Hemorrhagic Brain Metastases
Conditions
Keywords
hemorrhagic, brain metastases, FSRT, Stereotactic radiation therapy
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
Interventions
RADIATIONFSRT Stereotactic radiation therapy
For each metastasis, dose of 30 Gy in 3 fractions at 10 Gy / fraction over 7 days
Sponsors
Centre Francois Baclesse
ANOCEF/IGCNO
Groupement Interrégional de Recherche Clinique et d'Innovation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Contacts
Primary ContactJulien GEFRELOT, MD
Backup ContactDinu STEFAN, MD
Outcome results
None listed