Focused high-dose SBRT for spinal tumors
Program SBRT Technique Implementation in Spinal Metastases Irradiation
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Locations | 2 sites (Ljubljana and 1 other locations) |
| Trial ID | NCT07429422 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ljubljana and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.