Pilot Randomized Study for Treatment Volume De-Escalation for Spinal Metastases With Stereotactic… (NCT07538024) | Clinical Trial Compass
RecruitingNot Applicable
Pilot Randomized Study for Treatment Volume De-Escalation for Spinal Metastases With Stereotactic Body Radiation Therapy
Italy100 participantsStarted 2025-11-04
Plain-language summary
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. The statistical unit will be the individual vertebral metastasis. Multiple metastases will be randomized and evaluated independently.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
Exclusion Criteria:
* More than 2 adjoining vertebrae involved
* Palliative intent
* 2 or more lesions on the target vertebra
* Contraindications to MRI
* More than 5 metastases
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.