New study aims to find best radiation for spine cancer pain
NCT ID NCT05617716
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares three types of radiation therapy for cancer that has spread to the spine, with the goal of relieving pain. About 240 participants will be randomly assigned to receive either standard external beam radiation, standard-dose stereotactic body radiation, or higher-dose stereotactic body radiation. The main goal is to see which treatment provides the best pain relief at 3 and 6 months.
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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 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Sep 2029
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: * Participant must have histologic confirmation of malignancy. Spinal metastatic disease must be confirmed by imaging. * Participant must have received no prior therapies for this disease. Prior therapy includes previous radiation therapy encompassing the anatomic site to be treated with spine SBRT. This includes any previous radiation therapy where the treatment field overlaps with the anatomic site to be treated with spine SBRT (even if that previous radiation therapy was not for treatment of spinal disease). Systemic radiation therapy for metastatic disease such as Pluvicto also counts as previous radiation therapy. * Age \>18 years. This study requires informed consent by the participant; as children are not able to perform this without parental approval, Participant \< age 18 are excluded from this study. * Life expectancy of≥ 3 months, in the opinion of and as documented by the investigator. * Participant must have a worst pain score \< 2 of 10 according to the Brief Pain Inventory * Participant must have no intention of changing pain medications on the first day of SBRT * Participant must have a Spinal Instability score (SINS) ≤ 12 * Participant must be a spine SBRT candidate per Radiation Oncology * Participant must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Participant receiving any other investigational agents. * Participant with prognosis less than 3 months will be excluded from this clinical trial because of their poor prognosis and decreased likelihood to meet the primary endpoint * Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or nursing Participant are excluded due to toxicity of radiation therapy. * Participant is unable to receive MRI of the spine * Participant has a Spinal Instability in Neoplasia score (SINS) ≥ 12 * Participant has received previous stereotactic radiosurgery where the 50% isodose line overlaps with current treatment field * Participant has more than 3 consecutive vertebral bodies in the SBRT treatment volume * Participant is not an SBRT candidate per radiation oncology discretion * Participant has a known primary and has an estimated median survival≤ 3 months * Participant has an unknown primary * Participant has a Brief Pain Inventory score \> 2 * Participant has received previous radiation therapy involving the intended SBRT treatment field * Participant has received previous spinal surgical procedure involving the SBRT target volume. Biopsy is not considered a previous spinal surgical procedure. * Participant has neurological deficits from malignant cauda equina compression or epidural spinal cord compression
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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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Johns Hopkins University Hospitals
ACTIVE_NOT_RECRUITINGBaltimore, Maryland, 21287, United States
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OU Health Stephenson Cancer Center
RECRUITINGOklahoma City, Oklahoma, 73117, United States
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