Stereotactic Body Radiotherapy for Spine Tumors (NCT01347307) | Clinical Trial Compass
CompletedNot Applicable
Stereotactic Body Radiotherapy for Spine Tumors
United States38 participantsStarted 2008-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cor…
What they're measuring
1
Initial Symptom Control
Timeframe: 6 weeks post-SBRT (or at first post-treatment follow-up)
2
Local Tumor Recurrence Rate
Timeframe: (1) At 1 year post-SBRT, (2) At patient's last follow-up or time of death