Clinical trial NCT01347307: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Mercy Research
Sponsor class: OTHER
First posted: 2011-05-04
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Initial Symptom Control
timeFrame: 6 weeks post-SBRT (or at first post-treatment follow-up)
measure: Local Tumor Recurrence Rate
timeFrame: (1) At 1 year post-SBRT, (2) At patient's last follow-up or time of death
Secondary outcomes:
measure: Late Toxicity Rate
timeFrame: at patient's last follow-up (at least 3 months from treatment) or time of death
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Mercy Medical Center, St. Louis
state: Missouri
Study officials:
affiliation: Mercy Research
name: Bethany Sleckman, MD
role: STUDY_CHAIR
References: