New combo therapy aims to strengthen spine and fight cancer spread
NCT ID NCT05178472
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is for people with cancer that has spread to the spine. It tests whether adding a procedure called vertebroplasty (which repairs broken spine bones) to standard radiation and immunotherapy can help prevent fractures and improve survival. About 200 participants will receive different combinations of these treatments. The goal is to find a better way to control the disease and maintain quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vertebroplasty (a procedure to repair broken spine bones) combined with stereotactic radiosurgery (precise radiation) and/or immunotherapy
- What this could lead to
- If successful, this could lead to a better standard treatment for spinal metastases that reduces fractures and improves survival and quality of life.
- What could go wrong
- This is an early-phase trial with no phase designation, so results are uncertain. The combination of procedures may increase risks like infection or nerve damage, and benefits may not be confirmed in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Dec 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: * At least 18 years of age and older with indeterminate Spine Metastasis. * All patients with histology that requires stereotactic RT as a part of their treatment. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Disease visualized by CT or MRI * Prior radiation therapy will be allowed at the discretion of the Radiation Oncologist based on current standard operating procedures. * Tumor tissue from the core biopsy or resected site of disease will be collected, if available for biomarker analyses. * Four or less consecutive spinal segments involved by tumor. Or four or less separate spinal tumor targets with a minimum of one vertebral body separation * Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaire in either English or Spanish. The baseline assessment must be completed within required timelines. Inability (illiteracy in English or Spanish, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible Exclusion Criteria: * Patients \< 18 years of age * Inability to get a standard MRI or CT myelogram for radiation treatment target delineation * Patients with prior radiation to the spinal segment to be treated may be included if the radiation dose can be delivered safely, per the treating radiation oncologist. * Patients with symptomatic spinal cord compression requiring emergent surgery * Pregnant or lactating women * Systemic therapy or immunosuppressive medications, excluding immunotherapy, within 3-14 days of radiation treatment, at the discretion of the treating radiation oncologist . * Patients with stable or unstable lesions based on SINS criteria
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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
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Ohio State University Comprehensive Cancer Center
RECRUITINGColumbus, Ohio, 43210, United States
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