[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemorrhagic-brain-metastases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemorrhagic-brain-metastases":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100339221","phase-2-stereotactic-radiotherapy-for-cerebral-metastases-with-recent-hemorrhagic-signal-100339221",false,"NCT03696680","Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal","Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps","STEREO-HBM","Inclusion Criteria:\n\n* Age\\> 18 years\n* Performance Status 0 or 1\n* 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.\n* Brain injury (s) measuring between 5 and 30 mm in diameter\n* Patient eligible for stereotactic radiotherapy after a decision of the multidisciplinary committee\n* Presence of intra-tumor bleeding signals on at least one brain injury before stereotactic irradiation and defined by :\n\n  * hyperdense lesion on the non-injected CT (treatment scanner) and \u002F or,\n  * spontaneously hyperintense lesion on T1 MRI sequences without gadolinium injection and \u002F or,\n  * lesion with hypo signal on T2 sequences \\*\n* Absence of meningeal tumor invasion\n* Absence of brainstem metastasis\n* DS-GPA depending on the histological type (https:\u002F\u002Fbrainmetgpa.com\u002F#start):\n\n  * Lung Adecarcinoma: DS-GPA 2 or +\n  * Non-adenocarcinoma lung: DS-GPA 2.5 or +\n  * Kidney: DS-GPA 2.5 or +\n  * Breast: DS-GPA 2.5 or +\n  * Digestive cancer: DS-GPA 3 or +\n  * Melanoma: DS-GPA 1.5 or +\n* 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\n* Life expectancy estimated at over 6 months\n* Patient cooperating sufficiently to perform the treatment with the use of a thermoformed mask\n* Patient whose neuropsychological capacities make it possible to follow the requirements of the protocol\n* Patient affiliated to a social security scheme\n* Patient giving written consent\n\nExclusion Criteria:\n\n* Patient with small cell lung cancer, germ cell tumors, lymphoma, leukemia and multiple myeloma\n* Patient with a concomitant neurodegenerative disease\n* Any symptoms not attributable to cerebral metastasis or cancerous pathology and requiring long-term use of corticosteroids (regardless of dose)\n* Contraindication to brain MRI or gadolinium injection\n* Hemorrhagic disorders other than intra-tumor bleeding from brain lesion (s)\n* Radiosensitizing systemic disease (Neurofibromatosis ...)\n* Thrombocytopenia less than 100,000 cells \u002F mm3\n* Anticoagulant treatment, and \u002F 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.\n* Hemorrhagic metastasis (s) of the brainstem\n* Planning of the treatment on the target metastasis delivering a dose\\> 5 Gy on other metastases concomitant\n* Patient with prior cerebral stereotactic irradiation\n* History of total brain irradiation\n* Any associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study\n* Participation in a therapeutic trial that could compromise the conduct of study\n* Patient deprived of liberty or under guardianship","ALL","18 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases",[27],"Hemorrhagic Brain Metastases",[29,30,31,32],"hemorrhagic","brain metastases","FSRT","Stereotactic radiation therapy","RECRUITING","2025-02-07",{"date":36,"type":37},"2025-02-11","ACTUAL",{"date":39,"type":37},"2019-01-16",{"date":41,"type":21},"2028-01",{"name":43,"class":44},"Centre Francois Baclesse","OTHER",4]