Ablative Radiosurgery vs Stereotactic RT in 5 Fractions With SIB for Oligometastatic Bone Lesions
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 * Each 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 radiotherapy * Serious medical comorbidities that preclude RT * Overlap with a previously treated volume of radiotherapy * Dimension greater than 5 cm for extra-cranial lesions. * Size greater than 3 cm for brain lesions * More than 1 brain metas