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RECRUITING
NCT05617716
PHASE2

Spine Radiosurgery for Symptomatic Metastatic Neoplasms

Sponsor: University of Oklahoma

View on ClinicalTrials.gov

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.

Official title: Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) Multicenter Randomized Phase II Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2025-09-09

Completion Date

2029-09-30

Last Updated

2025-10-20

Healthy Volunteers

No

Interventions

RADIATION

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.

RADIATION

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.

RADIATION

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.

Locations (2)

Johns Hopkins University Hospitals

Baltimore, Maryland, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States