Clinical trial · Interventional
SBRT Technique Implementation for Spinal Metastases Irradiation
Program SBRT Technique Implementation in Spinal Metastases Irradiation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | — | UNRESOLVED | — |
| Spinal Metastases | — | UNRESOLVED | — |
| Spinal Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) for Spinal Metastases | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT for Spinal Metastases
- description
- Participants with spinal tumors or spinal metastases receive stereotactic body radiotherapy (SBRT) according to the institutional SBRT spine protocol. The implementation programme includes standardized workflow, regular SBRT educational workshops, protocol updates, image-guided radiotherapy verification, and prospective peer review of target delineation and treatment plans. Treatment outcomes including toxicity and local control are monitored prospectively
- interventionNames
- Procedure: Stereotactic Body Radiotherapy (SBRT) for Spinal Metastases
Primary outcomes (1)
- measure
- Maximum Treatment-Related Adverse Event Grade Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Within 12 Months After Spine SBRT
- timeFrame
- From start of SBRT treatment up to 12 months after SBRT
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available