Metastases to BoneREVOL-SPINENCT07538024
Pilot Randomized Study for Treatment Volume De-Escalation for Spinal Metastases With Stereotactic Body Radiation Therapy
A study testing Stereotactic Body Radiation Therapy (SBRT) in experimental arm in people with Metastases to Bone, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastases to Bone
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT) in experimental arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 4 Nov 2025to 4 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
Show all 13Show fewer
- 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
Who cannot join
- More than 2 adjoining vertebrae involved
- Palliative intent
- 2 or more lesions on the target vertebra
- Contraindications to MRI
- More than 5 metastases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria
Negrar, Verona, 37024
Edoardo Pastorello, Dr., +39 0456014800, edoardo.pastorello@sacrocuore.it
About this study
Official title: A Randomized, Pilot Study on tREatment VOLume De-escalation for SPINal mEtastases SBRT (REVOL-SPINE)
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.
Read the detailed description
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:
- Control arm: volume definition according to Cox contouring guidelines
- Experimental arm: volume definition based on the pathological lesion at Magnetic Resonance Imaging (MRI).
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.
- Conditions
- Metastases to Bone
- Being tested
- Stereotactic Body Radiation Therapy (SBRT) in control arm, Stereotactic Body Radiation Therapy (SBRT) in experimental arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT) in control armRadiation
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 (SBRT) in experimental armRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | 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] Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) in control arm |
| Experimental arm | Experimental | volume definition of SBRT based on the pathological lesion at MRI delivered in three or five fractions Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) in experimental arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 2 years from enrollment
Secondary outcomes (2)
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
Measured: 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
Measured: At 3, 6, 12, 18 and 24 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start4 Nov 2025
- Primary completion4 May 2029 (estimated)
- Study completion4 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastases to BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- * Control arm: volume definition according to Cox contouring guidelines \[doi: 10.1016/j.ijrobp.2012.03.009\] * Experimental arm: volume definition based on the pathological lesion at MRI. The statistical unit will be the individual vertebral metastases.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538024
- Sponsor's protocol ID
- 2025-15
- Acronym
- REVOL-SPINE
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Pilot Study on tREatment VOLume De-escalation for SPINal mEtastases SBRT (REVOL-SPINE)
- ClinicalTrials.gov ID
- NCT07538024
- Acronym / sponsor ID
- REVOL-SPINE / 2025-15
- Conditions
- Metastases to Bone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 4 May 2029 (estimated)
- Study completion
- 4 May 2029 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Control arm: volume definition according to Cox contouring guidelines
- Experimental arm: volume definition based on the pathological lesion at Magnetic Resonance Imaging (MRI).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Control arm: volume definition according to Cox contouring guidelines [doi: 10.1016/j.ijrobp.2012.03.009] * Experimental arm: volume definition based on the pathological lesion at MRI. The statistical unit will be the individual vertebral metastases.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Radiation: Stereotactic Body Radiation Therapy (SBRT) in control armvolume definition of SBRT according to Cox contouring guidelines [Cox BW, International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery] |
| Experimental arm | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT) in experimental armvolume definition of SBRT based on the pathological lesion at MRI delivered in three or five fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- More than 2 adjoining vertebrae involved
- Palliative intent
- 2 or more lesions on the target vertebra
- Contraindications to MRI
- More than 5 metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) in control armStereotactic 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. | Radiation | Control Arm |
| Stereotactic Body Radiation Therapy (SBRT) in experimental armStereotactic 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. | Radiation | Experimental arm |
Primary outcome
2-years local progression-free survival
Time frame: At 2 years from enrollment
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.
2 secondary outcomes
Local progression-free survival at 3, 6, 12 and 18 months
Time frame: At 3, 6, 12 and 18 months from the enrollment
Adverse events; progression on a new vertebral segment; pain relief and pseudoprogression
Time frame: At 3, 6, 12, 18 and 24 months from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy (SBRT) in experimental arm in people with Metastases to Bone, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elvia Malo, Dr. (+39 0456014854, elvia.malo@sacrocuore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-years local progression-free survival (time frame: At 2 years from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.