Stereotactic Body Radiotherapy for Spine Tumors

Meningioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347307
• Other study ID #: 08-044
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: September 2017

Study information

• Verified date: June 2020
• Source: Mercy Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Benign Spinal Tumors
• Chordoma
• Meningioma
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Neurilemmoma
• Neurofibroma
• Paraganglioma
• Paragangliomas
• Schwannoma
• Spinal Cord Neoplasms
• Spinal Metastases
• Spinal Neoplasms
• Vertebral Metastases

Intervention

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)
• 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)

Locations

Country	Name	City	State
United States	Mercy Medical Center, St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial Symptom Control	Evaluation of pain relief per patient report	6 weeks post-SBRT (or at first post-treatment follow-up)
Primary	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	Late Toxicity Rate	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