Stereotactic Body Radiotherapy for Spine Tumors
- Conditions
- Spinal MetastasesVertebral MetastasesMeningiomaSchwannomaNeurofibromaParagangliomasArteriovenous MalformationsBenign Spinal TumorsChordoma
- Interventions
- Radiation: SBRT for Vertebral/Paraspinal MetastasesRadiation: SBRT for Benign Extradural Spine Tumors
- Registration Number
- NCT01347307
- Lead Sponsor
- Mercy Research
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SBRT for Vertebral/Paraspinal Metastases SBRT for Vertebral/Paraspinal Metastases Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy SBRT for Benign Extradural Spine Tumors SBRT for Benign Extradural Spine Tumors Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Mercy Medical Center, St. Louis
🇺🇸Saint Louis, Missouri, United States