Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal
STEREO-HBM
1 other identifier
interventional
46
1 country
4
Brief Summary
This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2019
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2018
CompletedFirst Posted
Study publicly available on registry
October 5, 2018
CompletedStudy Start
First participant enrolled
January 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
February 11, 2025
February 1, 2025
8.4 years
October 3, 2018
February 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage)
6 months after end of Stereotactic radiation therapy
Local tumoral response rate defined according to the recommendations of the RECIST criteria
6 months after end of Stereotactic radiation therapy
Study Arms (1)
FSRT Stereotactic radiation therapy
EXPERIMENTALEach cerebral metastasis (hemorrhagic or otherwise) will be treated by radiation
Interventions
For each metastasis, dose of 30 Gy in 3 fractions at 10 Gy / fraction over 7 days
Eligibility Criteria
You may qualify if:
- 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 :
- 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 +
- +9 more criteria
You may not qualify if:
- 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 ...)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Francois Baclesselead
- ANOCEF/IGCNOcollaborator
- Groupement Interrégional de Recherche Clinique et d'Innovationcollaborator
Study Sites (4)
Centre de la Baie
Avranches, France
Centre François Baclesse
Caen, France
Hospices Civils de Lyon
Lyon, France
Institut de Cancérologie de Lorraine
Nancy, France
Related Publications (1)
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.
PMID: 32087691DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2018
First Posted
October 5, 2018
Study Start
January 16, 2019
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
February 11, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share