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.
Performance status ECOG ≤2
Life 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 histology
At least one bone metastasis treatable with SABR or SRS
Sites of disease not eligible for stereotactic radiotherapy
Serious medical comorbidities that preclude RT
Overlap with a previously treated volume of radiotherapy
Dimension greater than 5 cm for extra-cranial lesions.
Parallel
radiosurgery and stereotactic ablative radiotherapy with simultaneous integrated boost, respectively
RadiationTwo protocols of stereotactic ablative radiotherapy, in one vs five fractions ( the later with SIB) are compared
Local recurrence-free surival
evaluation of the impact of stereotactic radiotherapy (one fraction versus fractionated) on local control of disease in terms of local recurrence free survival (LRFS) in patients with oligometastastic disease and at least one bone metastasis.
Acute and late local toxicity
Impact of the two treatments on the local radioinduced toxicity in terms of incidence in skeletal events and acute and late toxicity measured with the Common Terminology Criteria for Adverse Events v5.0 scale
Pain control
Pain control of symptomatic bone lesions measured through the variation of pain diary
Overall survival
Overall-surival
Cancer Specific Survival
Cancer Specific Survival
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