Focused high-dose SBRT for spinal tumors
Official title: Program SBRT Technique Implementation in Spinal Metastases Irradiation
Run by Institute of Oncology Ljubljana · NCT07429422 · Data updated 2026-11-12
This program will try focused high-dose SBRT for adults with spinal metastases to track side effects and local tumor control during routine care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Locations | 2 sites (Ljubljana and 1 other locations) |
| Status | Recruiting |
| Started | November 1, 2021 |
| Main results expected | December 31, 2022 |
| Study ends | December 31, 2026 |
| Registry record updated | February 24, 2026 |
| Trial ID | NCT07429422 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with spinal metastases who meet the institute's SBRT spine protocol and can undergo CT simulation, immobilization, and image-guided radiotherapy are ideal candidates.
✕Probably not a fit
Patients needing urgent surgical intervention, unable to tolerate SBRT positioning or immobilization, or with other medical contraindications to safe SBRT delivery are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The Institute of Oncology Ljubljana implemented spinal SBRT in 2017 and introduced an institutional SBRT spine protocol in 2019 to standardize care. This program supports structured implementation and continuous development of that protocol through prospective peer review of target delineation and treatment plans, staff education, and ongoing quality assurance, with possible retrospective plan review for consistency. All enrolled patients receive SBRT per the institutional protocol and are followed with routine clinical visits and radiological imaging, while toxicity is recorded using CTCAE criteria. Collected data are anonymized and no additional interventions beyond standard SBRT and follow-up are required for participation.
Why it matters
Potential benefit: If successful, the program could improve local tumor control and patient safety by standardizing SBRT planning and delivery across the clinic.
How similar studies have gone: Randomized and observational studies have shown SBRT can achieve higher local control than conventional radiotherapy for spinal metastases, and structured implementation with peer review and QA follows recognized best practices though program-level outcome reports are less common.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥18 years) with spinal metastases or spinal tumors referred for stereotactic body radiotherapy (SBRT). * Patients eligible for SBRT treatment according to the institutional SBRT spine protocol. * Ability to undergo CT simulation, immobilization, and image-guided radiotherapy procedures. Exclusion Criteria: * Inability to tolerate SBRT positioning or immobilization. * Clinical situations requiring urgent surgical intervention or alternative treatment. * Other medical conditions that prevent safe SBRT delivery.
Where it's running
-
Institute of Oncology
Ljubljana, Slovenia Recruiting -
Institute of Oncology Ljubljana
Ljubljana, Slovenia Recruiting
Study contacts
- Study coordinator: Jasna But Hadžić, MD
- Email: jbut@onko-i.si
- Phone: +38615879648
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.