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NCT05617716: SPORTSMEN

Spine Radiosurgery for Symptomatic Metastatic Neoplasms

Recruiting now Phase 2 Last updated 20 October 2025
What this trial tests

Phase 2 trial testing Conventional external beam radiation therapy dose (EBRT) in Metastatic Neoplasm to the Spine in 240 participants. Currently enrolling.

Timeline
9 September 2025
Primary endpoint
30 September 2028
30 September 2029

Quick facts

Lead sponsorUniversity of Oklahoma
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment240
Start date9 September 2025
Primary completion30 September 2028
Estimated completion30 September 2029
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Oklahoma

Who can join

18 and older, any sex, with Metastatic Neoplasm to the Spine or Metastatic Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN): a randomized phase II study protocol.
    McClelland S, Sun Y, Spratt DE. · · 2023 · cited 10× · PMID 37795393 · DOI 10.5603/rpor.a2023.0037
  2. An Inpatient Metastatic Spine Neoplasm Score for assessing the appropriate modality of radiation therapy intervention.
    McClelland S. · · 2024 · cited 1× · PMID 39895961 · DOI 10.5603/rpor.101991
  3. Establishing a Protocol to Increase Racial/Ethnic Under-Represented Minority Enrollment on an Active Radiation Oncology Multicenter Randomized Clinical Trial.
    Gardner UG, Gardner UG, Brawley OW, Obi EE, et al · · 2025 · PMID 39930584 · DOI 10.1097/coc.0000000000001174
  4. Impact of National Comprehensive Cancer Network Guidelines Inclusion of Level 1 Evidence on Insurance Denial for Randomized Controlled Trial Patients with Metastatic Spine Disease.
    Gardner UG, Brately MM, Zuhour RJ, Sun Y, et al · · 2024 · PMID 39759561 · DOI 10.5603/rpor.102822

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05617716.

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