NCT04218617

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to establish the non-inferiority in vertebral compression fracture (VCF) incidence at 6 months between single-fraction and two-fraction sSRS. Other objectives are to to evaluate the 12-month impact of single- and two-fraction sSRS on local control (LC), pain control (PC), quality of life (QOL), and toxicity (specifically, pain flare, radiation esophagitis/laryngitis/pharyngitis, and radiation myelitis) This study is planned as a two-arm randomized phase II trial to establish non-inferiority of single fraction sSRS compared to two-fraction sSRS. Approximately 130 participants will be enrolled in this trial; 65 participants in each arm: * Group 1: If you are assigned to this group, you will undergo spine radiosurgery in a single (1) session. * Group 2: If you are assigned to this group, you will undergo spine radiosurgery in two (2) sessions.

Conditions

• Spine Metastases
• Spine Stereotactic Radiosurgery (sSRS)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-07
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2020-01-06
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study