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RECRUITING
NCT04802603
NA

Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column

Sponsor: Baptist Health South Florida

View on ClinicalTrials.gov

Summary

This study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques. In standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. When this treatment is delivered in only 1-2 treatments, a high dose is used which can increase the side effects of treatment. This study aims to test an alternative technique of delivering SSRS over 5 treatments. By delivering the radiation therapy over multiple treatments, the dose of radiation is less per treatment.

Official title: Dose-Escalated Spine SbRT (DESSRT) for Localized Metastasis to the Spinal Column

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2021-03-14

Completion Date

2029-12-31

Last Updated

2025-11-14

Healthy Volunteers

No

Interventions

RADIATION

Spine stereotactic body radiotherapy

Cohort 1 - De novo: Spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions. Cohort 2 - Prior radiotherapy: Risk-adapted spinal cord tolerance based on prior spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions.

Locations (1)

Miami Cancer Institute at Baptist Health, Inc

Miami, Florida, United States