Trial Outcomes & Findings for Randomized Study of Stereotactic Body Radiotherapy vs. Conventional Radiation for Spine Metastasis (NCT NCT01525745)
NCT ID: NCT01525745
Last Updated: 2017-03-06
Results Overview
Determine if image-guided radiosurgery/SBRT improves pain control as measured by NPRS as compared to conventional external beam radiotherapy
TERMINATED
PHASE2
6 participants
2 years
2017-03-06
Participant Flow
all participants were enrolled in the RadOnc clinic at BIDMC
Participant milestones
| Measure |
Radiosurgery/SBRT
Radiosurgery/SBRT
Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
|
External Beam Radiation Therapy
External Beam Radiation Therapy
External Beam Radiation Therapy: 10 consecutive days of standard radiation
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Study of Stereotactic Body Radiotherapy vs. Conventional Radiation for Spine Metastasis
Baseline characteristics by cohort
| Measure |
A/Radiosurgery-SBRT
n=4 Participants
Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
|
B/External Beam Radiation Therapy
n=2 Participants
External Beam Radiation Therapy: 10 consecutive days of standard radiation
|
Total
n=6 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: study was terminated by the local IRB due to slow accrual. 1 participant withdrew consent and 1 participant did not complete the assigned arm treatment per protocol and then removed from study. left with 4 participants and data were not collected for any participants therefore no analysis has been done.
Determine if image-guided radiosurgery/SBRT improves pain control as measured by NPRS as compared to conventional external beam radiotherapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: data not collected, therefore no analysis done
Determine if image-guided radiosurgery/SBRT improves duration of pain as compared to conventional external beam radiotherapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: data not collected, therefore no analysis done
Evaluate potential benefit of image-guided radiosurgery/SBRT on change in and overall quality of life as measured by FACT-G, BPI and EQ-5D
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: data not collected, therefore no analysis done
Long term effects of image-guided radiosurgery/SBRT on the vertevral bone and spinal cord
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: data not collected, therefore no analysis done
Progrsesion Free and Overall Survival
Outcome measures
Outcome data not reported
Adverse Events
A/Radiosurgery-SBRT
B/External Beam Radiation Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anand Mahadevan, MD
Beth Israel Deaconess Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place