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Compares treatment options for Oligometastatic Disease
Official title Ablative Radiosurgery vs Stereotactic RT in 5 Fractions With SIB for Oligometastatic Bone Lesions
ClinicalTrials.gov ID: NCT05679427
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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...
- At least one bone metastasis treatable with SABR or SRS
- Each secondary localization (synchronous, metachronous or oligoprogressive) must be treated with radical intent.
You likely can't join 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
See the full eligibility 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...
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Milan, MI, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, MI, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.