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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorIRCCS San Raffaele

About this trial

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

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • radiosurgery and stereotactic ablative radiotherapy with simultaneous integrated boost, respectively

Treatment groups

307 Participants
are divided into 2 treatment groups

Sponsors and collaborators