Pilot Randomized Study for Treatment Volume De-Escalation for Spinal Metastases With Stereotactic Body Radiation Therapy (REVOL-SPINE)

A Randomized, Pilot Study on tREatment VOLume De-escalation for SPINal mEtastases SBRT (REVOL-SPINE)

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.

Study Overview

• Status: Recruiting
• Conditions: Metastases to Bone
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy (SBRT) in control arm; Radiation: Stereotactic Body Radiation Therapy (SBRT) in experimental arm

Detailed Description

Patients with spinal oligometastases who will be evaluated for SBRT will have to sign informed consent before any study-related procedure. Afterwards, a simulation computed tomography (CT) will be performed, and the metastases will be randomized to:

• Control arm: volume definition according to Cox contouring guidelines
• Experimental arm: volume definition based on the pathological lesion at Magnetic Resonance Imaging (MRI).

The treatment will be delivered at the 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. During these visits, physicians will assess the adverse events and NRS (a unidimensional measure of pain intensity in adults, from 0 to 10, and the result will be compared to the baseline).

The gross tumor volume (GTV) will be defined by MRI and PET uptake, if available, and the simulation CT. The treatment volume will be delineated based on MRI coregistered with the planning CT. The MRI protocol will include T1, T2-weighted, and diffusion-weighted imaging (DWI) sequences. The Planning Target Volume (PTV) will be obtained by adding an isotropic margin of 2 mm from the GTV, avoiding the spinal canal.

The clinical target volume (CTV) will be defined by the vertebral region according to the Cox contouring guidelines, and the PTV will be obtained by adding an isotropic margin of 2 mm from the CTV, avoiding the spinal canal.

Radiotherapy dose:

According to the current guidelines, available fractionations are 30 Gy in 3 fractions or 35 Gy in 5 fractions.

Planning:

The plan evaluation ensures at least 95% of the prescribed dose to 95% of the PTV without exceeding 120% of the prescribed dose. A partial PTV uncovering will be accepted if necessary to preserve mandatory constraints to OARs, considering a minor deviation if 95% of the PTV receives 85% or more of the prescribed dose, and a major deviation if 95% of the PTV receives less than 85% of the prescribed dose. Any deviation will be recorded but will not impact the patient's participation in the study.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elvia Malo, Dr.; Phone Number: +39 0456014854; Email: elvia.malo@sacrocuore.it

Study Locations

• Italy
  • Verona
    • Negrar, Verona, Italy, 37024
      • Recruiting
      • IRCCS Sacro Cuore Don Calabria
      • Contact: Edoardo Pastorello, Dr.; Phone Number: +39 0456014800; Email: edoardo.pastorello@sacrocuore.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm; volume definition of SBRT according to Cox contouring guidelines [Cox BW, International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery]	Radiation: Stereotactic Body Radiation Therapy (SBRT) in control arm; 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.
Experimental: Experimental arm; volume definition of SBRT based on the pathological lesion at MRI delivered in three or five fractions	Radiation: Stereotactic Body Radiation Therapy (SBRT) in experimental arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-years local progression-free survival	Evaluation of the 2-years local progression-free survival (LPFS) of a different volume of SBRT for spinal treatment, targeted to the pathological lesion, evaluating the response after irradiation.	At 2 years from enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local progression-free survival at 3, 6, 12 and 18 months	Evaluation of local progression-free survival at 3, 6, 12 and 18 months of a different volume of SBRT for spinal treatment, targeted to the pathological lesion, evaluating the response after irradiation	At 3, 6, 12 and 18 months from the enrollment
Adverse events; progression on a new vertebral segment; pain relief and pseudoprogression	Detection of: adverse events related to the radiation treatment; progression on a new vertebral segment on the same vertebra, diagnosed on MRI; pain relief (> 4 before the SBRT); rate of pseudoprogression, defined as an increase of the lesion at MRI, not confirmed by subsequent examinations	At 3, 6, 12, 18 and 24 months from enrollment

Collaborators and Investigators

• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): May 4, 2029
• Study Completion (Estimated): May 4, 2029

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery
• Other Study ID Numbers: 2025-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No