Stereotactic Radiosurgery (SRS) for Spine Metastases
Stopped early · Not applicable
Conditions studied: Spinal Metastases
In brief
This study will evaluate the most effective radiation dose. Patients will be randomized (like flipping a coin) to receive either low dose stereotactic radiotherapy (defined as "14 Gy") or high dose stereotactic radiotherapy (defined as 18 Gy).
Key facts
- Study ID
- NCT00593320
- Run by
- Washington University School of Medicine
- People needed
- 2
- Starts
- 2007-09-01
- Expected to finish
- 2010-03-01
- Last updated by the study team
- 2015-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed informed consent.
- Age greater than or equal to 18 years old.
- Prior histologically-proven, non-hematogenous malignancy (Specific exclusions are multiple myeloma and lymphoma).
- Radiographic evidence of one or two non-contiguous spinal metastases amenable to SRS.
- Metastatic disease must be symptomatic (causing either pain or neurologic symptoms).
- Maximum tumor size less than or equal to 5 cm.
- Zubrod performance status of less than or equal to 3.
- Life expectancy of greater than or equal to 3 months.
- Women/Men of childbearing potential must use effective contraception.
You may not qualify if…
- No prior radiation delivered to the involved area
- No evidence of spinal instability requiring urgent surgical intervention.
- No evidence of spinal cord compression requiring emergent surgical or radiotherapeutic intervention.
- No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) while on this protocol except at disease progression.Concomitant is defined as within 3 days before or after radiosurgery.
- No pregnant or lactating women.
- No active systemic infection.
- No evidence of myelopathy or cauda equina syndrome on clinical evaluation
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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