Spine radiosurgery versus conventional radiation for spinal metastases
Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) Multicenter Randomized Phase II Clinical Trial
This trial tests three radiation approaches—single‑fraction external beam radiation, single‑fraction SBRT, and two‑fraction higher‑dose SBRT—to see which best reduces pain for adults with cancer that has spread to the spine.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT05617716 on ClinicalTrials.gov |
What this trial studies
This randomized phase 2 trial assigns adults with confirmed spinal metastases in a 1:1:1 ratio to conventional EBRT (8 Gy in 1 fraction), SBRT 19 Gy in 1 fraction, or SBRT 24 Gy in 2 fractions. Key eligibility includes histologic confirmation of malignancy, imaging-proven spine metastasis, no prior radiation overlapping the treatment site, age ≥18, and an expected survival of at least three months. Participants complete patient-reported outcome measures (Brief Pain Inventory, COST-FACIT, and EQ-5D) at baseline and during 3–12 month follow-up to compare pain relief durability and quality of life. The trial tests whether standard or higher-dose SBRT provides more durable pain control than conventional single‑fraction EBRT.
Who should consider this trial
Good fit: Adults with histologically confirmed cancer and imaging-proven spinal metastases who have not had prior radiation overlapping the planned treatment site and who are expected to survive at least three months.
Not a fit: Patients who previously received overlapping radiation to the target spine level, those with a very short expected survival, or those with contraindications to SBRT/EBRT may not receive benefit from this trial.
Why it matters
Potential benefit: If successful, the study could identify a radiation approach that provides longer-lasting pain relief and reduces the need for repeat treatments for people with spine metastases.
How similar studies have performed: Non-randomized series and some randomized data suggest SBRT can improve local control and more durable pain relief compared with conventional EBRT, but head-to-head randomized comparisons of specific dose regimens are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland and 1 other locations
- Johns Hopkins University Hospitals — Baltimore, Maryland, United States (Active_not_recruiting)
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Shearwood McClelland III, MD — University of Oklahoma
- Study coordinator: Lead Onco Nurse
- Email: SCC-IIT-Office@ouhsc.edu
- Phone: 405-271-8777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.