Actively Recruiting
Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases
Led by Case Comprehensive Cancer Center · Updated on 2026-03-23
130
Participants Needed
1
Research Sites
346 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and/or neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be treated and away from normal tissue. One of the side effects of spine SRS is the development of vertebral compression fractures, many of which are not painful. The goal of this study is to compare the effects, good and/or bad, of spine SRS given in 1 or 2 treatments. Our main goal is to find out which approach will reduce the chances of developing vertebral compression fractures.
CONDITIONS
Official Title
Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Karnofsky Performance Status (KPS) of 70 or higher
- RPA class 1 (KPS >70 and controlled systemic disease) or RPA class 2 (KPS >70 with uncontrolled systemic disease or KPS 64 70, age 64 54, no visceral metastases)
- Vertebral metastases from C3 to L5 confirmed by bone scan, CT, PET, or MRI
- Metastases must be solitary, at two contiguous levels, or a maximum of three separate sites with up to two contiguous levels
- Radioresistant metastases allowed, including sarcomas, melanomas, and renal cell carcinomas
- Epidural disease allowed if no spinal cord compression
- Paraspinal extension allowed if 64 5 cm
- Multiple small metastatic lesions (C20% vertebral body involvement) permitted if not included in radiation target
- History and physical exam within four weeks before registration
- Negative pregnancy test within four weeks before registration for women who can become pregnant
- Diagnostic spine MRI with and without contrast within four weeks before registration
- Neurological exam within four weeks before registration showing no rapid neurological decline and lesion at least 3 mm from spinal cord
- Prior external beam radiation therapy at the treatment site allowed
- Informed consent provided
You will not qualify if you...
- Lesions at vertebrae C1-2 or S1-Coccyx
- Hematologic cancers such as lymphoma and myeloma
- Multiple primary cancers
- Primary tumors of the spine
- Prior corpectomy, kyphoplasty, vertebroplasty, or instrumentation at planned treatment site
- Spinal cord compression
- Paraspinal mass larger than 5 cm
- Rapid neurological decline
- Bony retropulsion causing neurological deficit
- Contraindications to MRI
- Allergy to intravenous contrast used for MRI or CT
- Emergent spinal cord compression
- Mechanical instability of the spine
- Active connective tissue disease
- Previous sSRS to the vertebrae being treated
- Diffuse or multilevel spinal metastatic disease involving more than 20% of vertebral bodies or more than 5 vertebral levels
- Physical or mental limitations preventing study participation
- Inability or unwillingness to return for all follow-up visits and imaging
- Inability to deliver 18 Gy in one fraction or 24 Gy in two fractions of sSRS
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
S
Samuel T Chao, MD
CONTACT
E
Ehsan Balagamwala, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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