Pilot Randomized Study for Treatment Volume De-Escalation for Spinal Metastases With Stereotactic Body Radiation Therapy
A Randomized, Pilot Study on tREatment VOLume De-escalation for SPINal mEtastases SBRT (REVOL-SPINE)
IRCCS Sacro Cuore Don Calabria di Negrar
100 participants
Nov 4, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria13
- Patients affected by spinal metastases eligible for SBRT
- All histologies are allowed
- Oligometastatic disease (maximum 5 metastases) in every setting (oligopersistent, oligorecurrent and oligoprogressive, according to ESTRO consensus)
- Metastases treated with ablative intent
- Both symptomatic and asymptomatic vertebral metastases
- Spine Instability Neoplastic Score (SINS) score < 7 \[18\]
- Age > 18 years
- Life expectancy > 12 months
- PS ECOG 0-1
- Vertebral pathological lesion on the diagnostic MRI
- Single active lesion on the target vertebra
- More lesions in different vertebrae can be simultaneously treated
- Informed consent to trial participation and personal data treatment
Exclusion Criteria5
- More than 2 adjoining vertebrae involved
- Palliative intent
- or more lesions on the target vertebra
- Contraindications to MRI
- More than 5 metastases
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Interventions
Stereotactic Body Radiation Therapy performed in vertebral metastases with volume definition according to Cox contouring guidelines. The treatment will be delivered at the participating center in either three or five fractions. The planned follow-up consists of routine visits and exams as per common clinical practice, according to primary histology (including an MRI to evaluate response of the vertebral lesion treated) at 3 months, 6 months, and subsequently every 6 months until the 2-year follow-up period. The definition of the CTV in the control arm will include the vertebral region according to Cox contouring guidelines and the PTV will be obtained by adding an isotropic margin of 2 mm from the CTV, avoiding the spinal canal.
Stereotactic Body Radiation Therapy performed in vertebral metastases with volume definition based on the pathological lesion at MRI. The treatment will be delivered at the participating center in either three or five fractions. The planned follow-up consists of routine visits and exams as per common clinical practice, according to primary histology (including an MRI to evaluate response of the vertebral lesion treated) at 3 months, 6 months, and subsequently every 6 months until the 2-year follow-up period. Gross tumor volume (GTV) in the experimental arm will include the part of pathological uptake on MRI, after rigid co-registration with the simulation CT: the treatment volume will be delineated based on the diagnostic magnetic resonance imaging (MRI) coregistered with the planning computed tomography (CT) scan. The MRI protocol will include contrast-enhanced T1, T2-weighted, and diffusion-weighted imaging (DWI) sequences.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07538024