Actively Recruiting
Spine Radiosurgery for Symptomatic Metastatic Neoplasms
Led by University of Oklahoma · Updated on 2025-10-20
240
Participants Needed
2
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to compare three types of radiation therapy for cancer that has spread to the spine. The two types of radiation therapy used in this trial are External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT). EBRT delivers tightly targeted radiation beams from outside the body. SBRT is a specialized type of radiation therapy that allows high doses of radiation to small targets. This study will include standard dose SBRT and higher dose SBRT. Each participant will be randomly assigned to either EBRT, standard dose SBRT, or higher dose SBRT.
CONDITIONS
Official Title
Spine Radiosurgery for Symptomatic Metastatic Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must have histologic confirmation of malignancy with spinal metastatic disease confirmed by imaging
- No prior therapies for this disease, including previous radiation therapy overlapping the spine treatment area
- Age greater than 18 years
- Life expectancy of at least 3 months as documented by the investigator
- Worst pain score less than 2 of 10 on the Brief Pain Inventory
- No intention to change pain medications on the first day of SBRT
- Spinal Instability score (SINS) less than or equal to 12
- Candidate for spine SBRT as determined by Radiation Oncology
- Ability and willingness to sign informed consent
You will not qualify if you...
- Receiving any other investigational agents
- Prognosis less than 3 months
- Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting compliance
- Pregnant or nursing
- Unable to receive MRI of the spine
- Spinal Instability in Neoplasia score (SINS) greater than or equal to 12
- Previous stereotactic radiosurgery overlapping the current treatment field
- More than 3 consecutive vertebral bodies in the SBRT treatment volume
- Not a candidate for SBRT per Radiation Oncology
- Known primary cancer with estimated median survival 3 months or less
- Unknown primary cancer
- Brief Pain Inventory score greater than 2
- Previous radiation therapy involving the intended SBRT treatment field
- Previous spinal surgery involving the SBRT target volume (biopsy excluded)
- Neurological deficits from malignant cauda equina or epidural spinal cord compression
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Johns Hopkins University Hospitals
Baltimore, Maryland, United States, 21287
Active, Not Recruiting
2
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73117
Actively Recruiting
Research Team
L
Lead Onco Nurse
CONTACT
S
Shearwood McClelland III, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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