[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443172":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":124,"collaborators":126,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":132,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":25,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"British Columbia Cancer Agency","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"20 Gy in 5 Fractions Volumetric Modulated Arc Therapy to Brain Metastases","ACTIVE_COMPARATOR","Five treatments of 4 Gy will be delivered using volumetric modulated arc therapy on a conventional linear accelerator in a conventional head shell without the use of stereotactic radiosurgery technique.",[13],"Radiation: Targeting All Brain Metastases",{"label":15,"type":16,"description":17,"interventionNames":18},"8 Gy in 1 Fraction Volumetric Modulated Arc Therapy to Brain Metastases","EXPERIMENTAL","A single treatment of 8 Gy will be delivered using volumetric modulated arc therapy on a conventional linear accelerator in a conventional head shell without the use of stereotactic radiosurgery technique.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Targeting All Brain Metastases","Volumetric Modulated Arc Therapy",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Alan Nichol, MD","BC Cancer Vancouver","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Sandy Chang","CONTACT","604-877-6000","2683","sandy.chang@bccancer.bc.ca",[39,56,70,84,96,111],{"facility":40,"status":41,"city":42,"state":43,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"BC Cancer - Abbotsford","RECRUITING","Abbotsford British Columbia","British Columbia","Canada","CA",{"type":47,"coordinates":48},"Point",[49,50],-122.25257,49.05798,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":25,"email":25},"Fred Hsu, BSc MD FRCPC","6048514710",{"facility":57,"status":41,"city":58,"state":43,"zip":59,"country":44,"countryCode":45,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"BC Cancer - Kelowna","Kelowna","V1Y5L3",{"type":47,"coordinates":61},[62,63],-119.48568,49.88307,{"lat":63,"lon":62},[66],{"name":67,"role":34,"phone":68,"phoneExt":25,"email":69},"Benjamin Mou, MD FRCPC DABR","250-712-3900","Benjamin.Mou@bccancer.bc.ca",{"facility":71,"status":41,"city":72,"state":43,"zip":73,"country":44,"countryCode":45,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"BC Cancer - Prince George","Prince George","V2M7E9",{"type":47,"coordinates":75},[76,77],-122.75301,53.9166,{"lat":77,"lon":76},[80],{"name":81,"role":34,"phone":82,"phoneExt":25,"email":83},"Robert Olson, MD MSc FRCPC","25064573000","rolson2@bccancer.bc.ca",{"facility":85,"status":41,"city":86,"state":43,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"BC Cancer - Surrey","Surrey",{"type":47,"coordinates":88},[89,90],-122.82509,49.10635,{"lat":90,"lon":89},[93],{"name":94,"role":34,"phone":95,"phoneExt":25,"email":25},"Sarah Baker, MD","604.930.2098",{"facility":97,"status":41,"city":98,"state":43,"zip":99,"country":44,"countryCode":45,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"BC Cancer - Vancouver","Vancouver","V5Z 4E6",{"type":47,"coordinates":101},[102,103],-123.11934,49.24966,{"lat":103,"lon":102},[106,109],{"name":33,"role":34,"phone":107,"phoneExt":108,"email":37},"604-675-4100","202199",{"name":110,"role":30,"phone":25,"phoneExt":25,"email":25},"Shilo Lefresne, MD",{"facility":112,"status":41,"city":113,"state":43,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"BC Cancer - Victoria","Victoria",{"type":47,"coordinates":115},[116,117],-123.35155,48.4359,{"lat":117,"lon":116},[120],{"name":121,"role":34,"phone":122,"phoneExt":25,"email":123},"Isabelle Vallieres, MD MSc FRCPC","2505195577","isabelle.vallieres@bccancer.bc.ca",{"type":125,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[127],{"name":128,"class":129},"Varian Medical Systems","INDUSTRY","100443172","phase-2-rapid-simple-targeted-radiation-treatment-for-brain-metastases-100443172",false,"NCT05050929","RAPid SimPLE Targeted Radiation Treatment for Brain Metastases","Randomized Phase II Non-Inferiority Study of 5-Day Versus 1-Day RAPid SimPLE (RAPPLE) Targeted Radiation Treatment for Brain Metastases","RAPPLE","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for participation in this study:\n\n* Age ≥ 18\n* Pathological diagnosis of a non-hematopoietic malignancy\n* Brain metastases of any size\n* Any number of untreated or progressing, previously treated brain metastases that can all be contoured and targeted\n* Presence of extracranial disease\n* Diagnosis-Specific Graded Prognostic Assessment ≤ 2.0. (https:\u002F\u002Fbrainmetgpa.com\u002F) or Graded Prognostic Assessment ≤ 2.0 (Appendix I)\n* Able to complete the EuroQOL (EQ-5D-5L) questionnaire\n* Willing and able to have regular imaging follow up\n* Feasible to start protocol treatment within 14 days of participant enrolment\n* Karnofsky Performance Score (KPS) ≥ 50\n\nExclusion Criteria:\n\nSubjects are excluded from the study if any of the following criteria apply:\n\n* Inability to have a brain MRI\n* WBRT less than 3 months prior to randomization\n* Disseminated leptomeningeal carcinomatosis (limited pachymeningeal disease is permitted)\n* Multiple sclerosis\n* Neurologically declining despite corticosteroids\n* Appropriate for surgery or stereotactic radiosurgery\n* Germ cell and primary brain tumours\n* Systemic lupus erythematosis, scleroderma, or other connective tissue disorders not in remission\n* Any other serious intercurrent illness or medical condition judged by the local investigator to compromise the participant's safety, preclude safe administration of the planned protocol treatment, or prevent the participant from being managed according to the protocol guidelines\n* Pregnancy\n* Potentially fertile men or women of childbearing potential who are unwilling to employ highly effective contraception","ALL","18 Years","100 Years",{"count":142,"type":143},100,"ESTIMATED","INTERVENTIONAL",[146],"PHASE2","The aim of the study is to show that rapid, simple targeted radiotherapy to brain metastases with 8 Gy \u002F 1 is non-inferior to 20 Gy \u002F 5 in terms of overall survival for patients with poor prognosis.",[149],"Brain Metastases, Adult",[151,152,153,154,155],"radiotherapy","randomized clinical trial","phase II","non-inferiority","overall survival","2025-04-15",{"date":158,"type":159},"2025-04-17","ACTUAL",{"date":161,"type":159},"2022-07-01",{"date":163,"type":143},"2027-12-30",{"name":5,"class":6},6]