Stereotactic radiotherapy on brain metastases with recent hemorrhagic signal: STEREO-HBM, a two-step phase 2 trial.
Paul Lesueur, William Kao, Alexandra Leconte...
https://pubmed.ncbi.nlm.nih.gov/32087691Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID03696680
Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps
Led by Centre Francois Baclesse · Updated on 2025-02-11
46
Participants Needed
4
Research Sites
30 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
Researchers are evaluating the safety and effectiveness of fractionated stereotactic radiotherapy (FSRT) to treat hemorrhagic brain metastases in adults. This Phase 2 trial focuses on patients with recent bleeding within brain metastases and aims to observe complications related to hemorrhage and tumor response after treatment. The study is sponsored by Centre Francois Baclesse and involves patients diagnosed with solid tumors that have spread to the brain. Each brain metastasis, whether hemorrhagic or not, will be treated with FSRT. The treatment consists of delivering a total radiation dose of 30 Gy divided into 3 fractions of 10 Gy each, given over 7 days. Patients eligible for stereotactic radiotherapy are selected by a multidisciplinary committee. The study is conducted in two stages, focusing on patients with specific tumor size and location criteria. Participants will undergo assessments including imaging to monitor for any new or increased bleeding and to evaluate tumor response according to standardized criteria six months after completing radiation therapy. Researchers will also evaluate neurological status, treatment tolerance, and any complications. The total duration of monitoring includes safety and tumor response evaluations at six months post-treatment, with ongoing observation as required by the study protocol.
CONDITIONS
Brief Title
Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Performance status of 0 or 1
- Fewer than 4 brain metastases from a solid tumor, including melanoma, with histological diagnosis
- Brain lesions measuring between 5 and 30 mm in diameter
- Eligible for stereotactic radiotherapy by multidisciplinary committee decision
- Presence of intra-tumor bleeding signals on at least one brain lesion detected by CT or MRI imaging
- No meningeal tumor invasion
- No brainstem metastases
- DS-GPA score meeting minimum thresholds based on tumor type (e.g., 2 or higher for lung adenocarcinoma)
- No concurrent anti-cancer treatments; 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
- Neuropsychological capacity to follow study protocol
- Affiliated with a social security scheme
- Provides written consent
You will not qualify if you...
- Small cell lung cancer, germ cell tumors, lymphoma, leukemia, or multiple myeloma
- Concomitant neurodegenerative disease
- Symptoms unrelated to brain metastases requiring long-term corticosteroids
- Contraindications to brain MRI or gadolinium injection
- Hemorrhagic disorders other than intra-tumor bleeding
- Radiosensitizing systemic diseases such as neurofibromatosis
- Platelet count below 100,000 cells/mm3
- Use of anticoagulant or anti-platelet drugs during FSRT unless paused according to protocol
- Hemorrhagic brainstem metastases
- Radiation planning causing doses over 5 Gy to other metastases simultaneously
- Prior cerebral stereotactic or total brain irradiation
- Conditions that would prevent study participation due to social, psychological, or geographic reasons
- Participation in other therapeutic trials that may interfere
- Legal restrictions such as being deprived of liberty or under guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 7 days
Participants receive stereotactic radiotherapy to treat each cerebral metastasis with a dose of 30 Gy divided into 3 fractions over 7 days.
3 visits (in-person) for radiation treatment
Follow-up
Duration - 6 months
Participants are monitored for hemorrhagic complications and tumor response after completing stereotactic radiotherapy.
Visits as scheduled for assessments up to 6 months after treatment
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
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Research Team
J
Julien GEFRELOT, MD
D
Dinu STEFAN, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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