Actively Recruiting
Pilot Randomized Study for Treatment Volume De-Escalation for Spinal Metastases With Stereotactic Body Radiation Therapy
Led by IRCCS Sacro Cuore Don Calabria di Negrar · Updated on 2026-04-20
100
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A single centre, non-profit, randomised, unblinded pilot study on volume definition for spinal stereotactic body radiation therapy treatment. Randomization will be 1:1 between two types of SBRT treatment for spinal metastases. The statistical unit will be the individual vertebral metastasis. Multiple metastases will be randomized and evaluated independently.
CONDITIONS
Official Title
Pilot Randomized Study for Treatment Volume De-Escalation for Spinal Metastases With Stereotactic Body Radiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients affected by spinal metastases eligible for SBRT
- All histologies are allowed
- Oligometastatic disease with a maximum of 5 metastases in any setting
- Metastases treated with ablative intent
- Both symptomatic and asymptomatic vertebral metastases
- Spine Instability Neoplastic Score (SINS) less than 7
- Age greater than 18 years
- Life expectancy greater than 12 months
- Performance status (ECOG) of 0-1
- Vertebral pathological lesion visible on diagnostic MRI
- Single active lesion on the target vertebra
- Multiple lesions on different vertebrae can be treated simultaneously
- Signed informed consent for trial participation and data use
You will not qualify if you...
- More than 2 adjoining vertebrae involved
- Treatment with palliative intent
- Two or more lesions on the target vertebra
- Contraindications to MRI
- More than 5 metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Sacro Cuore Don Calabria
Negrar, Verona, Italy, 37024
Actively Recruiting
Research Team
E
Elvia Malo, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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