Bone Metastases, Spinal Metastases, Spinal Tumors
Conditions
Brief summary
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.
Detailed description
This clinical program supports the structured implementation and continuous development of stereotactic body radiotherapy (SBRT) for spinal metastases at the Institute of Oncology Ljubljana. The program includes prospective peer review of target delineation and treatment plans, structured educational activities for involved staff, and continuous quality assurance procedures to maintain protocol adherence and treatment standardization. Retrospective review of previously delivered SBRT plans may be performed to evaluate consistency with institutional protocol standards. All enrolled patients receive SBRT according to the institutional SBRT spine protocol. Clinical evaluation focuses on treatment-related toxicity assessed using standardized criteria and on radiological local tumor control during follow-up. Toxicity is evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), and local control is assessed using routine radiological imaging. All collected data are anonymized. Participation in the study does not involve additional interventions, procedures, or risks beyond standard SBRT treatment and routine clinical follow-up.
Interventions
PROCEDUREStereotactic Body Radiotherapy (SBRT) for Spinal Metastases
Participants 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
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants with spinal tumors or spinal metastases receive SBRT irradiation according to the institutional SBRT spine protocol and implementation programme, including standardized planning workflow and peer review.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Treatment-Related Adverse Event Grade Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Within 12 Months After Spine SBRT | From start of SBRT treatment up to 12 months after 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade 3 or Higher Treatment-Related Adverse Events Assessed by CTCAE Version 5.0 | From start of SBRT treatment up to 12 months after SBRT | 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. |
Countries
Slovenia
Contacts
CONTACTJasna But Hadžić, MD
CONTACTKlavdija Korošec
Outcome results
None listed