Brain MetastasesSTEREOMICNCT06869460
Multicenter Retrospective Study on Patients Treated with Stereotactic Radiosurgery/Radiotherapy for Single Brain Lesions: Evaluation of Treatment Efficacy and Safety, Also Through Radiomic Analysis Methods.
An observational study of Brain Metastases and Radiotherapy Side Effect, run by Gemelli Molise Hospital at 4 sites in Italy.
Trial summary
The study design concerns all patients diagnosed witha singular brain metastasis who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Radiotherapy Side Effect
- What is being tested?
- Stereotactic Body Radiotherapy/Radiosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 372 participants
- Where
- 4 sitesItaly
- Study dates
- 20 Feb 2024to 31 Dec 2025
- Phase
- Observational
- 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
Study population: The study design concerns all patients diagnosed with brain metastases who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022.
Who may be able to join
- Age ≥ 18 years
- Treatment with SRS/SRT techniques for a single secondary brain lesion
- Availability of pre-RT brain MRI with contrast (1mm slice thickness)
- Availability of CT simulation imaging for treatment
- Availability of relevant clinical data in the medical record for the study's objectives
- Follow-up of at least 6 months after the completion of SRS or SRT
- Follow-up evaluation through brain MRI
Who cannot join
- Age under 18 years
- Lack of clinical/radiological data for the patient
- Unavailability of the required imaging
- Previous whole-brain radiotherapy treatment
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Responsible Research Hospital
Campobasso, Molise, 80017
IRCCS Ospedale San Raffaele
Milan, Lombardy
INT IRCCS Fondazione G. Pascale Napoli
Naples, Campania
Presidio Ospedaliero "S. G. Moscati"
Taranto, Apulia
About this study
Official title: STEREOMIC: Studio Retrospettivo Multicentrico Su Pazienti Trattati Con Radiochirurgia/Radioterapia STEREotassica Per Lesioni Encefaliche Singole. Valutazione Di Efficacy E Safety Del Trattamento Anche Mediante Metodiche Di Analisi RadiOMICa
The study design concerns all patients diagnosed witha singular brain metastasis who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022
Read the detailed description
The study will include patients of both sexes diagnosed with single brain metastases who underwent radiosurgical/stereotactic treatment. Attention will be paid to data related to local control, potential recurrence, and/or radionecrosis. Once a sufficient number of treated patients is reached, the feasibility of a radiomic feature analysis will be assessed in order to identify potential correlations and/or predictive values for treatment response or radionecrosis. If the sample size is adequate, participating centers will be asked to share pre- and post-RT MRI (brain MRI with contrast using thin slices) and treatment volumes for radiomic evaluation.
- Conditions
- Brain Metastases, Radiotherapy Side Effect
- Being tested
- Stereotactic Body Radiotherapy/Radiosurgery
- Keywords
- Brain metastases, Radiotherapy, Stereotactic Body Radiotherapy, Radiosurgery, Radionecrosis, Local Control, Safety profile, Radiomics
- Medical subject headings
- Brain Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiotherapy/RadiosurgeryRadiation
Also called SBRT/SRS
Stereotactic Body Radiotherapy/Radiosurgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with a singular brain metastases | The study design concerns all patients diagnosed with brain metastases who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022 Receives: Radiation: Stereotactic Body Radiotherapy/Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity profile
"The toxicity profile of the treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute."
Measured: due to the retrospective nature of the study, we did not have specific time points.We will evaluate the possible onset of toxicity events from the last day of treatment up to 18 months from the treatment
Local control
It will be Calculated 'per lesion,' and it is defined as the time interval between irradiation and the onset of disease recurrence at the site of the treated area
Measured: We will evaluate Lc at one, two, and five years from the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start20 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gemelli Molise Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donato Pezzulla, M.D., Principal investigator, Responsible Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869460
- Sponsor's protocol ID
- CET20-02-2024
- Acronym
- STEREOMIC
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STEREOMIC: Studio Retrospettivo Multicentrico Su Pazienti Trattati Con Radiochirurgia/Radioterapia STEREotassica Per Lesioni Encefaliche Singole. Valutazione Di Efficacy E Safety Del Trattamento Anche Mediante Metodiche Di Analisi RadiOMICa
- ClinicalTrials.gov ID
- NCT06869460
- Acronym / sponsor ID
- STEREOMIC / CET20-02-2024
- Conditions
- Brain Metastases, Radiotherapy Side Effect
- Keywords
- Brain metastases, Radiotherapy, Stereotactic Body Radiotherapy, Radiosurgery, Radionecrosis, Local Control, Safety profile, Radiomics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Gemelli Molise HospitalUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Mar 2025 (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.
The study design concerns all patients diagnosed witha singular brain metastasis who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022
Detailed description
The study will include patients of both sexes diagnosed with single brain metastases who underwent radiosurgical/stereotactic treatment. Attention will be paid to data related to local control, potential recurrence, and/or radionecrosis. Once a sufficient number of treated patients is reached, the feasibility of a radiomic feature analysis will be assessed in order to identify potential correlations and/or predictive values for treatment response or radionecrosis. If the sample size is adequate, participating centers will be asked to share pre- and post-RT MRI (brain MRI with contrast using thin slices) and treatment volumes for radiomic evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a singular brain metastases | – | Radiation: Stereotactic Body Radiotherapy/RadiosurgeryThe study design concerns all patients diagnosed with brain metastases who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study design concerns all patients diagnosed with brain metastases who underwent stereotactic radiosurgery/radiotherapy between January 2010 and December 2022.
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Treatment with SRS/SRT techniques for a single secondary brain lesion
- Availability of pre-RT brain MRI with contrast (1mm slice thickness)
- Availability of CT simulation imaging for treatment
- Availability of relevant clinical data in the medical record for the study's objectives
Key exclusion criteria (4 listed)
- Age under 18 years
- Lack of clinical/radiological data for the patient
- Unavailability of the required imaging
- Previous whole-brain radiotherapy treatment
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 Radiotherapy/RadiosurgeryAlso: SBRT/SRSStereotactic Body Radiotherapy/Radiosurgery | Radiation | Patients with a singular brain metastases |
Primary outcome
Toxicity profile
Time frame: due to the retrospective nature of the study, we did not have specific time points.We will evaluate the possible onset of toxicity events from the last day of treatment up to 18 months from the treatment
"The toxicity profile of the treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute."
Local control
Time frame: We will evaluate Lc at one, two, and five years from the treatment
It will be Calculated 'per lesion,' and it is defined as the time interval between irradiation and the onset of disease recurrence at the site of the treated area
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 11 Mar 2025.
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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.
Donato Pezzulla, M.D. principal investigator
Responsible Research Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases and Radiotherapy Side Effect, run by Gemelli Molise Hospital at 4 sites 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 7 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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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 profile (time frame: due to the retrospective nature of the study, we did not have specific time points.We will evaluate the possible onset of toxicity events from the last day of treatment up to 18 months from the treatment). 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 11 Mar 2025.