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

Phase 4
18 Years
Open (Enrolling)
Spinal Metastases, Vertebral Metastases, Benign Spinal Tumors, Chordoma, Meningioma, Schwannoma, Neurofibroma, Paragangliomas, Arteriovenous Malformations

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Trial Information

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

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

Follow up data will be collected during the patient's standard office visits. The
anticipated duration of this study is 5 years

Inclusion Criteria

Eligibility Criteria:

- Patient age >= 18 years

- Zubrod 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

symptom control

Outcome Description:

Evaluation of pain relief will be assessed using a 10-point visual analog scale. Analgesic use will be documented to ensure that pain improvement is not due to an increase in the amount of analgesic usage. Evaluation of neurologic improvement will be assessed by physical exam using the ASIA Impairment Scale.

Outcome Time Frame:

6 weeks post RT

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

September 2008

Completion Date:

September 2015

Related Keywords:

  • Spinal Metastases
  • Vertebral Metastases
  • Benign Spinal Tumors
  • Chordoma
  • Meningioma
  • Schwannoma
  • Neurofibroma
  • Paragangliomas
  • Arteriovenous Malformations
  • stereotactic radiosurgery
  • spinal metastases
  • vertebral metastases
  • benign spinal tumors
  • Congenital Abnormalities
  • Arteriovenous Malformations
  • Aneurysm
  • Hemangioma
  • Chordoma
  • Meningioma
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Neurilemmoma
  • Neurofibroma
  • Paraganglioma
  • Spinal Cord Neoplasms
  • Spinal Neoplasms



St. John's Mercy Medical Center Saint Louis, Missouri  63141