Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) Multicenter Randomized Phase II Clinical Trial
Summary
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.
Detailed description
Metastatic spine cancer incidence is increasing; the primary treatment is radiation therapy. Metastatic spine disease has been historically treated with external beam radiation therapy (EBRT) with conventional fractionation, yielding relatively limited durability in pain control. The increased lifespan of patients with metastatic cancer has resulted in an increase in the incidence of spine metastases, which has led to a need for more durable treatment results. Stereotactic radiosurgery (SRS)/Stereotactic body radiation therapy (SBRT) of the spine has exponentially increased, with the theoretical advantages of higher tumoricidal dose and more rapid fall off between tumor and surrounding normal tissue compared with EBRT. The goal of this study is to compare three types of radiation therapy to draw conclusions on what is an effective treatment to reduce pain and increase pain freedom rates. Patients in this trial will be randomized in a 1:1:1 ratio into one of three treatment arms: SBRT (24 Gy in 2 fractions), SBRT (19 Gy in 1 fraction), or conventional EBRT (8 Gy in 1 fraction). Participants will complete three questionnaires-the Brief Pain Inventory, COST-FACIT, and EuroQol EQ-5D-at baseline and again during the 3- to 12-month follow-up period.
Arms & interventions
- RadiationConventional external beam radiation therapy dose (EBRT)
Participants will undergo 8 Gray in 1 fraction of EBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up.
- RadiationSpine radiosurgery/stereotactic body radiation therapy standard dose
Participants will undergo 24 Gray in 2 fractions of SBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up.
- RadiationSpine radiosurgery/stereotactic body radiation therapy high dose
Participants will undergo 19 Gray in 1 fraction of SBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up.
Outcome measures
Primary
Proportion of patients who experience 3-month pain freedom based on BPI score
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.
Time frame: 3 months
Secondary
Proportion of patients who experienced 6-month pain freedom based on the BPI score
Time frame: 6 months
Local control actuarial rate at 6-months
Time frame: 6 months
Vertebral compression fracture rate at 6-months
Time frame: 6 months
Proportion of patients who experienced progression-free survival
Time frame: 6 months
Vertebral compression fracture rate at 12-months
Time frame: 12 months
Perceived demographic disparities in patients at 3-month follow-up
Time frame: 3 months
Perceived demographic disparities in patients at 6-month follow-up
Time frame: 6 months
Eligibility criteria
Study locations (2)
Johns Hopkins University Hospitals
Baltimore, Maryland, 21287
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73117
References
- Oboh 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.(PubMed)
- Gardner 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.(PubMed)
- McClelland 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.(PubMed)