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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT04218617
Phase
PHASE2
Status
Recruiting
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Conditions

  • Spine Metastases
  • Spine Stereotactic Radiosurgery (sSRS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diagnostic MRI — DEVICE
    Diagnostic MRI
  • Planning MRI — DEVICE
    Planning MRI: high definition (HD) MRI of the region of interest (1 vertebral level above and below the level(s) being treated)
  • Simulation CT — OTHER
    Simulation CT is obtained (1.5 mm slice thickness)
  • QOL assessment — OTHER
    QOL assessment
  • Brief pain inventory (BPI) — OTHER
    Brief pain inventory (BPI), including narcotic assessment
  • sSRS in 1 fraction — RADIATION
    sSRS 18 Gy in 1 fraction
  • sSRS in 2 fraction — RADIATION
    sSRS 24 Gy in 2 fractions to be delivered either on consecutive days or one day apart.

Study Details

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 Dates

Start date
Feb 7, 2020
Status verified
Jun 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 - Single fraction
    sSRS 18 Gy in 1 fraction
  • Active Comparator: Arm 2 - Two fraction
    sSRS 24 Gy in 2 fractions

Primary Outcome Measure

6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRS [ Time Frame: At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer CenterClevelandOhio44195
Samuel T. Chao, MD
[email protected]
866-223-8100

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By research site
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center· Cleveland, OH

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