Reducing treatment volume for spinal metastases using stereotactic body radiation therapy
A Randomized, Pilot Study on tREatment VOLume De-escalation for SPINal mEtastases SBRT (REVOL-SPINE)
This pilot study will try using MRI-defined tumor volumes instead of standard guideline volumes for SBRT in adults with up to five spinal metastases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Sacro Cuore Don Calabria di Negrar Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Negrar, Verona) |
| Trial ID | NCT07538024 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized (1:1), unblinded pilot compares two SBRT planning approaches for vertebral metastases: standard Cox guideline contouring versus MRI-defined pathological lesion volumes. Each vertebral metastasis is randomized and treated in three or five fractions after CT simulation and MRI coregistration; GTV is defined using MRI (and PET if available) with a 2 mm isotropic PTV margin while avoiding the spinal canal. Follow-up includes MRI at 3 and 6 months and then every 6 months up to two years, with routine visits to record adverse events and pain using the NRS. Outcomes focus on local response, toxicity, and pain changes compared to baseline.
Who should consider this trial
Good fit: Adults (age >18) with up to five metastatic lesions, ECOG 0-1, life expectancy over 12 months, SINS < 7, and a single active lesion per treated vertebra who are candidates for SBRT are eligible.
Not a fit: Patients with more than five metastases, more than two adjacent vertebrae involved, multiple lesions in the same vertebra, contraindications to MRI, or those treated with palliative intent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce radiation exposure to nearby healthy spinal tissues while maintaining local tumor control.
How similar studies have performed: MRI-based target delineation and precise SBRT targeting are established practices, but randomized evidence specifically testing systematic volume de-escalation for spinal metastases is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * More than 2 adjoining vertebrae involved * Palliative intent * 2 or more lesions on the target vertebra * Contraindications to MRI * More than 5 metastases
Where this trial is running
Negrar, Verona
- IRCCS Sacro Cuore Don Calabria — Negrar, Verona, Italy (Recruiting)
Study contacts
- Study coordinator: Elvia Malo, Dr.
- Email: elvia.malo@sacrocuore.it
- Phone: +39 0456014854
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.