Brain Metastases, AdultNeoSRSNCT07437820
Study Comparing Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy of Brain Metastases
A study testing stereotactic radiotherapy and Excision surgery in people with Brain Metastases, Adult, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The purpose of this study is to evaluate the local control rate on the target lesion at 6, 12, and 24 months after treatment with neoadjuvant stereotactic radiotherapy (SRS NEO group) compared to standard care, adjuvant stereotactic radiotherapy (POST OP SRS group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Adult
- What is being tested?
- stereotactic radiotherapy and Excision surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to 30 Jun 2030
- 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 aged 18 years and older;
- Patients with 1 to 12 brain metastases on preoperative MRI, at least one of which (contrast enhancement of at least 1 cm) is accessible for the most complete possible resection (target lesion);
- Patients with a Karnofsky performance score of ≥ 70;
- Patients able to perform neurocognitive tests without assistance;
- Patients who understand the study and agree to attend all visits;
- Patients who have signed a written informed consent form;
- Affiliation with a social security system.
Who cannot join
- Patient who has already been treated with surgery, radiosurgery, and/or radiotherapy for the target brain metastasis;
- Medical contraindication to MRI;
- Patient with an estimated life expectancy of ≤ 3 months;
- Patients participating in another clinical trial, or who are in the exclusion period of another clinical trial;
- Patients unable to complete a self-administered questionnaire;
- Patients from a vulnerable population.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Privé Clairval
Marseille, 13273
Philippe METELLUS, MD, 04 91 17 14 83 ext. +33, philippe.metellus@outlook.fr
About this study
Official title: Prospective, Randomized, Multicenter Study Comparing the Efficacy and Tolerance of Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy in the Management of Brain Metastases
The purpose of this study is to evaluate the local control rate on the target lesion at 6, 12, and 24 months after treatment with neoadjuvant stereotactic radiotherapy (SRS NEO group) compared to standard care, adjuvant stereotactic radiotherapy (POST OP SRS group).
Read the detailed description
This is a phase III, prospective, multicenter, randomized, two-group, controlled, open-label interventional study designed to evaluate the efficacy in terms of local progression-free survival of neoadjuvant stereotactic radiotherapy for brain metastases compared with adjuvant stereotactic radiotherapy.
The study population is composed of adult patients with 1 to 12 newly diagnosed brain metastases who require surgical treatment for the removal of at least one lesion.
The two therapeutic strategies studied in the trial are as follows:
- SRS NEO group (experimental group): stereotactic radiotherapy administered as neoadjuvant therapy (4 days ± 1 day before surgery to remove the brain metastasis).
- POST OP SRS group (control group): stereotactic radiotherapy performed adjuvantly (4 to 6 weeks after surgery to remove the brain metastasis).
- Conditions
- Brain Metastases, Adult
- Being tested
- stereotactic radiotherapy, Excision surgery
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic radiotherapyRadiation
Stereotactic radiotherapy is part of the standard treatment for brain metastases.
Excision surgeryProcedure or surgery
Brain metastasis removal surgery
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant stereotactic radiotherapy | Experimental | Innovative treatment with neoadjuvant stereotactic radiotherapy, with the protocol requiring SRS to be performed 4 days ± 1 day before surgery to remove the target brain metastasis.
Neuronavigation magnetic resonance imaging and a tracking scan, necessary for contouring the lesions and creating the treatment mask, will be performed within 7 days prior to the start of radiotherapy. These examinations are essential regardless of the type of stereotactic radiotherapy (adjuvant or neoadjuvant) and are routinely performed for lesion contouring. Receives: Radiation: stereotactic radiotherapy; Procedure: Excision surgery |
| Control group : adjuvant stereotactic radiotherapy | Active comparator | Standard care in accordance with the gold standard, with stereotactic radiotherapy performed as an adjunct to the surgical bed of the targeted lesion, i.e., 4 to 6 weeks after surgery. Neuronavigation magnetic resonance imaging and a tracking scan, necessary for contouring the lesions and creating the treatment mask, will be performed within 7 days prior to the start of radiotherapy. Receives: Radiation: stereotactic radiotherapy; Procedure: Excision surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control rate of the target lesion
The local control rate of the target lesion will be determined by the percentage of lesions that have recurred locally. Local progression will be defined, for the treated metastatic lesion, by the appearance on follow-up magnetic resonance imaging of contrast enhancement in the surgical cavity, according to the criteria for assessing response in neuro-oncology of brain metastases.
Measured: 6 months
Local control rate of the target lesion
The local control rate of the target lesion will be determined by the percentage of lesions that have recurred locally. Local progression will be defined, for the treated metastatic lesion, by the appearance on follow-up magnetic resonance imaging of contrast enhancement in the surgical cavity, according to the criteria for assessing response in neuro-oncology of brain metastases.
Measured: 12 months
Local control rate of the target lesion
The local control rate of the target lesion will be determined by the percentage of lesions that have recurred locally. Local progression will be defined, for the treated metastatic lesion, by the appearance on follow-up magnetic resonance imaging of contrast enhancement in the surgical cavity, according to the criteria for assessing response in neuro-oncology of brain metastases.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startSep 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases, AdultStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III, prospective, multicenter, randomized, two-group, controlled, open-label interventional study
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437820
- Sponsor's protocol ID
- 2025-A02642-47
- Acronym
- NeoSRS
- Status last verified
- Aug 2026
- First submitted
- 23 Feb 2026
- Last updated
- 25 Aug 2026
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multicenter Study Comparing the Efficacy and Tolerance of Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy in the Management of Brain Metastases
- ClinicalTrials.gov ID
- NCT07437820
- Acronym / sponsor ID
- NeoSRS / 2025-A02642-47
- Conditions
- Brain Metastases, Adult
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- Sep 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 27 Feb 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.
The purpose of this study is to evaluate the local control rate on the target lesion at 6, 12, and 24 months after treatment with neoadjuvant stereotactic radiotherapy (SRS NEO group) compared to standard care, adjuvant stereotactic radiotherapy (POST OP SRS group).
Detailed description
This is a phase III, prospective, multicenter, randomized, two-group, controlled, open-label interventional study designed to evaluate the efficacy in terms of local progression-free survival of neoadjuvant stereotactic radiotherapy for brain metastases compared with adjuvant stereotactic radiotherapy.
The study population is composed of adult patients with 1 to 12 newly diagnosed brain metastases who require surgical treatment for the removal of at least one lesion.
The two therapeutic strategies studied in the trial are as follows:
- SRS NEO group (experimental group): stereotactic radiotherapy administered as neoadjuvant therapy (4 days ± 1 day before surgery to remove the brain metastasis).
- POST OP SRS group (control group): stereotactic radiotherapy performed adjuvantly (4 to 6 weeks after surgery to remove the brain metastasis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase III, prospective, multicenter, randomized, two-group, controlled, open-label interventional study
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant stereotactic radiotherapy | Experimental | Radiation: stereotactic radiotherapy, Procedure: Excision surgeryInnovative treatment with neoadjuvant stereotactic radiotherapy, with the protocol requiring SRS to be performed 4 days ± 1 day before surgery to remove the target brain metastasis. Neuronavigation magnetic resonance imaging and a tracking scan, necessary for contouring the lesions and creating the treatment mask, will be performed within 7 days prior to the start of radiotherapy. These examinations are essential regardless of the type of stereotactic radiotherapy (adjuvant or neoadjuvant) and are routinely performed for lesion contouring. |
| Control group : adjuvant stereotactic radiotherapy | Active comparator | Radiation: stereotactic radiotherapy, Procedure: Excision surgeryStandard care in accordance with the gold standard, with stereotactic radiotherapy performed as an adjunct to the surgical bed of the targeted lesion, i.e., 4 to 6 weeks after surgery. Neuronavigation magnetic resonance imaging and a tracking scan, necessary for contouring the lesions and creating the treatment mask, will be performed within 7 days prior to the start of radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18 years and older;
- Patients with 1 to 12 brain metastases on preoperative MRI, at least one of which (contrast enhancement of at least 1 cm) is accessible for the most complete possible resection (target lesion);
- Patients with a Karnofsky performance score of ≥ 70;
- Patients able to perform neurocognitive tests without assistance;
- Patients who understand the study and agree to attend all visits;
Key exclusion criteria (6 listed)
- Patient who has already been treated with surgery, radiosurgery, and/or radiotherapy for the target brain metastasis;
- Medical contraindication to MRI;
- Patient with an estimated life expectancy of ≤ 3 months;
- Patients participating in another clinical trial, or who are in the exclusion period of another clinical trial;
- Patients unable to complete a self-administered questionnaire;
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 radiotherapyStereotactic radiotherapy is part of the standard treatment for brain metastases. | Radiation | Control group : adjuvant stereotactic radiotherapy, Neoadjuvant stereotactic radiotherapy |
| Excision surgeryBrain metastasis removal surgery | Procedure or surgery | Control group : adjuvant stereotactic radiotherapy, Neoadjuvant stereotactic radiotherapy |
Primary outcome
Local control rate of the target lesion
Time frame: 6 months
The local control rate of the target lesion will be determined by the percentage of lesions that have recurred locally. Local progression will be defined, for the treated metastatic lesion, by the appearance on follow-up magnetic resonance imaging of contrast enhancement in the surgical cavity, according to the criteria for assessing response in neuro-oncology of brain metastases.
Local control rate of the target lesion
Time frame: 12 months
The local control rate of the target lesion will be determined by the percentage of lesions that have recurred locally. Local progression will be defined, for the treated metastatic lesion, by the appearance on follow-up magnetic resonance imaging of contrast enhancement in the surgical cavity, according to the criteria for assessing response in neuro-oncology of brain metastases.
Local control rate of the target lesion
Time frame: 24 months
The local control rate of the target lesion will be determined by the percentage of lesions that have recurred locally. Local progression will be defined, for the treated metastatic lesion, by the appearance on follow-up magnetic resonance imaging of contrast enhancement in the surgical cavity, according to the criteria for assessing response in neuro-oncology of brain metastases.
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 25 Aug 2026.
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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 radiotherapy and Excision surgery in people with Brain Metastases, Adult, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 6 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: opening soon, as of the sponsor's last update on 25 Aug 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 France. 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 Philippe METELLUS, MD (04 91 17 14 83 ext. +33, philippe.metellus@outlook.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control rate of the target lesion (time frame: 6 months). The study lists 3 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 25 Aug 2026.