SBRT Technique Implementation for Spinal Metastases Irradiation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Oncology Ljubljana
About this trial
Stereotactic body radiotherapy (SBRT) is a highly precise, image-guided radiotherapy technique delivering 1-5 high-dose fractions to spinal metastases. Compared with conventional radiotherapy, SBRT enables delivery of a higher biologically effective dose while maintaining high precision.
The Institute of Oncology Ljubljana initiated spinal SBRT treatments in 2017 and introduced an institutional SBRT spine protocol in 2019. As SBRT is technically demanding, strict adherence to standardized planning and delivery procedures is essential to ensure treatment quality and patient safety.
This clinical program aims to support structured implementation and continuous development of the institutional SBRT spine protocol in routine clinical practice. The study prospectively evaluates treatment-related toxicity and local tumor control following SBRT for spinal metastases in order to monitor treatment safety and effectiveness within the institutional program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Inability to tolerate SBRT positioning or immobilization.
Clinical situations requiring urgent surgical intervention or alternative treatment.
Other medical conditions that prevent safe SBRT delivery.
Trial design
Design model
Single group
Treatments tested in this trial
Stereotactic Body Radiotherapy (SBRT) for Spinal Metastases
Procedure/SurgeryParticipants with spinal tumors or spinal metastases receive image-guided stereotactic body radiotherapy (SBRT) delivered in 1-5 high-dose fractions according to the institutional SBRT spine protocol. The implementation programme includes standardized treatment planning procedures, protocol updates, immobilization techniques, image-guided verification (IGRT), and prospective peer review of target delineation and treatment plans to ensure quality and safety
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: SBRT for Spinal MetastasesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Treatment-Related Adverse Event Grade Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Within 12 Months After Spine SBRT
Maximum treatment-related adverse event grade per patient within 12 months after stereotactic body radiotherapy (SBRT) for spinal metastases, assessed using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 grading scale.
Time frame
From start of SBRT treatment up to 12 months after SBRTSecondary outcomes
1
Incidence of Grade 3 or Higher Treatment-Related Adverse Events Assessed by CTCAE Version 5.0
Percentage of patients experiencing Grade 3 or higher treatment-related adverse events within 12 months after SBRT, assessed using the CTCAE version 5.0 grading scale.
Time frame
From start of SBRT treatment up to 12 months after SBRTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov