Actively Recruiting
Program SBRT Technique Implementation in Spinal Metastases Irradiation
Led by Institute of Oncology Ljubljana · Updated on 2026-02-24
100
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating stereotactic body radiotherapy (SBRT), a precise, image-guided radiotherapy technique that delivers high-dose radiation in 1 to 5 sessions to treat spinal metastases and spinal tumors. This clinical program at the Institute of Oncology Ljubljana aims to support the structured use and ongoing development of the institutional SBRT spine protocol, focusing on treatment safety and tumor control. The study started after implementing SBRT in 2017 and introduced a standardized protocol in 2019 to maintain treatment quality and patient safety. Patients with spinal tumors or metastases receive SBRT following the institutional spine protocol, which includes standardized planning, immobilization, image-guided radiotherapy verification, and peer review of treatment plans. The program also involves regular educational workshops and quality assurance to ensure adherence to the protocol. Treatments are carefully planned and delivered with high precision to monitor outcomes continuously. Participants undergo routine clinical evaluations to assess treatment-related side effects using standardized criteria and to monitor local tumor control through regular radiological imaging. Data collected during the study are anonymized and involve no additional procedures beyond standard SBRT treatment and follow-up. The primary outcome is the maximum treatment-related adverse event grade within 12 months of SBRT, with ongoing monitoring of significant side effects and tumor control during this period.
CONDITIONS
Brief Title
SBRT Technique Implementation for Spinal Metastases Irradiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Inability to tolerate SBRT positioning or immobilization.
- Clinical situations requiring urgent surgical intervention or alternative treatment.
- Other medical conditions that prevent safe SBRT delivery.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Treatment duration varies depending on number of fractions delivered
Participants receive stereotactic body radiotherapy (SBRT) for spinal metastases delivered in 1 to 5 high-dose fractions according to the institutional SBRT spine protocol, including standardized treatment planning, immobilization, image-guided verification, and peer review to ensure quality and safety.
1 to 5 treatment visits (in-person)
Duration - Up to 12 months after treatment
Participants are monitored for treatment-related toxicity and local tumor control using routine clinical evaluations and radiological imaging for up to 12 months after SBRT treatment.
Multiple follow-up visits scheduled as part of routine clinical care
Trial Site Locations
Total: 2 locations
1
Institute of Oncology
Ljubljana, Slovenia, 1000
Actively Recruiting
2
Institute of Oncology Ljubljana
Ljubljana, Slovenia, SI-1000
Actively Recruiting
Research Team
J
Jasna But Hadžić, MD
K
Klavdija Korošec
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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