Actively Recruiting
Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal
Led by Centre Francois Baclesse · Updated on 2025-02-11
46
Participants Needed
4
Research Sites
467 weeks
Total Duration
On this page
Sponsors
C
Centre Francois Baclesse
Lead Sponsor
A
ANOCEF/IGCNO
Collaborating Sponsor
AI-Summary
What this Trial Is About
This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases
CONDITIONS
Official Title
Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Performance Status 0 or 1
- Less than 4 brain metastases from a solid tumor with histological confirmation
- Brain lesions between 5 and 30 mm in diameter
- Eligible for stereotactic radiotherapy as decided by a multidisciplinary committee
- Presence of intra-tumor bleeding signals on at least one brain lesion shown by CT or MRI imaging
- No meningeal tumor invasion
- No brainstem metastasis
- DS-GPA score meeting histology-specific thresholds (e.g., Lung Adenocarcinoma: 2 or higher)
- No concurrent anti-cancer therapy; treatments paused at least 7 days before FSRT and resumed 7 days after
- Life expectancy over 6 months
- Ability to cooperate with treatment using a thermoformed mask
- Sufficient neuropsychological capacity to follow protocol requirements
- Affiliated with a social security scheme
- Provides written informed consent
You will not qualify if you...
- Small cell lung cancer, germ cell tumors, lymphoma, leukemia, or multiple myeloma
- Concomitant neurodegenerative disease
- Symptoms requiring long-term corticosteroids not related to brain metastases or cancer
- Contraindication to brain MRI or gadolinium injection
- Hemorrhagic disorders other than intra-tumor bleeding
- Radiosensitizing systemic diseases like Neurofibromatosis
- Platelet count below 100,000 cells/mm3
- Use of anticoagulant or anti-platelet therapy that cannot be safely paused during FSRT
- Hemorrhagic brainstem metastases
- Radiation plan delivering more than 5 Gy to other metastases simultaneously
- Prior cerebral stereotactic irradiation or whole brain radiation
- Any condition compromising ability to participate or study conduct
- Participation in another therapeutic trial that interferes with this study
- Legal incapacity or guardianship status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Centre de la Baie
Avranches, France
Actively Recruiting
2
Centre François Baclesse
Caen, France
Actively Recruiting
3
Hospices Civils de Lyon
Lyon, France
Actively Recruiting
4
Institut de Cancérologie de Lorraine
Nancy, France
Actively Recruiting
Research Team
J
Julien GEFRELOT, MD
CONTACT
D
Dinu STEFAN, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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