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OpenTrials
Completed

NCT Number: NCT01347307

Stereotactic Body Radiotherapy for Spine Tumors

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria:

  • Patient age >= 18 years
  • 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

Treatment and study plan

SBRT for Benign Extradural Spine Tumors

Radiation

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)

Other names: Stereotactic Body Radiotherapy (SBRT)

SBRT for Vertebral/Paraspinal Metastases

Radiation

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)

Other names: Stereotactic Body Radiotherapy (SBRT)

Primary outcomes

  1. Initial Symptom Control

    Time frame: 6 weeks post-SBRT (or at first post-treatment follow-up)

    Evaluation of pain relief per patient report

  2. Local Tumor Recurrence Rate

    Time frame: (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 outcomes

  1. Late Toxicity Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mercy Research

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
May 4, 2011
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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