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Stereotactic Body Radiotherapy for Spine Tumors

Primary Purpose

Spinal Metastases, Vertebral Metastases, Benign Spinal Tumors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SBRT for Benign Extradural Spine Tumors
SBRT for Vertebral/Paraspinal Metastases
Sponsored by
Mercy Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Metastases focused on measuring stereotactic radiotherapy, spinal metastases, vertebral metastases, benign spinal tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mercy Medical Center, St. Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

SBRT for Benign Extradural Spine Tumors

SBRT for Vertebral/Paraspinal Metastases

Arm Description

Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).

Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy

Outcomes

Primary Outcome Measures

Initial Symptom Control
Evaluation of pain relief per patient report
Local Tumor Recurrence Rate
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
Toxicity will be assessed using CTCAE grading criteria at specified timepoints.

Full Information

First Posted
May 2, 2011
Last Updated
June 17, 2020
Sponsor
Mercy Research
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1. Study Identification

Unique Protocol Identification Number
NCT01347307
Brief Title
Stereotactic Body Radiotherapy for Spine Tumors
Official Title
Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Spine Metastases and Primary Spine Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 2008 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mercy Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Metastases, Vertebral Metastases, Benign Spinal Tumors, Chordoma, Meningioma, Schwannoma, Neurofibroma, Paragangliomas, Arteriovenous Malformations
Keywords
stereotactic radiotherapy, spinal metastases, vertebral metastases, benign spinal tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBRT for Benign Extradural Spine Tumors
Arm Type
Other
Arm Description
Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
Arm Title
SBRT for Vertebral/Paraspinal Metastases
Arm Type
Other
Arm Description
Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
Intervention Type
Radiation
Intervention Name(s)
SBRT for Benign Extradural Spine Tumors
Other Intervention Name(s)
Stereotactic Body Radiotherapy (SBRT)
Intervention Description
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)
Intervention Type
Radiation
Intervention Name(s)
SBRT for Vertebral/Paraspinal Metastases
Other Intervention Name(s)
Stereotactic Body Radiotherapy (SBRT)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Initial Symptom Control
Description
Evaluation of pain relief per patient report
Time Frame
6 weeks post-SBRT (or at first post-treatment follow-up)
Title
Local Tumor Recurrence Rate
Description
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.
Time Frame
(1) At 1 year post-SBRT, (2) At patient's last follow-up or time of death
Secondary Outcome Measure Information:
Title
Late Toxicity Rate
Description
Toxicity will be assessed using CTCAE grading criteria at specified timepoints.
Time Frame
at patient's last follow-up (at least 3 months from treatment) or time of death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bethany Sleckman, MD
Organizational Affiliation
Mercy Research
Official's Role
Study Chair
Facility Information:
Facility Name
Mercy Medical Center, St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States

12. IPD Sharing Statement

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Stereotactic Body Radiotherapy for Spine Tumors

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