An interventional study of Stereotactic Body Radiation Therapy (SBRT) in control arm and Stereotactic Body Radiation Therapy (SBRT) in experimental arm in Metastases to Bone, sponsored by IRCCS Sacro Cuore Don Calabria di Negrar. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by IRCCS Sacro Cuore Don Calabria di Negrar · Not applicable, Interventional, and Treatment
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.
Patients with spinal oligometastases who will be evaluated for SBRT will have to sign informed consent before any study-related procedure. Afterwards, a simulation computed tomography (CT) will be performed, and the metastases will be randomized to:
The treatment will be delivered at the center in either three or five fractions.
The planned follow-up consists of routine visits and exams, as per common clinical practice, according to primary histology (including an MRI to evaluate response of the vertebral lesion treated) at 3 months, 6 months, and subsequently every 6 months until the 2-year follow-up period. During these visits, physicians will assess the adverse events and NRS (a unidimensional measure of pain intensity in adults, from 0 to 10, and the result will be compared to the baseline).
The gross tumor volume (GTV) will be defined by MRI and PET uptake, if available, and the simulation CT. The treatment volume will be delineated based on MRI coregistered with the planning CT. The MRI protocol will include T1, T2-weighted, and diffusion-weighted imaging (DWI) sequences. The Planning Target Volume (PTV) will be obtained by adding an isotropic margin of 2 mm from the GTV, avoiding the spinal canal.
The clinical target volume (CTV) will be defined by the vertebral region according to the Cox contouring guidelines, and the PTV will be obtained by adding an isotropic margin of 2 mm from the CTV, avoiding the spinal canal.
Radiotherapy dose:
According to the current guidelines, available fractionations are 30 Gy in 3 fractions or 35 Gy in 5 fractions.
Planning:
The plan evaluation ensures at least 95% of the prescribed dose to 95% of the PTV without exceeding 120% of the prescribed dose. A partial PTV uncovering will be accepted if necessary to preserve mandatory constraints to OARs, considering a minor deviation if 95% of the PTV receives 85% or more of the prescribed dose, and a major deviation if 95% of the PTV receives less than 85% of the prescribed dose. Any deviation will be recorded but will not impact the patient's participation in the study.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →IRCCS Sacro Cuore Don Calabria di Negrar is the lead sponsor of 38 studies on the registry; 22 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
volume definition of SBRT according to Cox contouring guidelines \[Cox BW, International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery\]
Radiation: Stereotactic Body Radiation Therapy (SBRT) in control arm
volume definition of SBRT based on the pathological lesion at MRI delivered in three or five fractions
Radiation: Stereotactic Body Radiation Therapy (SBRT) in experimental arm
Stereotactic Body Radiation Therapy performed in vertebral metastases with volume definition according to Cox contouring guidelines. The treatment will be delivered at the participating center in either three or five fractions. The planned follow-up consists of routine visits and exams as per common clinical practice, according to primary histology (including an MRI to evaluate response of the vertebral lesion treated) at 3 months, 6 months, and subsequently every 6 months until the 2-year follow-up period. The definition of the CTV in the control arm will include the vertebral region according to Cox contouring guidelines and the PTV will be obtained by adding an isotropic margin of 2 mm from the CTV, avoiding the spinal canal.
Stereotactic Body Radiation Therapy performed in vertebral metastases with volume definition based on the pathological lesion at MRI. The treatment will be delivered at the participating center in either three or five fractions. The planned follow-up consists of routine visits and exams as per common clinical practice, according to primary histology (including an MRI to evaluate response of the vertebral lesion treated) at 3 months, 6 months, and subsequently every 6 months until the 2-year follow-up period. Gross tumor volume (GTV) in the experimental arm will include the part of pathological uptake on MRI, after rigid co-registration with the simulation CT: the treatment volume will be delineated based on the diagnostic magnetic resonance imaging (MRI) coregistered with the planning computed tomography (CT) scan. The MRI protocol will include contrast-enhanced T1, T2-weighted, and diffusion-weighted imaging (DWI) sequences.
2-years local progression-free survival
Evaluation of the 2-years local progression-free survival (LPFS) of a different volume of SBRT for spinal treatment, targeted to the pathological lesion, evaluating the response after irradiation.
Time frame: At 2 years from enrollment
Local progression-free survival at 3, 6, 12 and 18 months
Evaluation of local progression-free survival at 3, 6, 12 and 18 months of a different volume of SBRT for spinal treatment, targeted to the pathological lesion, evaluating the response after irradiation
Time frame: At 3, 6, 12 and 18 months from the enrollment
Adverse events; progression on a new vertebral segment; pain relief and pseudoprogression
Detection of: * adverse events related to the radiation treatment * progression on a new vertebral segment on the same vertebra, diagnosed on MRI * pain relief (\> 4 before the SBRT) * rate of pseudoprogression, defined as an increase of the lesion at MRI, not confirmed by subsequent examinations
Time frame: At 3, 6, 12, 18 and 24 months from enrollment
Plan to share: Undecided
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IRCCS Sacro Cuore Don Calabria di Negrar