Clinical trial · Interventional
Spine Radiosurgery for Symptomatic Metastatic Neoplasms
Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) Multicenter Randomized Phase II Clinical Trial
NCT05617716CI-TRIAL-00096631SPORTSMENrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare three types of radiation therapy for cancer that has spread to the spine. The two types of radiation therapy used in this trial are External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT). EBRT delivers tightly targeted radiation beams from outside the body. SBRT is a specialized type of radiation therapy that allows high doses of radiation to small targets. This study will include standard dose SBRT and higher dose SBRT. Each participant will be randomly assigned to either EBRT, standard dose SBRT, or higher dose SBRT.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Neoplasm | Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Neoplasm to the Spine | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional external beam radiation therapy dose (EBRT) | Radiation | — | UNRESOLVED |
| Spine radiosurgery/stereotactic body radiation therapy high dose | Radiation | — | UNRESOLVED |
| Spine radiosurgery/stereotactic body radiation therapy standard dose | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Standard SBRT
- description
- Participants will undergo standard dose Stereotactic Body Radiation Therapy as part of standard of care.
- interventionNames
- Radiation: Spine radiosurgery/stereotactic body radiation therapy standard dose
- type
- EXPERIMENTAL
- label
- High Dose SBRT (SOC)
- description
- Participants will undergo high dose Stereotactic Body Radiation Therapy as part of standard of care.
- interventionNames
- Radiation: Spine radiosurgery/stereotactic body radiation therapy high dose
- type
- EXPERIMENTAL
- label
- Conventional EBRT (SOC)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDOboh EC, Anwar M, Perry L, Cleaver N, McClelland S 3rd. Early Economic and Patient-Centered Outcomes Before Spine Metastases Radiation Therapy From an Ongoing Phase II Randomized Controlled Trial. Am J Clin Oncol. 2026 Jun 16. doi: 10.1097/COC.0000000000001346. Online ahead of print. PMID 42302152
- DERIVEDGardner UG Jr, Brawley OW, Obi EE, Redmond KJ, McClelland S 3rd. Establishing a Protocol to Increase Racial/Ethnic Under-Represented Minority Enrollment on an Active Radiation Oncology Multicenter Randomized Clinical Trial. Am J Clin Oncol. 2025 Jun 1;48(6):310-313. doi: 10.1097/COC.0000000000001174. Epub 2025 Feb 11. PMID 39930584
- DERIVEDMcClelland S 3rd, Sun Y, Spratt DE. Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN): a randomized phase II study protocol. Rep Pract Oncol Radiother. 2023 Jul 25;28(3):379-388. doi: 10.5603/RPOR.a2023.0037. eCollection 2023. PMID 37795393