NCT04218617|RecruitingPhase 2FDA Device
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Sponsor study identifier
interventional
130
1 country
1
Study Start
February 7, 2020
Actual (reported)Primary Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2, 2020
Actual (reported)January 6, 2020
Actual (reported)February 7, 2020
Actual (reported)October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRS
6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRS Each treated vertebra will be assessed individually for VCF during radiologic follow-up
At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment)
Local control (LC) as defined as absence of local progression of disease In the event of disease progression, all cases will be reviewed at the multi-disciplinary spine tumor board for a consensus recommendation
At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment)
Pain control (PC) as assessed by the Brief Pain Inventory (BPI)
At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment)
Quality of life (QOL) assessed by EORTC QLQ-C30 (with BM22)
At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment)
Toxicity as assessed by CTCAE V. 5.0
At follow-up MRI (1 month, 3 months, 6 months and 12 months after treatment)
sSRS 18 Gy in 1 fraction
sSRS 24 Gy in 2 fractions
Diagnostic MRI
Planning MRI: high definition (HD) MRI of the region of interest (1 vertebral level above and below the level(s) being treated)
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195, United States
Samuel Chao, MD
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
First Submitted
January 2, 2020
First Posted
January 6, 2020
Study Start
February 7, 2020
Actual (reported)Primary Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column
Simulation CT is obtained (1.5 mm slice thickness)
QOL assessment
Brief pain inventory (BPI), including narcotic assessment
sSRS 18 Gy in 1 fraction
sSRS 24 Gy in 2 fractions to be delivered either on consecutive days or one day apart.
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Study Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 6, 2026
Record last verified: 2026-08
All IPD that underlie results in publication, after de-identification
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Source: ClinicalTrials.gov.
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