Trial Outcomes & Findings for Palliative Lattice Stereotactic Body Radiotherapy (SBRT) (NCT NCT04133415)
NCT ID: NCT04133415
Last Updated: 2021-11-22
Results Overview
-Measured by CTCAE version 5.0
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Through 90 days following completion of radiotherapy (estimated to be 90 days and 2 weeks)
Results posted on
2021-11-22
Participant Flow
Participant milestones
| Measure |
Lattice Stereotactic Body Radiation Therapy
-Lattice SBRT prescribed to a dose of 20 Gy in 5 fractions with a simultaneous integrated boosts of 66.7 Gy in 5 fractions
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Palliative Lattice Stereotactic Body Radiotherapy (SBRT)
Baseline characteristics by cohort
| Measure |
Lattice Stereotactic Body Radiation Therapy
n=20 Participants
-Lattice SBRT prescribed to a dose of 20 Gy in 5 fractions with a simultaneous integrated boosts of 66.7 Gy in 5 fractions
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 90 days following completion of radiotherapy (estimated to be 90 days and 2 weeks)-Measured by CTCAE version 5.0
Outcome measures
| Measure |
Lattice Stereotactic Body Radiation Therapy
n=20 Participants
-Lattice SBRT prescribed to a dose of 20 Gy in 5 fractions with a simultaneous integrated boosts of 66.7 Gy in 5 fractions
|
|---|---|
|
Percentage of Patients With Treatment-related, Non-hematologic, Grade 3 or Higher Adverse Events
|
1 Participants
|
Adverse Events
Lattice Stereotactic Body Radiation Therapy
Serious events: 1 serious events
Other events: 20 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Lattice Stereotactic Body Radiation Therapy
n=20 participants at risk
-Lattice SBRT prescribed to a dose of 20 Gy in 5 fractions with a simultaneous integrated boosts of 66.7 Gy in 5 fractions
|
|---|---|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
Other adverse events
| Measure |
Lattice Stereotactic Body Radiation Therapy
n=20 participants at risk
-Lattice SBRT prescribed to a dose of 20 Gy in 5 fractions with a simultaneous integrated boosts of 66.7 Gy in 5 fractions
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Cardiac disorders
Atrial flutter
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
4/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
4/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Infections and infestations
COVID-19
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Investigations
Weight loss
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Gastrointestinal disorders
Anorexia
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Gastrointestinal disorders
Dehydration
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Nervous system disorders
Encephalopathy
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Nervous system disorders
Memory impairment
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Renal and urinary disorders
Bladder spasm
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Renal and urinary disorders
Hematuria
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dypsnea
|
15.0%
3/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
2/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
|
Vascular disorders
Thromboembolic event
|
5.0%
1/20 • Adverse events were collected from start of treatment through 90 days following completion of treatment.
|
Additional Information
Matthew Spraker, M.D., Ph.D.
Washington University School of Medicine
Phone: 314-362-8567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place