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

PHASE2RecruitingINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

February 7, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
Spine MetastasesSpine 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.

Trial Locations (1)

44195

RECRUITING

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
lead

Case Comprehensive Cancer Center

OTHER