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Comparing Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for Vertebral Metastases

This study is looking at two ways to deliver spine stereotactic radiosurgery (sSRS) for vertebral metastases (cancer that has spread to the spine). sSRS uses focused X-rays to treat the spine. We want to see if giving sSRS in one treatment session or two treatment sessions changes the chance of developing vertebral compression fractures (small breaks in the spinal bones) within 6 months. To join, you need to be at least 18 years old, have a good performance status (Karnofsky Performance Status or KPS of 70 or higher), and have vertebral metastases. The study aims to find out which approach is better at preventing these fractures, while also looking at pain control, quality of life, and side effects over 12 months. The current status of this study is unclear.

Study design
This is a randomized phase II study with two groups, aiming to enroll about 130 participants. You would be randomly assigned to receive spine radiosurgery in either one or two sessions.
What's involved
You would undergo diagnostic and planning MRIs, a simulation CT scan, and have your quality of life and pain assessed. These assessments would occur at baseline and then at 1, 3, 6, and 12 months after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after treatment to assess various outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04218617

Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases

Recruiting
PHASE2Ages 18+InterventionalTreatment
Case Comprehensive Cancer Center
~130 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Diagnostic MRIPlanning MRISimulation CTQOL assessmentBrief pain inventory (BPI)sSRS in 1 fraction

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRS
Measured over At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment)

Conditions

Spine Metastases
Spine Stereotactic Radiosurgery (sSRS)

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NCT04218617

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

    Cleveland, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Samuel Chao, MD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Who to contact

Samuel T Chao, MD
[email protected]
1-866-223-8100
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRSAt 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