Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT for Benign Extradural Spine Tumors | Other | Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs). |
|
| SBRT for Vertebral/Paraspinal Metastases | Other | Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT for Benign Extradural Spine Tumors | Radiation | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Initial Symptom Control | Evaluation of pain relief per patient report | 6 weeks post-SBRT (or at first post-treatment follow-up) |
| 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. | (1) At 1 year post-SBRT, (2) At patient's last follow-up or time of death |
| Measure | Description | Time Frame |
|---|---|---|
| Late Toxicity Rate | Toxicity will be assessed using CTCAE grading criteria at specified timepoints. | at patient's last follow-up (at least 3 months from treatment) or time of death |
Not provided
Eligibility Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bethany Sleckman, MD | Mercy Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Medical Center, St. Louis | St Louis | Missouri | 63141 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 enrolled patients were not treated. 35 patients completed 36 Stereotactic Body Radiotherapy courses for a total of 38 patients included at baseline.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Initial Symptom Control | Evaluation of pain relief per patient report | 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. | Posted | Count of Participants | Participants | 6 weeks post-SBRT (or at first post-treatment follow-up) |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophagitis | Gastrointestinal disorders | Non-systematic Assessment | Esophagitis requiring management with triple mix (Benadryl/Maalox/Lidocaine), oral steroids, Vicodin, and a soft diet, and resulted in < 10 pound weight loss. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Self limiting nausea | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lead Regulatory Coordinator - Investigator Initiated Trials | Mercy Research | 314-251-8827 | michelle.mcfarland@mercy.net |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2013 | Jun 12, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002817 | Chordoma |
| D008579 | Meningioma |
| D009442 | Neurilemmoma |
| D009455 | Neurofibroma |
| D010235 | Paraganglioma |
| D001165 | Arteriovenous Malformations |
| ID | Term |
|---|---|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| SBRT for Vertebral/Paraspinal Metastases | Radiation | 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) |
|
|
| BG001 |
| 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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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) |
|
|
| 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. | 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). | Posted | Count of Participants | Participants | (1) At 1 year post-SBRT, (2) At patient's last follow-up or time of death |
|
|
|
| Secondary | Late Toxicity Rate | Toxicity will be assessed using CTCAE grading criteria at specified timepoints. | 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. | Posted | Number | participants | at patient's last follow-up (at least 3 months from treatment) or time of death |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | 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) | 27 | 28 | 1 | 28 | 7 | 28 |
|
| desquamation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | skin redness and peeling |
|
| mild esophagitis | Gastrointestinal disorders | Non-systematic Assessment | esophagitis lasting less than 7 days, not interfering with eating, no or minimal intervention required |
|
| muscle pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | temporary increased pain at treated site |
|
Not provided
Not provided
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009463 | Neuroma |
| D018317 | Nerve Sheath Neoplasms |
| D010524 | Peripheral Nervous System Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| Local Recurrence after Initial Response |
|
| Number with at least 1 year Follow-up |
|
| Local Control at 1 year Follow-up |
|
| Local Recurrence within 1st year of Follow-up |
|