[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100339221":3},{"organization":4,"outcomesModule":7,"designInfo":15,"detailedDescription":11,"studyPopulation":11,"armGroups":21,"interventions":28,"overallOfficials":11,"centralContacts":33,"locations":42,"responsibleParty":92,"collaborators":94,"id":100,"slug":11,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":11,"enrollmentInfo":109,"targetDuration":11,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Centre Francois Baclesse","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage)",null,"6 months after end of Stereotactic radiation therapy",{"measure":14,"description":11,"timeFrame":12},"Local tumoral response rate defined according to the recommendations of the RECIST criteria",{"allocation":16,"interventionModel":17,"interventionModelDescription":11,"primaryPurpose":18,"observationalModel":11,"timePerspective":11,"maskingInfo":19},"NA","SINGLE_GROUP","TREATMENT",{"masking":20,"maskingDescription":11,"whoMasked":11},"NONE",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"FSRT Stereotactic radiation therapy","EXPERIMENTAL","Each cerebral metastasis (hemorrhagic or otherwise) will be treated by radiation",[27],"Radiation: FSRT Stereotactic radiation therapy",[29],{"type":30,"name":23,"description":31,"armGroupLabels":32,"otherNames":11},"RADIATION","For each metastasis, dose of 30 Gy in 3 fractions at 10 Gy \u002F fraction over 7 days",[23],[34,39],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Julien GEFRELOT, MD","CONTACT","0231455020","j.geffrelot@baclesse.unicancer.fr",{"name":40,"role":36,"phone":37,"phoneExt":11,"email":41},"Dinu STEFAN, MD","d.stefan@baclesse.unicancer.fr",[43,58,69,81],{"facility":44,"status":45,"city":46,"state":11,"zip":11,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Centre de la Baie","RECRUITING","Avranches","France","FR",{"type":50,"coordinates":51},"Point",[52,53],-1.35686,48.68436,{"lat":53,"lon":52},[56],{"name":57,"role":36,"phone":11,"phoneExt":11,"email":11},"Victor PERNIN, MD",{"facility":59,"status":45,"city":60,"state":11,"zip":11,"country":47,"countryCode":48,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Centre François Baclesse","Caen",{"type":50,"coordinates":62},[63,64],-0.35912,49.18585,{"lat":64,"lon":63},[67],{"name":68,"role":36,"phone":11,"phoneExt":11,"email":11},"Julien GEFFRELOT, MD",{"facility":70,"status":45,"city":71,"state":11,"zip":11,"country":47,"countryCode":48,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Hospices Civils de Lyon","Lyon",{"type":50,"coordinates":73},[74,75],4.84789,45.74906,{"lat":75,"lon":74},[78],{"name":79,"role":36,"phone":11,"phoneExt":11,"email":80},"Loïc FEUVRET","loic.feuvret@chu-lyon.fr",{"facility":82,"status":45,"city":83,"state":11,"zip":11,"country":47,"countryCode":48,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Institut de Cancérologie de Lorraine","Nancy",{"type":50,"coordinates":85},[86,87],6.18496,48.68439,{"lat":87,"lon":86},[90],{"name":91,"role":36,"phone":11,"phoneExt":11,"email":11},"Selima SELLAMI, MD",{"type":93,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[95,98],{"name":96,"class":97},"ANOCEF\u002FIGCNO","UNKNOWN",{"name":99,"class":6},"Groupement Interrégional de Recherche Clinique et d'Innovation","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":110,"type":111},46,"ESTIMATED","INTERVENTIONAL",[114],"PHASE2","This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases",[117],"Hemorrhagic Brain Metastases",[119,120,121,122],"hemorrhagic","brain metastases","FSRT","Stereotactic radiation therapy","2025-02-07",{"date":125,"type":126},"2025-02-11","ACTUAL",{"date":128,"type":126},"2019-01-16",{"date":130,"type":111},"2028-01",{"name":5,"class":6},4]