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Recruiting NCT07429422

SBRT Technique Implementation for Spinal Metastases Irradiation

No phase Interventional Spinal Metastases Spinal Tumors Bone Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stereotactic Body Radiotherapy (SBRT) for Spinal Metastases.
Who it may be relevant to
Registry conditions: Spinal Metastases, Spinal Tumors, Bone Metastases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Program SBRT Technique Implementation in Spinal Metastases Irradiation

Overview

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

  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Slovenia · 2 centers
  • Institute of Oncology — Ljubljana
  • Institute of Oncology Ljubljana — Ljubljana

Identifiers

NCT: NCT07429422 · OI-SBRT-SPINAL-BUT-2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗