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Stereotactic Body Radiotherapy for Spine Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. John's Mercy Research Institute, St. Louis
ClinicalTrials.gov Identifier:
NCT01347307
First received: May 2, 2011
Last updated: June 7, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Spinal Metastases
Vertebral Metastases
Benign Spinal Tumors
Chordoma
Meningioma
Schwannoma
Neurofibroma
Paragangliomas
Arteriovenous Malformations
 Radiation: stereotactic body radiotherapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Spine Metastases and Primary Spine Tumors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. John's Mercy Research Institute, St. Louis:

Primary Outcome Measures:
  • symptom control [ Time Frame: 6 weeks post RT ] [ Designated as safety issue: No ]

    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.


  • local tumor recurrence rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    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:
  • late toxicity rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Toxicity will be assessed using CTCAE grading criteria at specified timepoints.


Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
benign extradural spine tumors
Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
 Radiation: stereotactic body radiotherapy
12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
Vertebral and/or paraspinal metastases
Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
 Radiation: stereotactic body radiotherapy
14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347307

Locations
United States, Missouri
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
Sponsors and Collaborators
St. John's Mercy Research Institute, St. Louis
  More Information

No publications provided

Responsible Party: St. John's Mercy Research Institute, St. Louis
ClinicalTrials.gov Identifier: NCT01347307     History of Changes
Other Study ID Numbers: 08-044
Study First Received: May 2, 2011
Last Updated: June 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by St. John's Mercy Research Institute, St. Louis:
stereotactic radiosurgery
spinal metastases
vertebral metastases
benign spinal tumors

Additional relevant MeSH terms:
Congenital Abnormalities
Arteriovenous Malformations
Aneurysm
Hemangioma
Chordoma
Meningioma
Neoplasm Metastasis
Neoplasms, Second Primary
Neurilemmoma
Neurofibroma
Paraganglioma
Spinal Cord Neoplasms
Spinal Neoplasms
Vascular Malformations
Cardiovascular Abnormalities
 Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Neoplastic Processes
Pathologic Processes
Neuroendocrine Tumors

ClinicalTrials.gov processed this record on June 18, 2013