: Enrolled patients will receive GK-SRS to all metastases followed by surgical resection of resectable metastases within one to10 days following GK-SRS.
Magnetic Resonance Imaging: Following surgical resection, the patient will enter a standard pattern of surveillance (brain MRI every three months for two years).
|
|---|---|
|
The Number of Subjects With Radiation Necrosis.
|
0 Participants
|
SECONDARY outcome
Timeframe: Every 3 months until two years; 3, 6, 9, 12, 15, and 18 months reportedQuality 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 quality-of-life assessment. A High Quality of Life was defined a priori as an EQ-5D-5L visual analog scale (VAS) score ≥80, reflecting a high level of self-reported overall health status. This threshold was selected to represent preserved or favorable quality of life and to allow for consistent longitudinal reporting across study time points.
Outcome measures
| Measure |
Stereotactic Radiosurgery
n=11 Participants
SRS will be delivered utilizing gamma knife or linear accelerator-based techniques.
Stereotactic Radiosurgery: Maximum Tumor Diameter ≤ 2 cm = 20-24 Gy; Maximum Tumor Diameter 2.1-3.0 cm = 18 Gy; Maximum Tumor Diameter 3.1-5.0 cm = 15 Gy
Surgical Resection: Enrolled patients will receive GK-SRS to all metastases followed by surgical resection of resectable metastases within one to10 days following GK-SRS.
Magnetic Resonance Imaging: Following surgical resection, the patient will enter a standard pattern of surveillance (brain MRI every three months for two years).
|
|---|---|
|
The Number of Subjects Reporting a High Quality of Life.
3 months
|
3 Participants
|
|
The Number of Subjects Reporting a High Quality of Life.
6 months
|
3 Participants
|
|
The Number of Subjects Reporting a High Quality of Life.
9 months
|
4 Participants
|
|
The Number of Subjects Reporting a High Quality of Life.
12 months
|
3 Participants
|
|
The Number of Subjects Reporting a High Quality of Life.
15 months
|
3 Participants
|
|
The Number of Subjects Reporting a High Quality of Life.
18 months
|
2 Participants
|
Adverse Events
Stereotactic Radiosurgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Surgical Resection
Serious events: 0 serious events
Other events: 1 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stereotactic Radiosurgery
n=11 participants at risk
SRS will be delivered utilizing gamma knife or linear accelerator-based techniques.
Stereotactic Radiosurgery: Maximum Tumor Diameter ≤ 2 cm = 20-24 Gy; Maximum Tumor Diameter 2.1-3.0 cm = 18 Gy; Maximum Tumor Diameter 3.1-5.0 cm = 15 Gy
|
Surgical Resection
n=11 participants at risk
One to 10 days after radiosurgery, the dominant lesion(s) will be maximally resected.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • 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
|
9.1%
1/11 • Number of events 1 • 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
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • 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
|
9.1%
1/11 • Number of events 1 • 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
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/11 • 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
|
9.1%
1/11 • Number of events 1 • 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
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/11 • 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
|
9.1%
1/11 • Number of events 1 • 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
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/11 • 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
|
9.1%
1/11 • Number of events 1 • 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
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/11 • 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
|
9.1%
1/11 • Number of events 1 • 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
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/11 • 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
|
9.1%
1/11 • Number of events 1 • 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
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • 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
|
9.1%
1/11 • Number of events 1 • 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
|
|
General disorders
Fatigue
|
0.00%
0/11 • 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
|
9.1%
1/11 • Number of events 1 • 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
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • 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
|
9.1%
1/11 • Number of events 1 • 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
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/11 • 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
|
9.1%
1/11 • Number of events 1 • 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
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/11 • 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
|
9.1%
1/11 • Number of events 1 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place