Actively Recruiting
Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases
Led by Case Comprehensive Cancer Center · Updated on 2026-06-05
130
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating spine stereotactic radiosurgery (sSRS), a treatment that uses focused x-rays to target spinal metastases. This study aims to compare the effects of delivering sSRS in either one or two treatment sessions, focusing on how each approach affects the development of vertebral compression fractures (VCF), a common side effect. The trial is a phase II randomized study involving participants with vertebral metastases from cancer. Participants will be randomly assigned to one of two groups: one group will receive a single session of sSRS delivering 18 Gy, while the other will receive two sessions delivering a total of 24 Gy, either on consecutive days or one day apart. Both groups will undergo diagnostic and planning MRIs, as well as simulation CT scans to guide treatment. Quality of life and pain assessments will also be conducted throughout the study. During the study, participants will be monitored with MRIs and clinical evaluations at baseline, and at 1, 3, 6, and 12 months post-treatment. Researchers will assess vertebral compression fractures, local disease control, pain levels using the Brief Pain Inventory, quality of life via standardized questionnaires, and any treatment side effects. The total follow-up period will be up to 12 months to observe these outcomes and ensure participant safety.
CONDITIONS
Brief 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 class 2 (KPS >70 with uncontrolled systemic disease or KPS 6470, age 6554, 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 up to three separate sites with a maximum of two contiguous levels
- Radioresistant metastases (such as sarcomas, melanomas, renal cell carcinomas) are allowed
- Epidural disease allowed if no spinal cord compression
- Paraspinal extension permitted if 5 cm or less
- Multiple small metastatic lesions involving less than 20% of vertebral body allowed
- History and physical exam within four weeks before registration
- Negative pregnancy test within four weeks for women of childbearing potential
- Diagnostic spine MRI with and without contrast within four weeks before registration
- Neurological exam within four weeks to rule out rapid neurological decline; mild to moderate deficits allowed if lesion is 3 mm or more from spinal cord
- Prior external beam radiation therapy at the index site is allowed
- Informed consent provided
You will not qualify if you...
- Lesions located at C1-2 or S1-Coccyx
- Hematologic cancers including lymphoma and myeloma
- Multiple primary cancers
- Primary spinal tumors
- 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 for MRI or CT
- Emergent spinal cord compression
- Mechanical instability of the spine
- Active connective tissue disease
- Previous sSRS to the vertebrae targeted for treatment
- Diffuse or multilevel metastatic spinal disease involving over 20% of vertebral bodies or more than five vertebral levels
- Physical or mental limitations preventing participation
- Inability or unwillingness to attend all follow-up visits and imaging
- Inability to receive sSRS at prescribed doses and fractions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for history, physical exam, neurological exam, and diagnostic spine MRI
Duration - 1 to 2 days
Participants receive spine stereotactic radiosurgery (sSRS) either in a single session or two sessions depending on group assignment.
1 or 2 visits for radiosurgery sessions
Duration - 12 months
Participants undergo follow-up MRIs and assessments to monitor vertebral compression fracture incidence, local tumor control, pain, quality of life, and potential toxicities.
Follow-up visits with MRI and assessments at 1 month, 3 months, 6 months, and 12 months after treatment
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
E
Ehsan Balagamwala, MD
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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