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Stereotactic Body Radiotherapy for Spine Tumors

Not Applicable
Completed
Conditions
Spinal Metastases
Vertebral Metastases
Meningioma
Schwannoma
Neurofibroma
Paragangliomas
Arteriovenous Malformations
Benign Spinal Tumors
Chordoma
Interventions
Radiation: SBRT for Vertebral/Paraspinal Metastases
Radiation: 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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
SBRT for Vertebral/Paraspinal MetastasesSBRT for Vertebral/Paraspinal MetastasesVertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
SBRT for Benign Extradural Spine TumorsSBRT for Benign Extradural Spine TumorsBenign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
Primary Outcome Measures
NameTimeMethod
Initial Symptom Control6 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
NameTimeMethod
Late Toxicity Rateat 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

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