Trial Outcomes & Findings for Preoperative SRS/SRT vs Postoperative SRS/SRT for Brain Metastases (NCT NCT04422639)
NCT ID: NCT04422639
Last Updated: 2023-07-28
Results Overview
A CNS CE will consist of one of the following three events: Local Recurrence (LR) of the treated lesions, symptomatic radiation necrosis (SRN) to the treated lesions, or development of leptomeningeal disease (LMD).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
From date of randomization to the date of a documented LR, SRN, or LMD, whichever comes first, assessed up to 18 months.
Results posted on
2023-07-28
Participant Flow
Participant milestones
| Measure |
Arm I (Pre-operative SRS/SRT)
Patients undergo SRS or SRT within 15 days of randomization followed by surgery within 15 days of radiation completion. Patients may undergo additional SRS or SRT if disease returns after treatment.
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT
|
Arm II (Post-operative SRS/SRT)
Patients undergo surgery within 15 days of randomization followed by standard-of-care SRS or SRT within 30 days of surgery. Patients may undergo additional SRS or SRT if disease returns after treatment.
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Arm I (Pre-operative SRS/SRT)
Patients undergo SRS or SRT within 15 days of randomization followed by surgery within 15 days of radiation completion. Patients may undergo additional SRS or SRT if disease returns after treatment.
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT
|
Arm II (Post-operative SRS/SRT)
Patients undergo surgery within 15 days of randomization followed by standard-of-care SRS or SRT within 30 days of surgery. Patients may undergo additional SRS or SRT if disease returns after treatment.
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
study closed prior to completion of FU visits
|
0
|
2
|
Baseline Characteristics
Preoperative SRS/SRT vs Postoperative SRS/SRT for Brain Metastases
Baseline characteristics by cohort
| Measure |
Arm I (Pre-operative SRS/SRT)
n=1 Participants
Patients undergo SRS or SRT within 15 days of randomization followed by surgery within 15 days of radiation completion. Patients may undergo additional SRS or SRT if disease returns after treatment.
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT
|
Arm II (Post-operative SRS/SRT)
n=2 Participants
Patients undergo surgery within 15 days of randomization followed by standard-of-care SRS or SRT within 30 days of surgery. Patients may undergo additional SRS or SRT if disease returns after treatment.
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to the date of a documented LR, SRN, or LMD, whichever comes first, assessed up to 18 months.Population: No data displayed because Outcome Measure has zero total participants analyzed due to low enrollment and early study termination. Study closed prior to completion of follow-up visits so there is nothing to analyze.
A CNS CE will consist of one of the following three events: Local Recurrence (LR) of the treated lesions, symptomatic radiation necrosis (SRN) to the treated lesions, or development of leptomeningeal disease (LMD).
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Pre-operative SRS/SRT)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Arm II (Post-operative SRS/SRT)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Pre-operative SRS/SRT)
n=1 participants at risk
Patients undergo SRS or SRT within 15 days of randomization followed by surgery within 15 days of radiation completion. Patients may undergo additional SRS or SRT if disease returns after treatment.
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT
|
Arm II (Post-operative SRS/SRT)
n=2 participants at risk
Patients undergo surgery within 15 days of randomization followed by standard-of-care SRS or SRT within 30 days of surgery. Patients may undergo additional SRS or SRT if disease returns after treatment.
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT
|
|---|---|---|
|
General disorders
Left hemiplegia
|
0.00%
0/1 • 1 year
|
50.0%
1/2 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Arm I (Pre-operative SRS/SRT)
n=1 participants at risk
Patients undergo SRS or SRT within 15 days of randomization followed by surgery within 15 days of radiation completion. Patients may undergo additional SRS or SRT if disease returns after treatment.
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT
|
Arm II (Post-operative SRS/SRT)
n=2 participants at risk
Patients undergo surgery within 15 days of randomization followed by standard-of-care SRS or SRT within 30 days of surgery. Patients may undergo additional SRS or SRT if disease returns after treatment.
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/2 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/2 • 1 year
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/1 • 1 year
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Eye disorders
Vision decrease
|
0.00%
0/1 • 1 year
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • 1 year
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/1 • 1 year
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/1 • 1 year
|
50.0%
1/2 • Number of events 1 • 1 year
|
Additional Information
Assistant Director of Cancer Clinical Trials
University of Arkansas for Medical Sciences
Phone: 501-686-8274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place