[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100339221":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":29,"responsibleParty":79,"collaborators":81,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":19,"enrollmentInfo":97,"targetDuration":19,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Centre Francois Baclesse","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"FSRT Stereotactic radiation therapy","EXPERIMENTAL","Each cerebral metastasis (hemorrhagic or otherwise) will be treated by radiation",[13],"Radiation: FSRT Stereotactic radiation therapy",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"RADIATION","For each metastasis, dose of 30 Gy in 3 fractions at 10 Gy \u002F fraction over 7 days",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Julien GEFRELOT, MD","CONTACT","0231455020","j.geffrelot@baclesse.unicancer.fr",{"name":27,"role":23,"phone":24,"phoneExt":19,"email":28},"Dinu STEFAN, MD","d.stefan@baclesse.unicancer.fr",[30,45,56,68],{"facility":31,"status":32,"city":33,"state":19,"zip":19,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Centre de la Baie","RECRUITING","Avranches","France","FR",{"type":37,"coordinates":38},"Point",[39,40],-1.35686,48.68436,{"lat":40,"lon":39},[43],{"name":44,"role":23,"phone":19,"phoneExt":19,"email":19},"Victor PERNIN, MD",{"facility":46,"status":32,"city":47,"state":19,"zip":19,"country":34,"countryCode":35,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"Centre François Baclesse","Caen",{"type":37,"coordinates":49},[50,51],-0.35912,49.18585,{"lat":51,"lon":50},[54],{"name":55,"role":23,"phone":19,"phoneExt":19,"email":19},"Julien GEFFRELOT, MD",{"facility":57,"status":32,"city":58,"state":19,"zip":19,"country":34,"countryCode":35,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Hospices Civils de Lyon","Lyon",{"type":37,"coordinates":60},[61,62],4.84789,45.74906,{"lat":62,"lon":61},[65],{"name":66,"role":23,"phone":19,"phoneExt":19,"email":67},"Loïc FEUVRET","loic.feuvret@chu-lyon.fr",{"facility":69,"status":32,"city":70,"state":19,"zip":19,"country":34,"countryCode":35,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Institut de Cancérologie de Lorraine","Nancy",{"type":37,"coordinates":72},[73,74],6.18496,48.68439,{"lat":74,"lon":73},[77],{"name":78,"role":23,"phone":19,"phoneExt":19,"email":19},"Selima SELLAMI, MD",{"type":80,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[82,85],{"name":83,"class":84},"ANOCEF\u002FIGCNO","UNKNOWN",{"name":86,"class":6},"Groupement Interrégional de Recherche Clinique et d'Innovation","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":98,"type":99},46,"ESTIMATED","INTERVENTIONAL",[102],"PHASE2","This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases",[105],"Hemorrhagic Brain Metastases",[107,108,109,110],"hemorrhagic","brain metastases","FSRT","Stereotactic radiation therapy","2025-02-07",{"date":113,"type":114},"2025-02-11","ACTUAL",{"date":116,"type":114},"2019-01-16",{"date":118,"type":99},"2028-01",{"name":5,"class":6},4]