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Radiation Therapy for Spinal Metastases

This study is comparing three types of radiation therapy for cancer that has spread to the spine (metastatic neoplasm to the spine). You would be randomly assigned to receive either conventional external beam radiation therapy (EBRT) or one of two doses of spine radiosurgery/stereotactic body radiation therapy (SBRT). The goal is to see which treatment is most effective at reducing pain and achieving pain freedom. To join, you must have cancer confirmed to have spread to your spine and not have received prior radiation therapy to that area. The study aims to enroll 240 participants, but its current recruitment status is unclear.

Study design
This is an interventional study where 240 participants will be randomly assigned to one of three treatment groups.
What's involved
You would receive one of three radiation treatments. You would also complete questionnaires at the start of the study and again at 3, 6, 9, and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after treatment, with pain assessed at 3 months as a primary goal.

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

NCT05617716

Spine Radiosurgery for Symptomatic Metastatic Neoplasms

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Oklahoma
~240 participants
Updated 2025-10-20 on ClinicalTrials.gov
What's tested:Conventional external beam radiation therapy dose (EBRT)Spine radiosurgery/stereotactic body radiation therapy standard doseSpine radiosurgery/stereotactic body radiation therapy high dose

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients who experience 3-month pain freedom based on BPI score
Measured over 3 months

Conditions

Metastatic Neoplasm to the Spine
Metastatic Neoplasm

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Metastatic Malignant Neoplasm in the Spine

NCT05617716

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahomastudy coordinator listed

    Recruiting

  • Johns Hopkins University Hospitals

    Baltimore, Marylandno site contact published

    Active, not 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

  • Shearwood McClelland III, MD · PRINCIPAL_INVESTIGATOR · University of Oklahoma

Who to contact

Lead Onco Nurse
[email protected]
405-271-8777
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Proportion of patients who experience 3-month pain freedom based on BPI score3 months

    Freedom from pain at 3 months defined as pain freedom following spine SBRT/EBRT per the Brief Pain Inventory (BPI), which is a scale of 1-10. The complete response for pain freedom is defined as a "worst" pain score of 0 on the BPI. Partial pain freedom is defined as a "worst" pain score of 2 points on the BPI.