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New treatment option for Metastases to Bone
Official title Pilot Randomized Study for Treatment Volume De-Escalation for Spinal Metastases With Stereotactic Body Radiation Therapy
ClinicalTrials.gov ID: NCT07538024
What this study is testing
- What it's testing
- A single centre, non-profit, randomised, unblinded pilot study on volume definition for spinal stereotactic body radiation therapy treatment. Randomization will be 1:1 between two types of SBRT treatment for spinal metastases.
- 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 and older
You may be able to join if
- Patients affected by spinal metastases eligible for SBRT
- All histologies are allowed
- Oligometastatic disease (maximum 5 metastases) in every setting (oligopersistent, oligorecurrent and oligoprogressive, according to ESTRO consensus)
- Metastases treated with ablative intent
- Both symptomatic and asymptomatic vertebral metastases
You likely can't join if
- More than 2 adjoining vertebrae involved
- Palliative intent
- 2 or more lesions on the target vertebra
- Contraindications to MRI
- More than 5 metastases
See the full eligibility criteria
- Patients affected by spinal metastases eligible for SBRT
- All histologies are allowed
- Oligometastatic disease (maximum 5 metastases) in every setting (oligopersistent, oligorecurrent and oligoprogressive, according to ESTRO consensus)
- Metastases treated with ablative intent
- Both symptomatic and asymptomatic vertebral metastases
- Spine Instability Neoplastic Score (SINS) score \< 7 [18]
- Age \> 18 years
- Life expectancy \> 12 months
- PS ECOG 0-1
- Vertebral pathological lesion on the diagnostic MRI
- Single active lesion on the target vertebra
- More lesions in different vertebrae can be simultaneously treated
- Informed consent to trial participation and personal data treatment
- More than 2 adjoining vertebrae involved
- Palliative intent
- 2 or more lesions on the target vertebra
- Contraindications to MRI
- More than 5 metastases
The study team makes the final eligibility decision.
Where it's taking place
- Negrar, Verona, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Negrar, Verona, 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.