Vertebral MetastasesNCT02616887
Study of Image-Guided SBRT for Vertebral Metastases
An observational study of Vertebral Metastases, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Based on the known efficacy of ablative single dose SBRT and VMAT technique in various solid tumors, investigators have designed this study to assess feasibility of SBRT in selected patients with spine metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Metastases
- What is being tested?
- Single dose SBRT and VMAT technique
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 5 Nov 2015to 8 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with spine metastases
Who may be able to join
- Age ≥ 18years.
- WHO performance status ≤ 2 (ECOG - KPS).
- Histologically-proven of primary cancer disease.
- Metastatic disease in the spine, from C1 to Sacrum. A maximum number of 5 sites. Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies.
- Epidural compression is eligible when there is at least 3 mm gap between the spinal cord and the edge of the epidural lesion, unless patient underwent decompression surgery.
- A paraspinal mass ≤ 5 cm.
Show all 9Show fewer
- Minimal residual tumor after surgery
- Metastases in other district of the body are allowed.
- Informed consent.
Who cannot join
- > 50% loss of vertebral body height.
- Prior radiation to the interested spine.
- Patients for whom an MRI of the spine is medically contraindicated.
- Patients allergic to contrast used in MRIs or CT scans or who cannot be premedicated for the use of contrast.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Image-Guided Single Fraction SBRT With VMAT-FFF Technique for Vertebral Metastases
Based on the known efficacy of ablative single dose SBRT and VMAT technique in various solid tumors, investigators have designed this study to assess feasibility of SBRT in selected patients with spine metastases.
Read the detailed description
This is a prospective, phase 2 study. The main objectives are to assess acute and late side effects of single fraction SBRT for selected patients with vertebral metastases and to study the local control of disease in treated sites.
The schedule will be 1 fraction of 18 Gy delivered in one day with Volumetric Modulated Arc Therapy (VMAT) and Flattening filter-free (FFF) beams.
- Conditions
- Vertebral Metastases
- Being tested
- Single dose SBRT and VMAT technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose SBRT and VMAT techniqueRadiation
One fraction of 18 Gy delivered in one day with VMAT and Flattening filter-free (FFF) beams.
| Study group | Role | What they receive |
|---|---|---|
| Vertebral metastases | Selected patients with spine metastases are treated with ablative single dose SBRT and VMAT technique in various solid tumors . Receives: Radiation: Single dose SBRT and VMAT technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity of single fraction SBRT on spine metastases using CTCAE v.4
Measured: 1 year
Local control of the treated lesions using Kaplan-Meyer statistical curves
Measured: 1 year
Secondary outcomes (4)
Pain control at treated sites after RT using CTCAE v.4
Measured: 3 months
Local control of the metastatic disease using Kaplan-Meyer statistical curves
Measured: 3 months
Overall survival of treated patients using Kaplan-Meyer statistical curves
Measured: 1 year
Difference of local and pain control between patients operated on vertebra and non-operated patients using CTCAE v.4
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study start5 Nov 2015
- Primary completion8 Feb 2022
- Study completion8 Feb 2022
Why it stopped: not sufficient patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral MetastasesStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
- Investigators
- Ciro Franzese, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616887
- Sponsor's protocol ID
- 1460
- Status last verified
- May 2022
- First submitted
- 24 Nov 2015
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Image-Guided Single Fraction SBRT With VMAT-FFF Technique for Vertebral Metastases
- ClinicalTrials.gov ID
- NCT02616887
- Acronym / sponsor ID
- 1460
- Conditions
- Vertebral Metastases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: not sufficient patients enrolled
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 5 Nov 2015 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 30 Nov 2015 (estimated)
- 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.
Based on the known efficacy of ablative single dose SBRT and VMAT technique in various solid tumors, investigators have designed this study to assess feasibility of SBRT in selected patients with spine metastases.
Detailed description
This is a prospective, phase 2 study. The main objectives are to assess acute and late side effects of single fraction SBRT for selected patients with vertebral metastases and to study the local control of disease in treated sites.
The schedule will be 1 fraction of 18 Gy delivered in one day with Volumetric Modulated Arc Therapy (VMAT) and Flattening filter-free (FFF) beams.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vertebral metastases | – | Radiation: Single dose SBRT and VMAT techniqueSelected patients with spine metastases are treated with ablative single dose SBRT and VMAT technique in various solid tumors . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with spine metastases
Key inclusion criteria (9 listed)
- Age ≥ 18years.
- WHO performance status ≤ 2 (ECOG - KPS).
- Histologically-proven of primary cancer disease.
- Metastatic disease in the spine, from C1 to Sacrum. A maximum number of 5 sites. Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies.
- Epidural compression is eligible when there is at least 3 mm gap between the spinal cord and the edge of the epidural lesion, unless patient underwent decompression surgery.
Key exclusion criteria (4 listed)
- > 50% loss of vertebral body height.
- Prior radiation to the interested spine.
- Patients for whom an MRI of the spine is medically contraindicated.
- Patients allergic to contrast used in MRIs or CT scans or who cannot be premedicated for the use of contrast.
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 |
|---|---|---|
| Single dose SBRT and VMAT techniqueOne fraction of 18 Gy delivered in one day with VMAT and Flattening filter-free (FFF) beams. | Radiation | Vertebral metastases |
Primary outcome
Toxicity of single fraction SBRT on spine metastases using CTCAE v.4
Time frame: 1 year
Local control of the treated lesions using Kaplan-Meyer statistical curves
Time frame: 1 year
4 secondary outcomes
Pain control at treated sites after RT using CTCAE v.4
Time frame: 3 months
Local control of the metastatic disease using Kaplan-Meyer statistical curves
Time frame: 3 months
Overall survival of treated patients using Kaplan-Meyer statistical curves
Time frame: 1 year
Difference of local and pain control between patients operated on vertebra and non-operated patients using CTCAE v.4
Time frame: 3 months
Results and safety
The study was stopped early (reason given: not sufficient patients enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
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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. This study is not recruiting at the moment.
Ciro Franzese, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Metastases, run by Istituto Clinico Humanitas 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 9 inclusion and 4 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: stopped early, as of the sponsor's last update on 9 May 2022. 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?
The study was stopped early (reason given: not sufficient patients enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity of single fraction SBRT on spine metastases using CTCAE v.4 (time frame: 1 year). The study lists 2 primary outcomes in all. 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 9 May 2022.