Spine radiation study aims to cut fracture risk
NCT ID NCT04218617
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study tests whether giving spine radiation in one session or two sessions better prevents bone fractures in people with cancer that has spread to the spine. About 130 adults with spine tumors will receive either one or two focused radiation treatments. The goal is to find which approach reduces fractures while still controlling pain and tumor growth.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2020
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
RECRUITINGCleveland, Ohio, 44195, United States
Contact Email: •••••@•••••
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Other studies related to the condition(s) this trial covers.
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- Heat and cement combo shows promise for spine cancer pain
- Could early radiation prevent spine fractures in cancer patients?
- MRI-Guided radiation aims to hit tumors harder, spare healthy tissue