Hemorrhagic Brain MetastasesPhase 2STEREO-HBMNCT03696680
Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal
A Phase 2 study testing FSRT Stereotactic radiation therapy in people with Hemorrhagic Brain Metastases, run by Centre Francois Baclesse at 4 sites in France.
Trial summary
This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhagic Brain Metastases
- What is being tested?
- FSRT Stereotactic radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesFrance
- Study dates
- 16 Jan 2019to Jan 2028
- Phase
- Phase 2
- 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
- Age> 18 years
- Performance Status 0 or 1
- Patient with less than 4 brain metastases [of a solid tumor, including melanoma, with a histologically proven diagnosis for the solid tumor; Patients who have had a metastasectomy and 1 to 3 brain metastatic lesions are eligible.
- Brain injury (s) measuring between 5 and 30 mm in diameter
- Patient eligible for stereotactic radiotherapy after a decision of the multidisciplinary committee
- Presence of intra-tumor bleeding signals on at least one brain injury before stereotactic irradiation and defined by :
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- hyperdense lesion on the non-injected CT (treatment scanner) and / or,
- spontaneously hyperintense lesion on T1 MRI sequences without gadolinium injection and / or,
- lesion with hypo signal on T2 sequences *
- Absence of meningeal tumor invasion
- Absence of brainstem metastasis
- DS-GPA depending on the histological type (https://brainmetgpa.com/#start):
- Lung Adecarcinoma: DS-GPA 2 or +
- Non-adenocarcinoma lung: DS-GPA 2.5 or +
- Kidney: DS-GPA 2.5 or +
- Breast: DS-GPA 2.5 or +
- Digestive cancer: DS-GPA 3 or +
- Melanoma: DS-GPA 1.5 or +
- Patient without concomitant anti-cancer therapy (chemotherapy, hormone therapy, anti-angiogenic or other anti-cancer treatments). Treatments should be suspended for at least 7 days before the start of FSRT radiotherapy. The treatment can be resumed 7 days after the end of radiotherapy. It's not mandatory to suspend immunotherapy
- Life expectancy estimated at over 6 months
- Patient cooperating sufficiently to perform the treatment with the use of a thermoformed mask
- Patient whose neuropsychological capacities make it possible to follow the requirements of the protocol
- Patient affiliated to a social security scheme
- Patient giving written consent
Who cannot join
- Patient with small cell lung cancer, germ cell tumors, lymphoma, leukemia and multiple myeloma
- Patient with a concomitant neurodegenerative disease
- Any symptoms not attributable to cerebral metastasis or cancerous pathology and requiring long-term use of corticosteroids (regardless of dose)
- Contraindication to brain MRI or gadolinium injection
- Hemorrhagic disorders other than intra-tumor bleeding from brain lesion (s)
- Radiosensitizing systemic disease (Neurofibromatosis ...)
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- Thrombocytopenia less than 100,000 cells / mm3
- Anticoagulant treatment, and / or anti-platelet aggregation with curative et prophylaxic dose during FSRT. If treatment can be delayed for at least 5 days before starting FSRT and resumed 2 weeks after completion of FSRT, the patient is eligible.
- Hemorrhagic metastasis (s) of the brainstem
- Planning of the treatment on the target metastasis delivering a dose> 5 Gy on other metastases concomitant
- Patient with prior cerebral stereotactic irradiation
- History of total brain irradiation
- Any associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study
- Participation in a therapeutic trial that could compromise the conduct of study
- Patient deprived of liberty or under guardianship
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Centre de la Baie
Avranches
Victor PERNIN, MD
- Recruiting
Centre François Baclesse
Caen
Julien GEFFRELOT, MD
- Recruiting
Hospices Civils de Lyon
Lyon
Loïc FEUVRET, loic.feuvret@chu-lyon.fr
- Recruiting
Institut de Cancérologie de Lorraine
Nancy
Selima SELLAMI, MD
About this study
Official title: Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps
This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases
- Conditions
- Hemorrhagic Brain Metastases
- Being tested
- FSRT Stereotactic radiation therapy
- Keywords
- hemorrhagic, brain metastases, FSRT, Stereotactic radiation therapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSRT Stereotactic radiation therapyRadiation
For each metastasis, dose of 30 Gy in 3 fractions at 10 Gy / fraction over 7 days
| Study group | Role | What they receive |
|---|---|---|
| FSRT Stereotactic radiation therapy | Experimental | Each cerebral metastasis (hemorrhagic or otherwise) will be treated by radiation Receives: Radiation: FSRT Stereotactic radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage)
Measured: 6 months after end of Stereotactic radiation therapy
Local tumoral response rate defined according to the recommendations of the RECIST criteria
Measured: 6 months after end of Stereotactic radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start16 Jan 2019
- Primary completionJun 2027 (estimated)
- Study completionJan 2028 (estimated)
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 Hemorrhagic 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- ANOCEF/IGCNO, Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696680
- Sponsor's protocol ID
- 2018-A00926-49
- Acronym
- STEREO-HBM
- Status last verified
- Feb 2025
- First submitted
- 3 Oct 2018
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lesueur P, Kao W, Leconte A, Geffrelot J, Lequesne J, Lacroix J, Brachet PE, Hrab I, Royer P, Clarisse B, Stefan D. Stereotactic radiotherapy on brain metastases with recent hemorrhagic signal: STEREO-HBM, a two-step phase 2 trial. BMC Cancer. 2020 Feb 22;20(1):147. doi: 10.1186/s12885-020-6569-1.
PubMed 32087691
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps
- ClinicalTrials.gov ID
- NCT03696680
- Acronym / sponsor ID
- STEREO-HBM / 2018-A00926-49
- Conditions
- Hemorrhagic Brain Metastases
- Keywords
- hemorrhagic, brain metastases, FSRT, Stereotactic radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- ANOCEF/IGCNO, Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 5 Oct 2018 (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.
This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic 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 |
|---|---|---|
| FSRT Stereotactic radiation therapy | Experimental | Radiation: FSRT Stereotactic radiation therapyEach cerebral metastasis (hemorrhagic or otherwise) will be treated by radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age> 18 years
- Performance Status 0 or 1
- Patient with less than 4 brain metastases [of a solid tumor, including melanoma, with a histologically proven diagnosis for the solid tumor; Patients who have had a metastasectomy and 1 to 3 brain metastatic lesions are eligible.
- Brain injury (s) measuring between 5 and 30 mm in diameter
- Patient eligible for stereotactic radiotherapy after a decision of the multidisciplinary committee
Key exclusion criteria (15 listed)
- Patient with small cell lung cancer, germ cell tumors, lymphoma, leukemia and multiple myeloma
- Patient with a concomitant neurodegenerative disease
- Any symptoms not attributable to cerebral metastasis or cancerous pathology and requiring long-term use of corticosteroids (regardless of dose)
- Contraindication to brain MRI or gadolinium injection
- Hemorrhagic disorders other than intra-tumor bleeding from brain lesion (s)
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 |
|---|---|---|
| FSRT Stereotactic radiation therapyFor each metastasis, dose of 30 Gy in 3 fractions at 10 Gy / fraction over 7 days | Radiation | FSRT Stereotactic radiation therapy |
Primary outcome
Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage)
Time frame: 6 months after end of Stereotactic radiation therapy
Local tumoral response rate defined according to the recommendations of the RECIST criteria
Time frame: 6 months after end of Stereotactic radiation therapy
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 Feb 2025.
- Derived from this study: PubMed 32087691Lesueur P, Kao W, Leconte A, Geffrelot J, Lequesne J, Lacroix J, Brachet PE, Hrab I, Royer P, Clarisse B, Stefan D. Stereotactic radiotherapy on brain metastases with recent hemorrhagic signal: STEREO-HBM, a two-step phase 2 trial. BMC Cancer. 2020 Feb 22;20(1):147. doi: 10.1186/s12885-020-6569-1.
- 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.
4 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 FSRT Stereotactic radiation therapy in people with Hemorrhagic Brain Metastases, run by Centre Francois Baclesse at 4 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 24 inclusion and 15 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 11 Feb 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 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?
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 Julien GEFRELOT, MD (0231455020, j.geffrelot@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage) (time frame: 6 months after end of Stereotactic radiation therapy). 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?
On the ClinicalTrials.gov record for NCT03696680, 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 11 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.