Brain MetastasesPhase 2STEPNCT04503772
Preoperative Stereotactic Radiosurgery for Brain Metastases
A Phase 2 study testing Preoperative SRS in people with Brain Metastases, run by Centre Jean Perrin at 8 sites in France.
Trial summary
STEP is a French multicentre, prospective, non-randomized, phase II study designed to assess 6-months local control after pre-operative stereotactic radiosurgery (SRS) for patients with brain metastases Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Preoperative SRS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 8 sitesFrance
- Study dates
- 4 Feb 2021to 25 Nov 2025
- Phase
- Phase 2
- 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
Who may be able to join
- ≤ 4 distinct brain metastases, one with surgical indication
- Diagnosis of primary histologically proven breast, digestive or non-small cells lung cancer
- ≤ 5 cm larger diameter
- Karnofsky performance status ≥ 70
- No contraindication for MRI
- Possibility for the patient to be treat with both surgery and stereotactic radiotherapy
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- ≥ 18 years old
- Estimated overall survival ≥ 6 months according to diagnosis specific - graded prognostic assessment (DS GPA)
- Written inform consent signed
- Affiliation to the French social security system
- For women of childbearing age including those on luteinizing hormone-releasing hormone (LH-RH) agonists for ovarian suppression: inclusion negative serum pregnancy test (≤ 7 days prior to the start of preoperative stereotactic radiosurgery (SRS).
Who cannot join
- Lymphoma, leukaemia, multiple myeloma, germinal tumours or cerebral primary cancer
- Metastases from small-cells lung cancer, kidney cancer, melanoma or sarcoma
- Mass effect with deflection ≥ 5 mm from median line or hydrocephaly or compression 4th ventricle, patient neurologically unstable, need for emergency decompressive surgery
- > 4 brain metastases
- Contraindication to anaesthesia, MRI or gadolinium injection
- Proximity of the tumour with organs at risk which do not allow the prescribed dose to be reached in the envelope
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- Pregnant or breastfeeding woman
- Anti vascular endothelial growth factor (VEGF) within 6 weeks before treatment
- Documented leptomeningeal injury
- History of irradiation of the encephalon in toto
- History of stereotactic radiotherapy on metastasis to be operated on
- Non-candidate patient for surgery
- Surgical delay > 3 days compared to stereotactic radiotherapy
- Estimated survival < 6 months by DS GPA
- Patient under guardianship or curators
- Psychological disorder (cognitive disorders, mental alertness, etc.) or social (deprivation of liberty by judicial or administrative decision) or geographical reasons that may compromise medical monitoring of the trial or compliance with treatment
- Woman of childbearing age without effective contraception
- Patient participating in another intervention study within 4 weeks prior to inclusion
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Centre Jean PERRIN
Clermont-Ferrand, Puy-de-Dôme, 63800
CHU Grenoble Alpes
Grenoble, 38700
Hospices Civils de Lyon
Lyon, 69002
Centre Léon BÉRARD
Lyon, 69373
Centre Hospitalier d'Annecy-Genevois
Metz-Tessy, 74370
Institut de Cancérologie de l'Ouest
Saint-Herblain
Institut de cancérologie de la Loire Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg, 67000
About this study
Official title: Phase II Study to Assess Preoperative Hypofractionated Stereotactic Radiotherapy of Brain Metastases
STEP is a French multicentre, prospective, non-randomized, phase II study designed to assess 6-months local control after pre-operative stereotactic radiosurgery (SRS) for patients with brain metastases
- Conditions
- Brain Metastases
- Being tested
- Preoperative SRS
- Keywords
- brain metastases, preoperative stereotactic radiosurgery, local control, radionecrosis, overall survival
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative SRSProcedure or surgery
Patient will be treat with preoperative SRS and then surgery for brain metastases is realized within 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm (all patients) | Experimental | Patients will receive preoperative hypofractionated stereotactic radiosurgery (SRS).
According to the association of french-speaking neuro-oncologists (ANOCEF) recommendations, total dose and fractionation will be 33 Gy in 3 fractions at the isocenter, 23.1 Gy in envelope (70% isodose), i.e. 30 Gy in growth tumor volume (GTV) envelope.) Surgery will take place within 3 days of the preoperative SRS. Receives: Procedure: Preoperative SRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of 6-months local control rate after preoperative SRS
Local recurrence is defined as the onset or progression of nodular contrast grafting within the resection cavity according to the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.
Measured: 6 months after preoperative SRS (M6)
Secondary outcomes (9)
Evaluation of 1-year local control rate after preoperative SRS
Local recurrence is defined as the onset or progression of nodular contrast grafting within the resection cavity according to the RANO-BM criteria.
Measured: 12 months after preoperative SRS (M12)
Evaluation of 1-year radionecrosis rate after preoperative SRS
Radionecrosis is defined either histologically post-operatively according to the anatomopathological report or in the absence of salvage surgery by the appearance or increase of gadolinium contrast on T1 MRI sequences associated with an increase in the cerebral brain volume (CBV) ratio (brain blood volume of the tumour / brain blood volume of the non-tumour white matter) of less than 2 on perfusion MRI sequences and/or a standard uptake volume (SUV max) of less than 1, 59 on positron emission tomography (PET) scanners at 6-fluoro-[18 fluoro]-L-dihydroxyphenylalanine (F-DOPA)
Measured: 12 months after preoperative SRS (M12)
Evaluation of overall survival
defined as the time interval between the date of preoperative radiosurgery and the date of death from any cause.
Measured: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Evaluation of acute (less than 3 months post preoperative SRS) and delayed toxicities (more than 3 months after preoperative SRS)
They will be collected and graded according to the NCI-CTCAE v5.0 scale. An adverse event of grade ≥ 3 will be considered "severe".
Measured: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Rate of leptomeningeal relapses
According to cerebral MRI
Measured: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Evaluation of cerebral distant control
Follow by MRI
Measured: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Determination of predictive factors for local brain control, complication and prognosis factors for survival
Measured: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Evaluation of cognitive function
Mini-mental state examination (MMSE)
Measured: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Evaluation of quality of life
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30)
Measured: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start4 Feb 2021
- Primary completion19 May 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
- Investigators
- Lucie BRUN, MD, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503772
- Sponsor's protocol ID
- 2020-A00403-36
- Other IDs
- 20.06.16-36701
- Acronym
- STEP
- Status last verified
- Nov 2025
- First submitted
- 4 Aug 2020
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ginzac A, Dupic G, Brun L, Molnar I, Casile M, Durando X, Verrelle P, Lemaire JJ, Khalil T, Biau J. Preoperative stereotactic radiosurgery for brain metastases: the STEP study protocol for a multicentre, prospective, phase-II trial. BMC Cancer. 2021 Jul 28;21(1):864. doi: 10.1186/s12885-021-08602-0.
PubMed 34320940
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Assess Preoperative Hypofractionated Stereotactic Radiotherapy of Brain Metastases
- ClinicalTrials.gov ID
- NCT04503772
- Acronym / sponsor ID
- STEP / 2020-A00403-36
- Conditions
- Brain Metastases
- Keywords
- brain metastases, preoperative stereotactic radiosurgery, local control, radionecrosis, overall survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 7 Aug 2020 (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.
STEP is a French multicentre, prospective, non-randomized, phase II study designed to assess 6-months local control after pre-operative stereotactic radiosurgery (SRS) for patients with brain metastases
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm (all patients) | Experimental | Procedure: Preoperative SRSPatients will receive preoperative hypofractionated stereotactic radiosurgery (SRS). According to the association of french-speaking neuro-oncologists (ANOCEF) recommendations, total dose and fractionation will be 33 Gy in 3 fractions at the isocenter, 23.1 Gy in envelope (70% isodose), i.e. 30 Gy in growth tumor volume (GTV) envelope.) Surgery will take place within 3 days of the preoperative SRS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≤ 4 distinct brain metastases, one with surgical indication
- Diagnosis of primary histologically proven breast, digestive or non-small cells lung cancer
- ≤ 5 cm larger diameter
- Karnofsky performance status ≥ 70
- No contraindication for MRI
Key exclusion criteria (18 listed)
- Lymphoma, leukaemia, multiple myeloma, germinal tumours or cerebral primary cancer
- Metastases from small-cells lung cancer, kidney cancer, melanoma or sarcoma
- Mass effect with deflection ≥ 5 mm from median line or hydrocephaly or compression 4th ventricle, patient neurologically unstable, need for emergency decompressive surgery
- > 4 brain metastases
- Contraindication to anaesthesia, MRI or gadolinium injection
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 |
|---|---|---|
| Preoperative SRSPatient will be treat with preoperative SRS and then surgery for brain metastases is realized within 3 days. | Procedure or surgery | Experimental arm (all patients) |
Primary outcome
Evaluation of 6-months local control rate after preoperative SRS
Time frame: 6 months after preoperative SRS (M6)
Local recurrence is defined as the onset or progression of nodular contrast grafting within the resection cavity according to the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.
9 secondary outcomes
Evaluation of 1-year local control rate after preoperative SRS
Time frame: 12 months after preoperative SRS (M12)
Evaluation of 1-year radionecrosis rate after preoperative SRS
Time frame: 12 months after preoperative SRS (M12)
Evaluation of overall survival
Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Evaluation of acute (less than 3 months post preoperative SRS) and delayed toxicities (more than 3 months after preoperative SRS)
Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Rate of leptomeningeal relapses
Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Evaluation of cerebral distant control
Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Determination of predictive factors for local brain control, complication and prognosis factors for survival
Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Evaluation of cognitive function
Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Evaluation of quality of life
Time frame: At each follow-up visits after preoperative SRS : +3 months (M3); +6 months (M6); +9 months (M9); +12 months (M12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 34320940Ginzac A, Dupic G, Brun L, Molnar I, Casile M, Durando X, Verrelle P, Lemaire JJ, Khalil T, Biau J. Preoperative stereotactic radiosurgery for brain metastases: the STEP study protocol for a multicentre, prospective, phase-II trial. BMC Cancer. 2021 Jul 28;21(1):864. doi: 10.1186/s12885-021-08602-0.
- Study protocol articleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Lucie BRUN, MD principal investigator
Centre Jean Perrin
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Preoperative SRS in people with Brain Metastases, run by Centre Jean Perrin at 8 sites 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 11 inclusion and 18 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: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of 6-months local control rate after preoperative SRS (time frame: 6 months after preoperative SRS (M6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04503772, which also lists 1 linked publication.
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 4 Dec 2025.