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Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation

StatusActive, Not Recruiting
PhaseNot applicable
Started2020-05-22
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 4, 2025 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-02-03
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 80→confirmed 63
Study sitesdetails revised at 1 of 1 site
2024-09-04
Study Status v9
Primary completion date2024-08→2025-10
Completion date2026-05→2027-07
2023-12-26
Study Status v8
Re-verified, no change to tracked fields
2023-01-17
Study Status v7
Primary completion date2023-09-01→2024-08
Completion date2024-09-01→2026-05
2022-02-21
2 amendments v5-v6
2 re-verifications since 2021-04-01, no change to tracked fields
Show 4 earlier versions
2020-09-18
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-09-01→confirmed 2020-05-22
Study sitesdetails revised at 1 of 1 site
2020-05-18
Study Status v3
Primary completion date2030-09-01→2023-09-01
Completion date2031-09-01→2024-09-01
2020-05-11
Study Status, Arms and Interventions v2
InterventionsRadiation Therapy (Radiation), Radiofrequency Ablation (RAF) (Radiation)→Radiation Therapy (Radiation), Radiofrequency Ablation (RFA) (Radiation)
2020-05-05
Study Identification, Study Status v1
Study titlerevised
Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RAFRFA)/Vertebral Augmentation
2020-05-01
Original filing
The spread of cancer to the spine is referred to as spine metastasis. Spine metastases are a common complication of cancer and are frequently associated with significant back pain. This study is being done to help improve treatment for back pain caused by spinal metastases by comparing the effectiveness of two standard treatments. These two treatments include radiation therapy (RT) alone versus radiation therapy combined with radiofrequency ablation, with or without vertebral augmentation (PVA/RFA). In addition to RT or RT with PVA/RFA, will be continued with current pain medications.
Trial Details
NCT Number NCT04375891
Lead Sponsor Baptist Health South Florida
Collaborators: Medtronic
Conditions Oncology, Spine Metastases
Enrollment 63 participants
Start Date 2020-05-22
Primary Completion 2025-10 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2025-02-04