Clinical Trials in Italy / NCT05679427
Recruiting Not applicable

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

NCT05679427 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2022-11-07
Last updated
2025-06-11

Condition(s) studied

Oligometastatic Disease

Investigational drug(s) / intervention(s)

radiosurgery and stereotactic ablative radiotherapy with simultaneous integrated boost, respectively

radiosurgery and stereotactic ablative radiotherapy with simultaneous integrated boost, respectively: Two protocols of stereotactic ablative radiotherapy, in one vs five fractions ( the later with SIB) are compared

Study 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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
San Raffaele Scientific Institute Milan MI Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05679427 on ClinicalTrials.gov ↗ ← All trials in Italy