Stereotactic Body Radiotherapy for Spine Tumors

NCT01347307 | Completed Results

• 1 other identifier: 08-044
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Metastases; Vertebral Metastases; Benign Spinal Tumors; Chordoma; Meningioma; Schwannoma; Neurofibroma; Paragangliomas; Arteriovenous Malformations

Keywords

stereotactic radiotherapy; spinal metastases; vertebral metastases; benign spinal tumors

Outcome Measures

Primary Outcomes (2)

• Initial Symptom Control

  Evaluation of pain relief per patient report

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

• 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.

  (1) At 1 year post-SBRT, (2) At patient's last follow-up or time of death

Secondary Outcomes (1)

• Late Toxicity Rate

  at patient's last follow-up (at least 3 months from treatment) or time of death

Study Arms (2)

SBRT for Benign Extradural Spine Tumors

OTHER

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

Radiation: SBRT for Benign Extradural Spine Tumors

SBRT for Vertebral/Paraspinal Metastases

OTHER

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

Radiation: SBRT for Vertebral/Paraspinal Metastases

Interventions

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)

Also known as: Stereotactic Body Radiotherapy (SBRT)

SBRT for Benign Extradural Spine Tumors

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)

Also known as: Stereotactic Body Radiotherapy (SBRT)

SBRT for Vertebral/Paraspinal Metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mercy Research: lead

Study Sites (1)

Mercy Medical Center, St. Louis

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Chordoma; Meningioma; Neurilemmoma; Neurofibroma; Paraganglioma; Arteriovenous Malformations

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neuroma; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Lead Regulatory Coordinator - Investigator Initiated Trials
• Organization: Mercy Research

michelle.mcfarland@mercy.net

314-251-8827

Study Officials

• Bethany Sleckman, MD

  Mercy Research

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncology

Study Record Dates

• First Submitted: May 2, 2011
• First Posted: May 4, 2011
• Study Start: September 1, 2008
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 18, 2020
• Results First Posted: June 18, 2020

Record last verified: 2020-06

Locations

US (1)