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

Recruiting now · Not applicable

Conditions studied: Oligometastatic Disease

In brief

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.

Key facts

Study ID

NCT05679427

Run by

IRCCS San Raffaele

People needed

307

Starts

2022-11-07

Expected to finish

2027-12-07

Last updated by the study team

2025-06-11

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 metastases
• Clinical or radiological evidence of spinal cord compression or epidural tumor within 2mm of the spinal cord
• Radiological evidence of vertebral body fracture or involvement of more than 40% of the vertebral body
• Radiological evidence of cortical involvement in long bones
• Pregnant or breastfeeding women

Where it is running

• San Raffaele Scientific Institute — Milan, MI, Italy (enrolling)

Full record on ClinicalTrials.gov

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