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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

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

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

NCT ID

NCT01347307

First Posted

May 2, 2011

Last Updated

June 17, 2020

Sponsor

Mercy Research

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

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

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

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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