Clinical trial · Interventional
Stereotactic Body Radiotherapy for Spine Tumors
Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Spine Metastases and Primary Spine Tumors
NCT01347307CI-TRIAL-00045599completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arteriovenous Malformations | — | UNRESOLVED | — |
| Benign Spinal Tumors | — | UNRESOLVED | — |
| Chordoma | Chordoma | ONTOLOGY_EXACT | 0.98 |
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
| Neurofibroma | Neurofibroma | ONTOLOGY_EXACT | 0.98 |
| Paragangliomas | Paraganglioma | ALIAS | 0.90 |
| Schwannoma | Schwannoma | ONTOLOGY_EXACT | 0.98 |
| Spinal Metastases | — | UNRESOLVED | — |
| Vertebral Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT for Benign Extradural Spine Tumors | Radiation | — | UNRESOLVED |
| SBRT for Vertebral/Paraspinal Metastases | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- SBRT for Benign Extradural Spine Tumors
- description
- Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
- interventionNames
- Radiation: SBRT for Benign Extradural Spine Tumors
- type
- OTHER
- label
- SBRT for Vertebral/Paraspinal Metastases
- description
- Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
- interventionNames
- Radiation: SBRT for Vertebral/Paraspinal Metastases
Primary outcomes (2)
- measure
- Initial Symptom Control
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.