Clinical Research Directory

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 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.