Stereotactic radiotherapy for brain metastases with bleeding
Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps
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 |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Francois Baclesse Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 4 sites (Avranches and 3 other locations) |
| Trial ID | NCT03696680 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with less than 4 brain metastases and specific imaging characteristics indicating intra-tumor bleeding.
Not a fit: Patients with meningeal tumor invasion or brainstem metastasis will not benefit from this 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 performed: While there have been studies on stereotactic radiotherapy for brain metastases, this specific approach for hemorrhagic cases is relatively novel and less explored.
Eligibility criteria
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 this trial is running
Avranches and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.