RecruitingPhase 2NCT04218617

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


Sponsor

Case Comprehensive Cancer Center

Enrollment

130 participants

Start Date

Feb 7, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Brief pain inventory (BPI), a medical device called Diagnostic MRI, and others for people with spine metastases and spine stereotactic radiosurgery (ssrs). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDiagnostic MRI

Diagnostic MRI

DEVICEPlanning MRI

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

OTHERSimulation CT

Simulation CT is obtained (1.5 mm slice thickness)

OTHERQOL assessment

QOL assessment

OTHERBrief pain inventory (BPI)

Brief pain inventory (BPI), including narcotic assessment

RADIATIONsSRS in 1 fraction

sSRS 18 Gy in 1 fraction

RADIATIONsSRS 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

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NCT04218617


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