Spinal MetastasesNCT07429422
SBRT Technique Implementation for Spinal Metastases Irradiation
A study testing Stereotactic Body Radiotherapy (SBRT) for Spinal Metastases in people with Spinal Metastases and Spinal Tumors, run by Institute of Oncology Ljubljana at 2 sites in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases, Spinal Tumors, Bone Metastases
- What is being tested?
- Stereotactic Body Radiotherapy (SBRT) for Spinal Metastases
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSlovenia
- Study dates
- 1 Nov 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to tolerate SBRT positioning or immobilization.
- Clinical situations requiring urgent surgical intervention or alternative treatment.
- Other medical conditions that prevent safe SBRT delivery.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Klavdija Korošec contact
Slovenia2 sites, 2 recruiting
- Recruiting
Institute of Oncology
Ljubljana, 1000
Jasna But-Hadzic, MD, +38615879503, jbut@onko-i.si
Vaneja Velenik, MD,PhD, asist. prof., +38615879661, vvelenik@onko-i.si
- Recruiting
Institute of Oncology Ljubljana
Ljubljana, SI-1000
Klavdija Korošec, +386 1 5438 391, kkorosec@onko-i.si
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Metastases, Spinal Tumors, Bone Metastases
- Being tested
- Stereotactic Body Radiotherapy (SBRT) for Spinal Metastases
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiotherapy (SBRT) for Spinal MetastasesProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Stereotactic Body Radiotherapy (SBRT) for Spinal Metastases |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From start of SBRT treatment up to 12 months after SBRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Nov 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429422
- Sponsor's protocol ID
- OI-SBRT-SPINAL-BUT-2022
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program SBRT Technique Implementation in Spinal Metastases Irradiation
- ClinicalTrials.gov ID
- NCT07429422
- Acronym / sponsor ID
- OI-SBRT-SPINAL-BUT-2022
- Conditions
- Spinal Metastases, Spinal Tumors, Bone Metastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| SBRT for Spinal Metastases | Experimental | Procedure: Stereotactic Body Radiotherapy (SBRT) for Spinal MetastasesParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Inability to tolerate SBRT positioning or immobilization.
- Clinical situations requiring urgent surgical intervention or alternative treatment.
- Other medical conditions that prevent safe SBRT delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) for Spinal MetastasesParticipants 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 | Procedure or surgery | SBRT for Spinal Metastases |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Klavdija Korošec contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiotherapy (SBRT) for Spinal Metastases in people with Spinal Metastases and Spinal Tumors, run by Institute of Oncology Ljubljana at 2 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasna But Hadžić, MD (+38615879648, jbut@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.