SBRT Technique Implementation for Spinal Metastases Irradiation

Program SBRT Technique Implementation in Spinal Metastases Irradiation

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Metastases; Spinal Metastases; Spinal Tumors
• Intervention / Treatment: Procedure: Stereotactic Body Radiotherapy (SBRT) for Spinal Metastases

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klavdija Korošec; Email: kkorosec@onko-i.si
• Study Contact Backup: Name: Jasna But Hadžić, MD; Phone Number: +38615879648; Email: jbut@onko-i.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • Institute of Oncology
    • Contact: Jasna But-Hadzic, MD; Phone Number: +38615879503; Email: jbut@onko-i.si
    • Contact: Vaneja Velenik, MD,PhD, asist. prof.; Phone Number: +38615879661; Email: vvelenik@onko-i.si
  • Ljubljana, Slovenia, SI-1000
    • Recruiting
    • Institute of Oncology Ljubljana
    • Contact: Klavdija Korošec; Phone Number: +386 1 5438 391; Email: kkorosec@onko-i.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SBRT for Spinal Metastases; 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

Procedure: Stereotactic 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From start of SBRT treatment up to 12 months after SBRT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From start of SBRT treatment up to 12 months after SBRT

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Spinal Cord Diseases; Spinal Cord Neoplasms; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery
• Other Study ID Numbers: OI-SBRT-SPINAL-BUT-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No