NCT04218617 · Case Comprehensive Cancer Center
Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases
What this study 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.
View original scientific description
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.
Interventions
DEVICE
Diagnostic MRI
Diagnostic MRI
DEVICE
Planning MRI
Planning MRI: high definition (HD) MRI of the region of interest (1 vertebral level above and below the level(s) being treated)
OTHER
Simulation CT
Simulation CT is obtained (1.5 mm slice thickness)
OTHER
QOL assessment
QOL assessment
OTHER
Brief pain inventory (BPI)
Brief pain inventory (BPI), including narcotic assessment
RADIATION
sSRS in 1 fraction
sSRS 18 Gy in 1 fraction
RADIATION
sSRS in 2 fraction
sSRS 24 Gy in 2 fractions to be delivered either on consecutive days or one day apart.
Primary outcome measures
6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRS
Time frame: At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment)
6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRS Each treated vertebra will be assessed individually for VCF during radiologic follow-up
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Karnofsky Performance Status (KPS) ≥ 70
- RPA class 1 (KPS \>70 AND controlled systemic disease) or RPA Class 2 (KPS \>70, uncontrolled systemic disease OR KPS ≤70, age ≥54, no visceral metastases)44 (see Appendix II)
- Vertebral metastases from C3 to L5 based on bone scan, CT, PET, or MRI.
- Vertebral metastases must be (1) solitary, (2) at two contiguous levels, or (3) a maximum of three separate sites, with a maximum of two contiguous levels.
- Radioresistant metastases are permitted (including sarcomas, melanomas, and renal cell carcinomas).
- Patients with epidural disease are permitted so long as there is no cord compression.
- Paraspinal extension is permitted, so long as the paraspinal component is ≤5 cm
- Multiple small metastatic lesions (\<20% vertebral body involvement) of no clinical correlate are permitted, and not included in the irradiated segments as per RTOG 0631
- History and physical within four weeks of registration.
- Negative pregnancy test within four weeks of registration for women of childbearing potential.
- Diagnostic spine MRI with and without contrast within four weeks of registration
- Neurological exam within four weeks of registration to rule out rapid neurological decline. Mild to moderate neurological deficits are acceptable, as long as distance between lesion and spinal cord is ≥3 mm
- Patients may have prior EBRT at the index site.
- Informed consent of the participant.
Exclusion criteria
- Lesions at C1-2 or S1-Coccyx.
- Hematologic malignancies including lymphoma and myeloma.
- Multiple primary cancers.
- Primary neoplasms of the spine
- Prior corpectomy, kyphoplasty/vertebroplasty, or instrumentation at the site of planned sSRS.
- Spinal cord compression.
- Paraspinal mass \>5 cm.
- Patients with rapid neurologic decline.
- Bony retropulsion resulting in neurologic deficit.
- Patients with contraindications to MRI.
- Patients allergic to intravenous contrast for MRI or CT.
- Patients with emergent spinal cord compression.
- Patients with mechanical instability of the spine.
- Patients with active connective tissue disease.
- Patients who previously underwent sSRS to the vertebrae of interest.
- Patients with diffuse or multilevel metastatic spinal disease with \>20% involvement of vertebral bodies, defined as involvement of \>5 vertebral levels.
- Inability to participate in study activities due to physical or mental limitations.
- Inability or unwillingness to return for all required follow-up visits and imaging.
- Inability to deliver sSRS, either 18 Gy in one fraction, or 24 Gy in two fractions.
Where
- Cleveland, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2026 · Source of record for eligibility and locations