Actively Recruiting
Ablative Radiosurgery vs Stereotactic RT in 5 Fractions With SIB for Oligometastatic Bone Lesions
Led by IRCCS San Raffaele · Updated on 2025-06-11
307
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ablative Radiosurgery vs Stereotactic RT in 5 Fractions With SIB for Oligometastatic Bone Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Performance status ECOG 642
- Life expectancy greater than 6 months according to Mizumoto criteria
- Oligometastatic disease with 1 to 5 metastases, including synchronous or metachronous involvement of up to three organs (lymph nodes, bones, lungs, liver, adrenal gland, brain) with known histology
- At least one bone metastasis suitable for stereotactic ablative radiotherapy or radiosurgery
- Each metastatic site must be treated with curative intent
- Patients may have received prior anticancer treatments including surgery, chemotherapy, or radiotherapy for other metastatic sites
You will not qualify if you...
- Disease sites not suitable for stereotactic radiotherapy
- Serious medical conditions that prevent radiotherapy
- Overlapping area with previously treated radiotherapy volume
- Lesion size greater than 5 cm for extracranial sites
- Lesion size greater than 3 cm for brain metastases
- More than one brain metastasis
- Clinical or imaging evidence of spinal cord compression or tumor within 2 mm of spinal cord
- Imaging evidence of vertebral body fracture or involvement of more than 40% of vertebral body
- Imaging evidence of cortical involvement in long bones
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
San Raffaele Scientific Institute
Milan, MI, Italy, 20132
Actively Recruiting
Research Team
N
Nadia G Di Muzio, Prof.
CONTACT
A
Andrei Fodor, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here