Ablative Radiosurgery vs Stereotactic RT in 5 Fractions With SIB for Oligometastatic Bone Lesions

This is a randomised prospective monoinstitutional study comparing radiosurgery at a total dose up to 24 Gy to five fraction stereotactic radiotherapy with simultaneous integrated boost (SIB) up to 50 Gy for the treatment of bone metastases in oligometastatic cancer treated with radical intent. At the end of the first 12 months from the start of the study an interim analysis will be performed taking into account all major endpoints for an initial evaluation of the study , with only an observational purpose, without subsequent protocol changes.

Inclusion Criteria:Performance status ECOG ≤2Life expectancy > 6 months according to Mizumoto criteria*Oligometastatic disease (Total number of metastases from 1 to 5: both synchronous and metachronous with maximum involvement of three organs in total - lymph nodes, bones, lungs, liver, adrenal gland, brain- with known histologyAt least one bone metastasis treatable with SABR or SRSEach secondary localization (synchronous, metachronous or oligoprogressive) must be treated with radical intent.Patients may have received other anticancer treatments (surgery for initial site of disease or other metastases, chemotherapy, radiotherapy for other metastatic sites)Exclusion Criteria:Sites of disease not eligible for stereotactic radiotherapySerious medical comorbidities that preclude RTOverlap with a previously treated volume of radiotherapyDimension greater than 5 cm for extra-cranial lesions.Size greater than 3 cm for brain lesionsMore than 1 brain metastasesClinical or radiological evidence of spinal cord compression or epidural tumor within 2mm of the spinal cordRadiological evidence of vertebral body fracture or involvement of more than 40% of the vertebral bodyRadiological evidence of cortical involvement in long bonesPregnant or breastfeeding women