Stereotactic Body Radiotherapy for Spine Tumors

June 17, 2020 updated by: Juli Mai, MD, Mercy Research

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Mercy Medical Center, St. Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: SBRT for Benign Extradural Spine Tumors
Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
Radiation: SBRT for Benign Extradural Spine Tumors
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)
Other: SBRT for Vertebral/Paraspinal Metastases
Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
Radiation: SBRT for Vertebral/Paraspinal Metastases
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial Symptom Control
Time Frame: 6 weeks post-SBRT (or at first post-treatment follow-up)
Evaluation of pain relief per patient report
6 weeks post-SBRT (or at first post-treatment follow-up)
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.
(1) At 1 year post-SBRT, (2) At patient's last follow-up or time of death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at patient's last follow-up (at least 3 months from treatment) or time of death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mercy Research

Investigators

  • Study Chair: Bethany Sleckman, MD, Mercy Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2008

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

May 2, 2011

First Submitted That Met QC Criteria

May 2, 2011

First Posted (Estimate)

May 4, 2011

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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