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RECRUITING
NCT04218617
PHASE2

Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases

Sponsor: Case Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and/or neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be treated and away from normal tissue. One of the side effects of spine SRS is the development of vertebral compression fractures, many of which are not painful. The goal of this study is to compare the effects, good and/or bad, of spine SRS given in 1 or 2 treatments. Our main goal is to find out which approach will reduce the chances of developing vertebral compression fractures.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2020-02-07

Completion Date

2026-10

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

DEVICE

Diagnostic MRI

Diagnostic MRI

DEVICE

Planning MRI

Planning MRI: high definition (HD) MRI of the region of interest (1 vertebral level above and below the level(s) being treated)

OTHER

Simulation CT

Simulation CT is obtained (1.5 mm slice thickness)

OTHER

QOL assessment

QOL assessment

OTHER

Brief pain inventory (BPI)

Brief pain inventory (BPI), including narcotic assessment

RADIATION

sSRS in 1 fraction

sSRS 18 Gy in 1 fraction

RADIATION

sSRS in 2 fraction

sSRS 24 Gy in 2 fractions to be delivered either on consecutive days or one day apart.

Locations (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States