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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard SBRT | Experimental | Participants will undergo standard dose Stereotactic Body Radiation Therapy as part of standard of care. |
|
| High Dose SBRT (SOC) | Experimental | Participants will undergo high dose Stereotactic Body Radiation Therapy as part of standard of care. |
|
| Conventional EBRT (SOC) | Experimental | Participants will undergo External Beam Radiation Therapy as part of standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional external beam radiation therapy dose (EBRT) | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who experienced 6-month pain freedom based on the BPI score | Freedom from pain at 6 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lead Onco Nurse | Contact | 405-271-8777 | SCC-IIT-Office@ouhsc.edu | |
| Shearwood McClelland III, MD | Contact | 405-271-3016 | Shearwood-McClelland@ouhsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shearwood McClelland III, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University Hospitals | Active, not recruiting | Baltimore | Maryland | 21287 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42302152 | Derived | 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. | |
| 39930584 | Derived | 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. |
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This is a prospective phase II randomized trial to determine the optimal spine SBRT regimen for achieving pain freedom at 3 months.
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| Spine radiosurgery/stereotactic body radiation therapy standard dose | Radiation | 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. |
|
| Spine radiosurgery/stereotactic body radiation therapy high dose | Radiation | 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. |
|
| Local control actuarial rate at 6-months | 6-month local control, defined as an actuarial 6-month rate of any new, recurrent or progressing (as defined by SPINOcriteria) tumor within the planning target volume on any post-treatment MRI by 6 months. Follow-up MRIs will be fused with the planning scan for this assessment | 6 months |
| Vertebral compression fracture rate at 6-months | 6-month vertebral compression fracture rate, assessed by post-treatment MRI by 6 months | 6 months |
| Proportion of patients who experienced progression-free survival | Overall participant survival | 6 months |
| Vertebral compression fracture rate at 12-months | 12-month vertebral compression fracture rate, assessed by post-treatment MRI at 12 months | 12 months |
| Perceived demographic disparities in patients at 3-month follow-up | Demographic disparities (by race, ethnicity, gender identity, sexual orientation, insurance status) following spine SBRT/EBRT access and outcomes at 3 months | 3 months |
| Perceived demographic disparities in patients at 6-month follow-up | Demographic disparities (by race, ethnicity, gender identity, sexual orientation, insurance status) following spine SBRT/EBRT access and outcomes at 6 months | 6 months |
| OU Health Stephenson Cancer Center |
| Recruiting |
| Oklahoma City |
| Oklahoma |
| 73117 |
| United States |
|
| 37795393 | Derived | 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. |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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