Stereotactic radiotherapy for brain metastases with bleeding
Official title: Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps
Run by Centre Francois Baclesse · NCT03696680 · Data updated 2026-11-12
This study is testing if a special type of targeted radiation therapy can safely help people with bleeding brain tumors caused by cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Centre Francois Baclesse Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 4 sites (Avranches and 3 other locations) |
| Status | Recruiting |
| Started | January 16, 2019 |
| Main results expected | June 2027 |
| Study ends | January 2028 |
| Registry record updated | February 11, 2025 |
| Trial ID | NCT03696680 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with less than 4 brain metastases and specific imaging characteristics indicating intra-tumor bleeding.
✕Probably not a fit
Patients with meningeal tumor invasion or brainstem metastasis will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 trial evaluates the safety and efficacy of Fractionated Stereotactic Radiotherapy (FSRT) for patients with hemorrhagic brain metastases. It is a prospective, non-randomized study that focuses on patients with specific eligibility criteria, including age, performance status, and the presence of intra-tumor bleeding signals. The trial aims to assess how well FSRT can manage these complex cases of brain metastases, which are often challenging to treat. Participants will be monitored for treatment outcomes and safety throughout the study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective management option for patients with hemorrhagic brain metastases.
How similar studies have gone: While there have been studies on stereotactic radiotherapy for brain metastases, this specific approach for hemorrhagic cases is relatively novel and less explored.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 + * 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 Exclusion Criteria: * 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
Where it's running
-
Centre de la Baie
Avranches, France Recruiting -
Centre François Baclesse
Caen, France Recruiting -
Hospices Civils de Lyon
Lyon, France Recruiting -
Institut de Cancérologie de Lorraine
Nancy, France Recruiting
Study contacts
- Study coordinator: Julien GEFRELOT, MD
- Email: j.geffrelot@baclesse.unicancer.fr
- Phone: 0231455020
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.