SBRT Technique Implementation for Spinal Metastases Irradiation

NCT07429422 | Recruiting

• 1 other identifier: OI-SBRT-SPINAL-BUT-2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Metastases; Spinal Tumors; Bone Metastases

Outcome Measures

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.

  From start of SBRT treatment up to 12 months after SBRT

Secondary Outcomes (1)

• 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

Study Arms (1)

SBRT for Spinal Metastases

EXPERIMENTAL

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

Interventions

Stereotactic Body Radiotherapy (SBRT) for Spinal Metastases PROCEDURE

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

SBRT for Spinal Metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• Inability to tolerate SBRT positioning or immobilization.
• Clinical situations requiring urgent surgical intervention or alternative treatment.
• Other medical conditions that prevent safe SBRT delivery.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (2)

Institute of Oncology

Ljubljana, 1000, Slovenia

RECRUITING

Institute of Oncology Ljubljana

Ljubljana, SI-1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Spinal Cord Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jasna But Hadžić, MD

CONTACT

+38615879648; jbut@onko-i.si

Klavdija Korošec

CONTACT

kkorosec@onko-i.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 24, 2026
• Study Start: November 1, 2021
• Primary Completion: December 31, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2)