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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Sacro Cuore Don Calabria di Negrar

About this trial

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 criteria

Qualifiers

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

Disqualifiers

More than 2 adjoining vertebrae involved

Palliative intent

2 or more lesions on the target vertebra

Contraindications to MRI

Trial design

Treatments tested in this trial

  • Stereotactic Body Radiation Therapy (SBRT) in control arm
  • Stereotactic Body Radiation Therapy (SBRT) in experimental arm

Treatment groups

100 Participants
are divided into 2 treatment groups