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

NCT07538024 | Recruiting

• 1 other identifier: 2025-15
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastases to Bone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Local progression-free survival at 3, 6, 12 and 18 months

  At 3, 6, 12 and 18 months from the enrollment

• Adverse events; progression on a new vertebral segment; pain relief and pseudoprogression

  At 3, 6, 12, 18 and 24 months from enrollment

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

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

Experimental arm

EXPERIMENTAL

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

Interventions

Stereotactic Body Radiation Therapy (SBRT) in control arm RADIATION

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.

Control Arm

Stereotactic Body Radiation Therapy (SBRT) in experimental arm RADIATION

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.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• More than 2 adjoining vertebrae involved
• Palliative intent
• or more lesions on the target vertebra
• Contraindications to MRI
• More than 5 metastases

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead

Study Sites (1)

IRCCS Sacro Cuore Don Calabria

Negrar, Verona, 37024, Italy

RECRUITING

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Elvia Malo, Dr.

CONTACT

+39 0456014854; elvia.malo@sacrocuore.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Control arm: volume definition according to Cox contouring guidelines \[doi: 10.1016/j.ijrobp.2012.03.009\] * Experimental arm: volume definition based on the pathological lesion at MRI. The statistical unit will be the individual vertebral metastases.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 20, 2026
• Study Start: November 4, 2025
• Primary Completion (Estimated): May 4, 2029
• Study Completion (Estimated): May 4, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

IT (1)