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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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

Primary outcome measure(s)

• 2-years local progression-free survival — At 2 years from enrollment
  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.

Trial sites (1)

More IRCCS Sacro Cuore Don Calabria di Negrar trials in Italy