Stereotactic Body Radiotherapy for Spine Tumors

Study Overview
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Brief Summary
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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
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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

Official Title
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Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Spine Metastases and Primary Spine Tumors

Conditions
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Spinal Metastases, Vertebral Metastases, Benign Spinal Tumors, Chordoma, Meningioma, Schwannoma, Neurofibroma, Paragangliomas, Arteriovenous Malformations

Intervention / Treatment
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* Radiation: SBRT for Benign Extradural Spine Tumors
* Radiation: SBRT for Vertebral/Paraspinal Metastases


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SBRT for Benign Extradural Spine Tumors<br>Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs). | Radiation: SBRT for Benign Extradural Spine Tumors<br>* 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)<br>* Other names: Stereotactic Body Radiotherapy (SBRT);|
| Other: SBRT for Vertebral/Paraspinal Metastases<br>Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy | Radiation: SBRT for Vertebral/Paraspinal Metastases<br>* 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)<br>* Other names: Stereotactic Body Radiotherapy (SBRT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stereotactic radiotherapy, vertebral metastases, benign spinal tumors, spinal metastases