Could early radiation prevent spine fractures in cancer patients?
NCT ID NCT05534321
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving radiation early to spine tumors that are not yet painful can prevent serious problems like fractures or spinal cord compression. About 74 adults with cancer that has spread to the spine will receive radiation before symptoms get worse. The goal is to reduce the need for emergency treatment and improve quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2022
- Expected to finish
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Sep 2027
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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically-confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging. 2. Has high-risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risk metastases are defined as: 1. Bulkiest sites of spinal osseous disease ≥ 2cm, 2. Disease at junctional levels, including the thoracic apex (Occiput to C2, C7-T1, T12-L2, and L5- S1) 3. Disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints. 4. Vertebral body compression deformity \> 50%. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2. 4. Age ≥ 18 years. 5. Able to provide informed consent. 6. Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating. Exclusion Criteria: 1. Previous RT to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances. 2. Serious medical co-morbidities precluding RT. 3. Pregnant or lactating women. 4. Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture. 5. Leptomeningeal disease. 6. Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.
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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 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
Locations
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Miami Cancer Institute at Baptist Health South Florida
RECRUITINGMiami, Florida, 33176, United States
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