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

NCT04218617 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-03-23

No results posted yet for this study

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.

Conditions

  • Spine Metastases
  • Spine Stereotactic Radiosurgery (sSRS)

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.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Samuel Chao, MD · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-07
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04218617 on ClinicalTrials.gov