Trial Outcomes & Findings for Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s) (NCT NCT02225223)
NCT ID: NCT02225223
Last Updated: 2021-08-11
Results Overview
The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Primary outcome is measuring the mean change from baseline in BPI worst pain score at 6 weeks.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Mean change from baseline to 6 weeks
Results posted on
2021-08-11
Participant Flow
Participant milestones
| Measure |
No Previous Radiation Therapy
Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)
|
Failed/Refuse Further Radiation Therapy
Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
8
|
|
Overall Study
COMPLETED
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
19
|
5
|
Reasons for withdrawal
| Measure |
No Previous Radiation Therapy
Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)
|
Failed/Refuse Further Radiation Therapy
Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)
|
|---|---|---|
|
Overall Study
Death
|
10
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
|
Overall Study
Other
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)
Baseline characteristics by cohort
| Measure |
No Previous Radiation Therapy
n=27 Participants
Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)
|
Failed/Refuse Further Radiation Therapy
n=8 Participants
Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 15.3 • n=93 Participants
|
53.4 years
STANDARD_DEVIATION 15.23 • n=4 Participants
|
60.2 years
STANDARD_DEVIATION 15.52 • n=27 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Primary Cancer
Breast Cancer
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Primary Cancer
Prostate Cancer
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Primary Cancer
Prostate Cancer and Other
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Primary Cancer
Small Cell Lung Cancer
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Primary Cancer
Non-Small Cell Lung Cancer
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Primary Cancer
Thyroid Cancer
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Primary Cancer
Other
|
13 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Brief Pain Inventory (BPI -Short Form) - 24 hour worst pain
|
7.9 units on a scale
STANDARD_DEVIATION 1.93 • n=93 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 1.46 • n=4 Participants
|
7.7 units on a scale
STANDARD_DEVIATION 1.84 • n=27 Participants
|
PRIMARY outcome
Timeframe: Mean change from baseline to 6 weeksThe Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Primary outcome is measuring the mean change from baseline in BPI worst pain score at 6 weeks.
Outcome measures
| Measure |
No Previous Radiation Therapy
n=27 Participants
Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)
|
Failed/Refuse Further Radiation Therapy
n=8 Participants
Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)
|
|---|---|---|
|
Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks
|
2.3 score on a scale
Standard Deviation 1.48
|
1.8 score on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Mean Change from Baseline prior to 6 weeksMeasured by Brief Pain Inventory (BPI) Pain Q3, The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is measuring the mean change from baseline in BPI worst pain score prior to 6 weeks.
Outcome measures
| Measure |
No Previous Radiation Therapy
n=27 Participants
Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)
|
Failed/Refuse Further Radiation Therapy
n=8 Participants
Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)
|
|---|---|---|
|
Mean Change From Baseline in Brief Pain Inventory Worst Pain Score at Visits Prior to 6 Weeks
|
2.1 score on a scale
Standard Deviation 1.75
|
1.5 score on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 6The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is the response to Q3 at Weeks 1, 2 and 6.
Outcome measures
| Measure |
No Previous Radiation Therapy
n=27 Participants
Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)
|
Failed/Refuse Further Radiation Therapy
n=8 Participants
Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)
|
|---|---|---|
|
Brief Pain Inventory Q3 Worst Pain Score by Visit
Week 1
|
4.5 score on a scale
Standard Deviation 3.00
|
4.9 score on a scale
Standard Deviation 2.67
|
|
Brief Pain Inventory Q3 Worst Pain Score by Visit
Week 2
|
3.9 score on a scale
Standard Deviation 3.05
|
5.3 score on a scale
Standard Deviation 2.12
|
|
Brief Pain Inventory Q3 Worst Pain Score by Visit
Week 6
|
3.6 score on a scale
Standard Deviation 2.87
|
3.8 score on a scale
Standard Deviation 1.91
|
Adverse Events
No Previous Radiation Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 10 deaths
Failed/Refuse Further Radiation Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place