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NCT Number: NCT07429422

SBRT Technique Implementation for 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.

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Key information

Conditions

Spinal Metastases Bone Metastases Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Spinal Cord Diseases Spinal Cord Neoplasms Spinal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Oncology, Ljubljana, Slovenia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

    Time frame: 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 outcomes

  1. Incidence of Grade 3 or Higher Treatment-Related Adverse Events Assessed by CTCAE Version 5.0

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jasna But Hadžić, MD

CONTACT

[email protected]

+38615879648

Klavdija Korošec

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

Program SBRT Technique Implementation in Spinal Metastases Irradiation

Important dates

Study start
2021
Primary completion
2022
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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