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

Part of paid clinical trials in Miami, Florida.

Sponsor
Baptist Health South Florida
Study ID
NCT04802603
Status
Recruiting
Apply to this trial

Conditions

  • Metastasis Spine
  • Spine Metastases

Eligibility Criteria

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

Interventions

  • Spine stereotactic body radiotherapy — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Mar 14, 2021
Status verified
Nov 2025
Primary completion
Sep 28, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Radiotherapy
    Cohort 1 (De novo) No Prior radiotherapy Cohort 2 (Prior radiotherapy) Prior radiotherapy

Primary Outcome Measure

Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI) [ Time Frame: within 5 days of treatment completion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Miami Cancer Institute at Baptist Health, IncMiamiFlorida33176
Rupesh Kotecha, MD
[email protected]
786-596-2000
Rupesh Kotecha, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Miami Cancer Institute at Baptist Health, Inc· Miami, FL

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