Spine radiosurgery versus conventional radiation for spinal metastases
Official title: Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) Multicenter Randomized Phase II Clinical Trial
Run by University of Oklahoma · NCT05617716 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | University of Oklahoma Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Status | Recruiting |
| Started | September 9, 2025 |
| Main results expected | September 30, 2028 |
| Study ends | September 30, 2029 |
| Registry record updated | October 20, 2025 |
| Trial ID | NCT05617716 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States Recruiting -
Johns Hopkins University Hospitals
Baltimore, Maryland, United States Active not 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
MK-8294 for people with advanced metastatic solid tumors
This will try MK-8294, a targeted cancer drug, in people with advanced or metastatic solid tumors to find the highest dose that is safe and tolerable.
-
Biopsy-site marker stiffness in breast cancer
This observational study will see if the stiffness of biopsy-site markers relates to inflammation and potential spread in women with breast cancer.
-
Protoacoustic Imaging to See Radiation Delivery in Proton Therapy
This study tests radioacoustic imaging with ultrasound to help doctors see where proton therapy is delivering radiation for liver and prostate cancer patients.
-
Modified FOLFIRINOX with Pentamidine in Advanced Pancreatic Cancer
This study tests whether adding pentamidine to a modified FOLFIRINOX regimen helps people with advanced or metastatic pancreatic cancer.
-
Testing Alcohol Health Warning Labels for US Adults
A randomized online study will test different warning statements about alcohol and breast cancer risk among adult US women who drink or are young non-drinkers to see which warnings are most convincing.
-
Testing warning labels on cannabis packaging to see what design helps people notice risks
Researchers are testing different cannabis warning labels to see which designs make people notice health risks and think about their use more carefully.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.