Trial Outcomes & Findings for Stereotactic Body Radiotherapy for Spine Tumors (NCT NCT01347307)
NCT ID: NCT01347307
Last Updated: 2020-06-18
Results Overview
Evaluation of pain relief per patient report
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
6 weeks post-SBRT (or at first post-treatment follow-up)
Results posted on
2020-06-18
Participant Flow
Participant milestones
| Measure |
SBRT for Benign Extradural Spine Tumors
Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
Stereotactic Body Radiation Therapy (SBRT) for Benign Extradural Spine Tumors: 14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
SBRT for Vertebral/Paraspinal Metastases
Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
SBRT for Vertebral/Paraspinal Metastases: 12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
33
|
|
Overall Study
COMPLETED
|
3
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
SBRT for Benign Extradural Spine Tumors
Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
Stereotactic Body Radiation Therapy (SBRT) for Benign Extradural Spine Tumors: 14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
SBRT for Vertebral/Paraspinal Metastases
Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
SBRT for Vertebral/Paraspinal Metastases: 12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
|---|---|---|
|
Overall Study
Death
|
0
|
4
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Stereotactic Body Radiotherapy for Spine Tumors
Baseline characteristics by cohort
| Measure |
SBRT for Benign Extradural Spine Tumors
n=3 Participants
Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
SBRT for Benign Extradural Spine Tumors: 14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
SBRT for Vertebral/Paraspinal Metastases
n=35 Participants
Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
SBRT for Vertebral/Paraspinal Metastases: 12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Continuous
Age Range
|
64 years
n=99 Participants
|
62 years
n=107 Participants
|
62 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasion
|
3 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post-SBRT (or at first post-treatment follow-up)Population: 2 enrolled pts were not treated. 35 pts completed 36 SBRT courses. 5 pts either died prior to any follow-up appointment or imaging (4 pts) or did not follow-up due to loss of insurance (1 pt). 3 pts with benign spine tumors and 28 pts with vertebral metastases who underwent a total of 32 courses of SBRT had follow-up data available for analysis.
Evaluation of pain relief per patient report
Outcome measures
| Measure |
SBRT for Benign Extradural Spine Tumors
n=3 Participants
Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
SBRT for Benign Extradural Spine Tumors: 14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
SBRT for Vertebral/Paraspinal Metastases
n=28 Participants
Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
SBRT for Vertebral/Paraspinal Metastases: 12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
|---|---|---|
|
Initial Symptom Control
Number with Follow-up Data
|
3 Participants
|
28 Participants
|
|
Initial Symptom Control
Number with Initial Symptom Control
|
3 Participants
|
27 Participants
|
|
Initial Symptom Control
Number without Symptom Control
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: (1) At 1 year post-SBRT, (2) At patient's last follow-up or time of deathPopulation: 35 pts completed 36 SBRT courses. All 3 benign tumor pts are still alive. 15 pts with metastatic disease died prior to first post-SBRT follow-up appointment or imaging (4 pts), did not follow-up due to loss of insurance (1 pt), or had initial follow-up but then died prior to 1 year from treatment completion (10 pts).
Local recurrence is defined as tumor recurrence or progression within the planning target volume. Local control rate will be evaluated by imaging techniques and/or clinical symptoms (worsening or no improvement in pain or neurologic compromise). If follow-up imaging is available, a local recurrence will be defined as an increase of \> 20% in tumor size.
Outcome measures
| Measure |
SBRT for Benign Extradural Spine Tumors
n=3 Participants
Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
SBRT for Benign Extradural Spine Tumors: 14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
SBRT for Vertebral/Paraspinal Metastases
n=28 Participants
Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
SBRT for Vertebral/Paraspinal Metastases: 12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
|---|---|---|
|
Local Tumor Recurrence Rate
Local Control at last Follow-up
|
3 Participants
|
25 Participants
|
|
Local Tumor Recurrence Rate
No Response to Treatment
|
0 Participants
|
1 Participants
|
|
Local Tumor Recurrence Rate
Local Recurrence after Initial Response
|
0 Participants
|
2 Participants
|
|
Local Tumor Recurrence Rate
Number with at least 1 year Follow-up
|
3 Participants
|
18 Participants
|
|
Local Tumor Recurrence Rate
Local Control at 1 year Follow-up
|
3 Participants
|
17 Participants
|
|
Local Tumor Recurrence Rate
Local Recurrence within 1st year of Follow-up
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: at patient's last follow-up (at least 3 months from treatment) or time of deathPopulation: 2 enrolled pts were not treated. 35 pts completed 36 SBRT courses. 5 pts either died prior to any follow-up appointment or imaging (4 pts) or did not follow-up due to loss of insurance (1 pt). 3 pts with benign spine tumors and 28 pts with vertebral metastases who underwent a total of 32 courses of SBRT had follow-up data available for analysis.
Toxicity will be assessed using CTCAE grading criteria at specified timepoints.
Outcome measures
| Measure |
SBRT for Benign Extradural Spine Tumors
n=3 Participants
Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
SBRT for Benign Extradural Spine Tumors: 14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
SBRT for Vertebral/Paraspinal Metastases
n=28 Participants
Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
SBRT for Vertebral/Paraspinal Metastases: 12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
|---|---|---|
|
Late Toxicity Rate
|
0 participants
|
0 participants
|
Adverse Events
SBRT for Benign Extradural Spine Tumors
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SBRT for Vertebral/Paraspinal Metastases
Serious events: 1 serious events
Other events: 7 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
SBRT for Benign Extradural Spine Tumors
n=3 participants at risk
Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
SBRT for Benign Extradural Spine Tumors: 14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
SBRT for Vertebral/Paraspinal Metastases
n=28 participants at risk
Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
SBRT for Vertebral/Paraspinal Metastases: 12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
|---|---|---|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/3 • Patients were followed until time of death or until lost to follow-up.
Serious adverse events are defined as events that result in either death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Events not meeting this definition are listed under Other Adverse Events (not serious). Only 28 of the patients within the metastases arm had follow-up data collected.
|
3.6%
1/28 • Number of events 1 • Patients were followed until time of death or until lost to follow-up.
Serious adverse events are defined as events that result in either death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Events not meeting this definition are listed under Other Adverse Events (not serious). Only 28 of the patients within the metastases arm had follow-up data collected.
|
Other adverse events
| Measure |
SBRT for Benign Extradural Spine Tumors
n=3 participants at risk
Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
SBRT for Benign Extradural Spine Tumors: 14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
SBRT for Vertebral/Paraspinal Metastases
n=28 participants at risk
Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
SBRT for Vertebral/Paraspinal Metastases: 12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
|
|---|---|---|
|
Gastrointestinal disorders
Self limiting nausea
|
33.3%
1/3 • Number of events 1 • Patients were followed until time of death or until lost to follow-up.
Serious adverse events are defined as events that result in either death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Events not meeting this definition are listed under Other Adverse Events (not serious). Only 28 of the patients within the metastases arm had follow-up data collected.
|
10.7%
3/28 • Number of events 3 • Patients were followed until time of death or until lost to follow-up.
Serious adverse events are defined as events that result in either death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Events not meeting this definition are listed under Other Adverse Events (not serious). Only 28 of the patients within the metastases arm had follow-up data collected.
|
|
Skin and subcutaneous tissue disorders
desquamation
|
0.00%
0/3 • Patients were followed until time of death or until lost to follow-up.
Serious adverse events are defined as events that result in either death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Events not meeting this definition are listed under Other Adverse Events (not serious). Only 28 of the patients within the metastases arm had follow-up data collected.
|
3.6%
1/28 • Number of events 1 • Patients were followed until time of death or until lost to follow-up.
Serious adverse events are defined as events that result in either death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Events not meeting this definition are listed under Other Adverse Events (not serious). Only 28 of the patients within the metastases arm had follow-up data collected.
|
|
Gastrointestinal disorders
mild esophagitis
|
0.00%
0/3 • Patients were followed until time of death or until lost to follow-up.
Serious adverse events are defined as events that result in either death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Events not meeting this definition are listed under Other Adverse Events (not serious). Only 28 of the patients within the metastases arm had follow-up data collected.
|
7.1%
2/28 • Number of events 2 • Patients were followed until time of death or until lost to follow-up.
Serious adverse events are defined as events that result in either death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Events not meeting this definition are listed under Other Adverse Events (not serious). Only 28 of the patients within the metastases arm had follow-up data collected.
|
|
Musculoskeletal and connective tissue disorders
muscle pain
|
0.00%
0/3 • Patients were followed until time of death or until lost to follow-up.
Serious adverse events are defined as events that result in either death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Events not meeting this definition are listed under Other Adverse Events (not serious). Only 28 of the patients within the metastases arm had follow-up data collected.
|
3.6%
1/28 • Number of events 1 • Patients were followed until time of death or until lost to follow-up.
Serious adverse events are defined as events that result in either death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Events not meeting this definition are listed under Other Adverse Events (not serious). Only 28 of the patients within the metastases arm had follow-up data collected.
|
Additional Information
Lead Regulatory Coordinator - Investigator Initiated Trials
Mercy Research
Phone: 314-251-8827
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place