Recruiting
Phase 2

EBRT, SBRT, Higher Dose

Sponsor:

University of Oklahoma

Code:

NCT05617716

Conditions

Metastatic Neoplasm to the Spine

Metastatic Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Conventional external beam radiation therapy dose (EBRT)

Spine radiosurgery/stereotactic body radiation therapy standard dose

Spine radiosurgery/stereotactic body radiation therapy high dose

Study Details

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

Study ID

NCT05617716

Start date

Sep 9, 2025

Status verified date

Oct, 2025

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Standard SBRT

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

experimental: High Dose SBRT (SOC)

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

experimental: Conventional EBRT (SOC)

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

Interventions

Conventional 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.

Spine 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.

Spine 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.

Primary outcome measure

  • Proportion of patients who experience 3-month pain freedom based on BPI score [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Lead Onco Nurse

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

Shearwood McClelland III, MD

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

Locations

OU Health Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73117

Contacts

Shearwood McClelland III, MD

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

More Information

Sponsor

University of Oklahoma

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2025-10-20.