Stereotactic Body Radiotherapy for Spine Tumors

Not Applicable

Completed

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

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

Inclusion Criteria

Not provided

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

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.

Locations (1): Mercy Medical Center, St. Louis
🇺🇸
Saint Louis, Missouri, United States
Mercy Medical Center, St. Louis
🇺🇸Saint Louis, Missouri, United States