Arteriovenous Malformations, Benign Spinal Tumors, Chordoma, Meningioma, Neurofibroma, Paragangliomas, Schwannoma, Spinal Metastases, Vertebral Metastases
Conditions
Keywords
stereotactic radiotherapy, spinal metastases, vertebral metastases, benign spinal tumors
Brief summary
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine tumors.
Detailed description
This study is a single site, non-randomized, prospective, phase IV trial. Patients are composed of 2 groups:Spine Metastases OR Benign Spine Tumors. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years
Interventions
RADIATIONSBRT 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)
RADIATIONSBRT 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)
Sponsors
Mercy Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria: * Patient age \>= 18 years * performance status of 0-3 * Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy * Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs). * Established histologic diagnosis of a benign or malignant tumor of the spine. * Arteriovenous malformation of the spine identified radiographically (no biopsy) * Well-defined lesion involving no more than 2 adjacent vertebral levels or spinal segment * Minimal spinal canal compromise that is not rapidly progressive. Ideally, the tumor should not be within 5 mm of the spinal cord. * If chemotherapy is planned, ideally it should not have been given within 30 days of starting radiation and should not resume until at least 2 weeks after completing radiation. In addition, it is not recommended to perform SBRT when targeted anti-angiogenesis therapy is planned within 2 months of the procedure. * Signed study-specific consent form
Exclusion criteria
* Lesion involving \> 3 adjacent vertebral levels * Overt spinal instability * Neurologic deficit due to bony fragments/bony compression of neural structures * Prior radiotherapy at the involved level(s) within 3 months of radiosurgery, more than one prior course of radiotherapy at the involved level(s), or more than 45 Gy previous radiation exposure at the involved level(s) * Rapidly progressive spinal cord compromise or neurological deficit * Paralysis, or otherwise compromised motor function due to radiographically confirmed cord compression * Patient unable to undergo an MRI * Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females * Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial Symptom Control | 6 weeks post-SBRT (or at first post-treatment follow-up) | Evaluation of pain relief per patient report |
| Local Tumor Recurrence Rate | (1) At 1 year post-SBRT, (2) At patient's last follow-up or time of death | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Toxicity Rate | at patient's last follow-up (at least 3 months from treatment) or time of death | Toxicity will be assessed using CTCAE grading criteria at specified timepoints. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SBRT for Benign Extradural Spine Tumors 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) | 3 |
| 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) | 35 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 4 |
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | SBRT for Vertebral/Paraspinal Metastases | Total | SBRT for Benign Extradural Spine Tumors |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 16 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 22 Participants | 2 Participants |
| Age, Continuous Age Range | 62 years | 62 years | 64 years |
| Race/Ethnicity, Customized Race African American | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Caucasion | 32 Participants | 35 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 35 Participants | 38 Participants | 3 Participants |
| Sex: Female, Male Female | 20 Participants | 22 Participants | 2 Participants |
| Sex: Female, Male Male | 15 Participants | 16 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 27 / 28 |
| other Total, other adverse events | 1 / 3 | 7 / 28 |
| serious Total, serious adverse events | 0 / 3 | 1 / 28 |
Outcome results
Primary
Initial Symptom Control
Evaluation of pain relief per patient report
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SBRT for Benign Extradural Spine Tumors | Initial Symptom Control | Number with Follow-up Data | 3 Participants |
| SBRT for Benign Extradural Spine Tumors | Initial Symptom Control | Number with Initial Symptom Control | 3 Participants |
| SBRT for Benign Extradural Spine Tumors | Initial Symptom Control | Number without Symptom Control | 0 Participants |
| SBRT for Vertebral/Paraspinal Metastases | Initial Symptom Control | Number with Follow-up Data | 28 Participants |
| SBRT for Vertebral/Paraspinal Metastases | Initial Symptom Control | Number with Initial Symptom Control | 27 Participants |
| SBRT for Vertebral/Paraspinal Metastases | Initial Symptom Control | Number without Symptom Control | 1 Participants |
Primary
Local Tumor Recurrence Rate
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.
Time frame: (1) At 1 year post-SBRT, (2) At patient's last follow-up or time of death
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SBRT for Benign Extradural Spine Tumors | Local Tumor Recurrence Rate | Number with at least 1 year Follow-up | 3 Participants |
| SBRT for Benign Extradural Spine Tumors | Local Tumor Recurrence Rate | Local Control at last Follow-up | 3 Participants |
| SBRT for Benign Extradural Spine Tumors | Local Tumor Recurrence Rate | Local Control at 1 year Follow-up | 3 Participants |
| SBRT for Benign Extradural Spine Tumors | Local Tumor Recurrence Rate | Local Recurrence after Initial Response | 0 Participants |
| SBRT for Benign Extradural Spine Tumors | Local Tumor Recurrence Rate | Local Recurrence within 1st year of Follow-up | 0 Participants |
| SBRT for Benign Extradural Spine Tumors | Local Tumor Recurrence Rate | No Response to Treatment | 0 Participants |
| SBRT for Vertebral/Paraspinal Metastases | Local Tumor Recurrence Rate | Local Recurrence within 1st year of Follow-up | 1 Participants |
| SBRT for Vertebral/Paraspinal Metastases | Local Tumor Recurrence Rate | No Response to Treatment | 1 Participants |
| SBRT for Vertebral/Paraspinal Metastases | Local Tumor Recurrence Rate | Local Recurrence after Initial Response | 2 Participants |
| SBRT for Vertebral/Paraspinal Metastases | Local Tumor Recurrence Rate | Number with at least 1 year Follow-up | 18 Participants |
| SBRT for Vertebral/Paraspinal Metastases | Local Tumor Recurrence Rate | Local Control at 1 year Follow-up | 17 Participants |
| SBRT for Vertebral/Paraspinal Metastases | Local Tumor Recurrence Rate | Local Control at last Follow-up | 25 Participants |
Secondary
Late Toxicity Rate
Toxicity will be assessed using CTCAE grading criteria at specified timepoints.
Time frame: at patient's last follow-up (at least 3 months from treatment) or time of death
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SBRT for Benign Extradural Spine Tumors | Late Toxicity Rate | 0 participants |
| SBRT for Vertebral/Paraspinal Metastases | Late Toxicity Rate | 0 participants |