Spine Radiosurgery for Symptomatic Metastatic Neoplasms

NCT05617716 | Recruiting Phase 2

• 1 other identifier: OU-SCC-SPORTSMEN
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Metastatic Neoplasm to the Spine; Metastatic Neoplasm

Keywords

Radiosurgery; External Beam Radiation Therapy; Stereotactic Body Radiation Therapy; Spine Stereotactic Radiosurgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Proportion of patients who experienced 6-month pain freedom based on the BPI score

  6 months

• Local control actuarial rate at 6-months

  6 months

• Vertebral compression fracture rate at 6-months

  6 months

• Proportion of patients who experienced progression-free survival

  6 months

• Vertebral compression fracture rate at 12-months

  12 months

Study Arms (3)

Standard SBRT

EXPERIMENTAL

Participants will undergo standard dose Stereotactic Body Radiation Therapy as part of standard of care.

Radiation: Spine radiosurgery/stereotactic body radiation therapy standard dose

High Dose SBRT (SOC)

EXPERIMENTAL

Participants will undergo high dose Stereotactic Body Radiation Therapy as part of standard of care.

Radiation: Spine radiosurgery/stereotactic body radiation therapy high dose

Conventional EBRT (SOC)

EXPERIMENTAL

Participants will undergo External Beam Radiation Therapy as part of standard of care.

Radiation: Conventional external beam radiation therapy dose (EBRT)

Interventions

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.

Conventional EBRT (SOC)

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.

Standard SBRT

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.

High Dose SBRT (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (2)

Johns Hopkins University Hospitals

Baltimore, Maryland, 21287, United States

ACTIVE NOT RECRUITING

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 39930584 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.

  PMID: 37795393 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Shearwood McClelland III, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lead Onco Nurse

CONTACT

405-271-8777; SCC-IIT-Office@ouhsc.edu

Shearwood McClelland III, MD

CONTACT

405-271-3016; Shearwood-McClelland@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective phase II randomized trial to determine the optimal spine SBRT regimen for achieving pain freedom at 3 months.

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 15, 2022
• Study Start: September 9, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)