Trial Outcomes & Findings for A Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain Metastases (NCT NCT03412812)
NCT ID: NCT03412812
Last Updated: 2025-11-04
Results Overview
To determine the maximum tolerated dose of five fraction stereotactic radiotherapy for patients with either tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
1-2 years
Results posted on
2025-11-04
Participant Flow
Participant milestones
| Measure |
2.1-4.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery.
|
4.1-6.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery.
|
|---|---|---|
|
Level 1
STARTED
|
12
|
1
|
|
Level 1
COMPLETED
|
9
|
0
|
|
Level 1
NOT COMPLETED
|
3
|
1
|
|
Level 2
STARTED
|
0
|
0
|
|
Level 2
COMPLETED
|
0
|
0
|
|
Level 2
NOT COMPLETED
|
0
|
0
|
|
Level 3
STARTED
|
0
|
0
|
|
Level 3
COMPLETED
|
0
|
0
|
|
Level 3
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
2.1-4.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery.
|
4.1-6.0 cm diameter
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery.
|
|---|---|---|
|
Level 1
Death
|
3
|
0
|
|
Level 1
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain Metastases
Baseline characteristics by cohort
| Measure |
2.1-4.0 cm diameter
n=12 Participants
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery.
|
4.1-6.0 cm diameter
n=1 Participants
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
9 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
4 Participants
n=100 Participants
|
|
Age, Continuous
|
65 years
n=15 Participants
|
65 years
n=161 Participants
|
65 years
n=100 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
8 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
5 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
3 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
9 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
10 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=15 Participants
|
1 participants
n=161 Participants
|
13 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 1-2 yearsTo determine the maximum tolerated dose of five fraction stereotactic radiotherapy for patients with either tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter
Outcome measures
| Measure |
Dose Escalated 5 Fraction Stereotactic Radiosurgery - 2.1-4.0 cm
n=12 Participants
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Tumors must fall into one of two categories: 2.1-4.0cm diameter. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery.
Dose Escalated Five Fraction Stereotactic Radiosurgery: As focal radiation techniques are utilized more frequently in the treatment of brain metastases, there is increasing need to accurately define the appropriate patient and tumor characteristics for focal therapy. Unfortunately, not all patients are good candidates for single fraction stereotactic radiosurgery (SRS) since large tumors and those in unfavorable locations have been associated with unacceptable rates of treatment-related toxicity. Five fraction stereotactic radiation has proven to be a more effective treatment for these patients that aren't good candidates.
|
Dose Escalated 5 Fraction Stereotactic Radiosurgery - 4.1-6.0 cm
n=1 Participants
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Tumors must fall into one of two categories: 4.1-6.0cm diameter. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery.
Dose Escalated Five Fraction Stereotactic Radiosurgery: As focal radiation techniques are utilized more frequently in the treatment of brain metastases, there is increasing need to accurately define the appropriate patient and tumor characteristics for focal therapy. Unfortunately, not all patients are good candidates for single fraction stereotactic radiosurgery (SRS) since large tumors and those in unfavorable locations have been associated with unacceptable rates of treatment-related toxicity. Five fraction stereotactic radiation has proven to be a more effective treatment for these patients that aren't good candidates.
|
|---|---|---|
|
Maximum Tolerated Dose of Five Fraction Stereotactic Radiotherapy
|
35 Gy
|
30 Gy
|
SECONDARY outcome
Timeframe: 1-2 yearsTo assess the acute toxicity of five fraction stereotactic radiotherapy for tumors 2-6 cm in diameter using the RAD 1705 Adverse Events Assessment. This assessment was created within our department and will be used specifically for this study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1-2 yearsTo assess the late toxicity of five fraction stereotactic radiotherapy for tumors 2-6 cm in diameter using the RAD 1705 Adverse Events Assessment. This assessment was created within our department and will be used specifically for this study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1-2 yearsTo determine the rate of local tumor control with five fraction stereotactic radiotherapy for tumors 2-6 cm in diameter using the RAD 1705 Adverse Events Assessment. This assessment was created within our department and will be used specifically for this study.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-2 yearsTo assess the feasibility of capturing patient reported outcomes with the Functional Assessment of Cancer Therapy-Brain Questionnaire (FACT-Br) electronically in the Radiation Oncology clinic
Outcome measures
Outcome data not reported
Adverse Events
2.1-4.0 cm diameter
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
4.1-6.0 cm diameter
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2.1-4.0 cm diameter
n=12 participants at risk
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery.
|
4.1-6.0 cm diameter
n=1 participants at risk
Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
|
Renal and urinary disorders
Urinary Tract Infection
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
|
General disorders
Cognitive Disability
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
|
Surgical and medical procedures
Radiation Necrosis
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
|
General disorders
Stroke
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
|
Infections and infestations
Sepsis
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Dysarthria
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Seizure
|
0.00%
0/12 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place