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

Study acronym: DESSRT
StatusRecruiting
PhaseNot applicable
Started2021-03-14
View on ClinicalTrials.gov ↗

Amendment history

2025-11-13
minor
Study Status v7
Primary completion date2025-12-31→2029-09-28
Completion date2026-12-31→2029-12-31
2024-10-17
minor
5 amendments v2-v6
5 re-verifications since 2022-04-11, no change to tracked fields
2021-07-13
minor
Study Status, Study Design, Outcome Measures v1
Secondary endpoints6 to 8 entries
Response to Pain relief Change in speed ofPain response to pain Change in response over time for the FACT-G Change in qualityresponse over time for the EQ-5D-5L Functional Assessment of lifeCancer responsesTherapy-General (FACT-G) EuroQol (EQ-5D-5L)
Primary endpoints1 to 3 entries
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI) Change in response to spine Stereotactic Body Radiotherapy (SBRT) for EQ-5D-5L Change in response to spine Stereotactic Body Radiotherapy (SBRT) for FACT-G
2021-03-15
minor
Original filing
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.
Trial Details
NCT Number NCT04802603
Lead Sponsor Baptist Health South Florida
Conditions Spine Metastases, Metastasis Spine
Enrollment 60 participants
Start Date 2021-03-14
Primary Completion 2029-09-28 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-14