[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100253804":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":65,"centralContacts":70,"locations":79,"responsibleParty":518,"collaborators":520,"id":534,"slug":535,"hasResults":536,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":536,"sex":542,"minAge":543,"maxAge":544,"enrollmentInfo":545,"targetDuration":96,"studyType":548,"phases":549,"briefSummary":551,"conditions":552,"keywords":554,"overallStatus":82,"whyStopped":96,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":566},{"fullName":5,"class":6},"University of Sydney","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Arm - Standard BEP","ACTIVE_COMPARATOR","Participants 16 years or older will receive 4 cycles of Standard BEP as follows:\n\n* Bleomycin 30,000 IU IV weekly for 3 doses\n* Etoposide 100 mg\u002Fm2 IV on day 1 - 5\n* Cisplatin 20 mg\u002Fm2 IV on day 1 - 5\n* Pegylated G-CSF 6 mg SCI on day 6\n\nPatients \\\u003C 16 years old and weighs ≥ 45 kg will receive:\n\n* Bleomycin \\*15,000 - 30,000 IU IV weekly for 3 doses\n* Etoposide 100 mg\u002Fm2 IV on day 1 - 5\n* Cisplatin 20 mg\u002Fm2 IV on day 1 - 5\n* Pegylated G-CSF 6 mg SCI on day 6\n\nPatients \\\u003C16 years old and weighs \\\u003C 45 kg will receive:\n\n* Bleomycin \\*15,000 - 30,000 IU IV weekly for 3 doses\n* Etoposide 100 mg\u002Fm2 IV on day 1 - 5\n* Cisplatin 20 mg\u002Fm2 IV on day 1 - 5\n* Filgrastim 10mcg\u002Fkg\u002Fday on day 6, until post-nadir Absolute Neutrophil Count ≥1 x10\\^9\u002F L\n\n  * The dose of bleomycin is decided by the treating physician and based on the patient's Body Surface Area.\n\nEach cycle is 3 weeks (21 days).\n\nThe planned total duration of treatment is 12 weeks.",[13,14,15,16,17],"Drug: Bleomycin (active name: Bleomycin Sulfate)","Drug: Etoposide","Drug: Cisplatin","Drug: Pegylated G-CSF (Pegfilgrastim)","Drug: Filgrastim",{"label":19,"type":20,"description":21,"interventionNames":22},"Experimental Arm - Accelerated BEP","EXPERIMENTAL","Participants 16years or older will receive 4 cycles of Accelerated BEP as follows:\n\n* Bleomycin 30,000 IU IV wkly for 2 doses\n* Etoposide 100 mg\u002Fm2 IV on day 1 - 5\n* Cisplatin 20 mg\u002Fm2 IV on day 1- 5\n* Pegylated G-CSF 6 mg SCI on day 6\n\nPatients \\\u003C16years and weighs ≥45 kg will receive:\n\n* Bleomycin \\*15,000 - 30,000 IU IV wkly for 2 doses\n* Etoposide 100 mg\u002Fm2 IV on day 1 - 5\n* Cisplatin 20 mg\u002Fm2 IV on day 1 - 5\n* Pegylated G-CSF 6 mg SCI on day 6\n\nPatients \\\u003C16years and weighs \\\u003C45 kg will receive:\n\n* Bleomycin \\*15,000 - 30,000 IU IV wkly for 2 doses\n* Etoposide 100 mg\u002Fm2 IV on day 1 - 5\n* Cisplatin 20 mg\u002Fm2 IV on day 1 - 5\n* Filgrastim 10mcg\u002Fkg\u002Fday on day 6, until ANC ≥1 x10\\^9\u002F L\n\nEach cycle is 2 weeks (14days)\n\nFollowing 4xBEP cycles, patients will receive additional bleomycin as follows:\n\n\\- Bleomycin \\*15,000 - 30,000 IU IV wkly for 4 doses\n\n\\* The dose of bleomycin is decided by the treating physician and based on the patient's BSA.\n\nThe planned total duration is 12 weeks.",[13,14,15,16,17],[24,33,42,50,56],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Bleomycin (active name: Bleomycin Sulfate)","Standard Arm: Bleomycin 30,000 international units IV weekly for 3 doses (eg. days 1, 8 and 15 or days 2, 9 and 16 of a 21-day cycle) for 4 cycles.\n\nAccelerated Arm: Bleomycin 30,000 international units IV weekly for 2 doses (eg. days 1 and 8 or days 2 and 9 of a 14-day cycle) for 4 cycles. Followed by Bleomycin 30,000 international units IV weekly for 4 doses.",[19,9],[30,31,32],"Blenamax (Aspen)","DBL Bleomycin Sulphate (Willow Pharmaceuticals Pty Limited)","Bleo Powder for injection (Hospira)",{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Etoposide","Standard Arm: Etoposide 100 mg\u002Fm2 IV on days 1, 2, 3, 4, 5 of a 21-day cycle for 4 cycles.\n\nAccelerated Arm: 100 mg\u002Fm2 IV on days 1, 2, 3, 4, 5 of a 14-day cycle for 4 cycles.",[19,9],[38,39,40,41],"DBL Etoposide Injection (Hospira)","Etopophos (Bristol-Myers Squibb)","Etoposide (Pfizer)","Etoposide Ebewe (Sandoz)",{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Cisplatin","Standard Arm: Cisplatin 20 mg\u002Fm2 IV on days 1, 2, 3, 4, 5 of a 21-day cycle for 4 cycles.\n\nAccelerated Arm: Cisplatin 20 mg\u002Fm2 IV on days 1, 2, 3, 4, 5 of a 14-day cycle for 4 cycles.",[19,9],[47,48,49],"Cisplatin Ebewe (Sandoz)","Cisplatin injection (Pfizer)","DBL Cisplatin Injection (Hospira)",{"type":25,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Pegylated G-CSF (Pegfilgrastim)","Standard Arm: 6 mg SCI on day 6 of a 21-day cycle for 4 cycles. Accelerated Arm: 6 mg SCI on day 6 of a 14-day cycle for 4 cycles.",[19,9],[55],"Neulasta Syringe with Automatic Needle Guard (Amgen)",{"type":25,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"Filgrastim","Standard Arm: 10 mcg\u002Fkg\u002Fday on day6, until post-nadir absolute neutrophil count ≥ 1.0 x 10\\^9\u002FL, of a 21-day cycle for 4 cycles.\n\nAccelerated Arm: 10 mcg\u002Fkg\u002Fday on day 6, until post-nadir absolute neutrophil count ≥ 1.0 x 10\\^9\u002FL, of a 14-day cycle for 4 cycles.",[19,9],[61,62,63,64],"Neupogen (Amgen)","Nivestim (Hospira)","Tevagrastim (Teva Pharma Australia Pty Ltd)","Zarzio (Sandoz)",[66],{"name":67,"affiliation":68,"role":69},"Peter Grimison","Chris O'Brien Lifehouse","STUDY_CHAIR",[71,77],{"name":72,"role":73,"phone":74,"phoneExt":75,"email":76},"P3BEP Trial Coordinator","CONTACT","+6195625000","5000","p3bep@ctc.usyd.edu.au",{"name":78,"role":73,"phone":74,"phoneExt":75,"email":76},"P3BEP Project Manager",[80,101,121,138,156,168,183,197,204,218,235,252,270,284,301,319,329,347,365,382,399,408,425,443,460,474,492,509],{"facility":81,"status":82,"city":83,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Memorial Sloan Kettering Cancer Centre","RECRUITING","New York","10065","United States","US",{"type":88,"coordinates":89},"Point",[90,91],-74.00597,40.71427,{"lat":91,"lon":90},[94,98],{"name":95,"role":73,"phone":96,"phoneExt":96,"email":97},"Victoria Martorana",null,"martorav@mskcc.org",{"name":99,"role":100,"phone":96,"phoneExt":96,"email":96},"Darren Feldman","PRINCIPAL_INVESTIGATOR",{"facility":102,"status":82,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Calvary Mater Newcastle","Newcastle","New South Wales","2298","Australia","AU",{"type":88,"coordinates":109},[110,111],151.7801,-32.92953,{"lat":111,"lon":110},[114,117,120],{"name":115,"role":73,"phone":96,"phoneExt":96,"email":116},"Louise Plowman","Louise.Plowman@calvarymater.org.au",{"name":118,"role":73,"phone":96,"phoneExt":96,"email":119},"Girish Mallesara","girish.mallesara@calvarymater.org.au",{"name":118,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":122,"status":82,"city":123,"state":104,"zip":124,"country":106,"countryCode":107,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Royal North Shore Hospital","St Leonards","2065",{"type":88,"coordinates":126},[127,128],151.19836,-33.82344,{"lat":128,"lon":127},[131,134,137],{"name":132,"role":73,"phone":96,"phoneExt":96,"email":133},"Susan Kirby-Lewis","Susan.KirbyLewis@health.nsw.gov.au",{"name":135,"role":73,"phone":96,"phoneExt":96,"email":136},"Alexander Guminski","aguminski@nsccahs.health.nsw.gov.au",{"name":135,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":139,"status":82,"city":140,"state":104,"zip":141,"country":106,"countryCode":107,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Prince of Wales Hospital","Sydney","2031",{"type":88,"coordinates":143},[144,145],151.20732,-33.86785,{"lat":145,"lon":144},[148,151,154],{"name":149,"role":73,"phone":96,"phoneExt":96,"email":150},"Daisy Buchanan","Daisy.buchanan@sesiahs.health.nsw.gov.au",{"name":152,"role":73,"phone":96,"phoneExt":96,"email":153},"Julie Howard","Julie.howard@sesiahs.health.nsw.gov.au",{"name":155,"role":100,"phone":96,"phoneExt":96,"email":96},"Elizabeth Hovey",{"facility":68,"status":82,"city":140,"state":104,"zip":157,"country":106,"countryCode":107,"cosmosGeoPoint":158,"geoPoint":160,"contacts":161},"2050",{"type":88,"coordinates":159},[144,145],{"lat":145,"lon":144},[162,165,167],{"name":163,"role":73,"phone":96,"phoneExt":96,"email":164},"Melissa Quaggiott","melissa.mcmahon@lh.org.au",{"name":67,"role":73,"phone":96,"phoneExt":96,"email":166},"peter.grimison@lh.org.au",{"name":67,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":169,"status":82,"city":140,"state":104,"zip":170,"country":106,"countryCode":107,"cosmosGeoPoint":171,"geoPoint":173,"contacts":174},"Macquarie Cancer Clinical Trials","2109",{"type":88,"coordinates":172},[144,145],{"lat":145,"lon":144},[175,178,181],{"name":176,"role":73,"phone":96,"phoneExt":96,"email":177},"Louise Francisco","louise.francisco@mq.edu.au",{"name":179,"role":73,"phone":96,"phoneExt":96,"email":180},"Radhika Butala","radhika.butala@mq.edu.au",{"name":182,"role":100,"phone":96,"phoneExt":96,"email":96},"Howard Gurney",{"facility":184,"status":82,"city":140,"state":104,"zip":185,"country":106,"countryCode":107,"cosmosGeoPoint":186,"geoPoint":188,"contacts":189},"Concord Repatriation General Hospital","2139",{"type":88,"coordinates":187},[144,145],{"lat":145,"lon":144},[190,193,196],{"name":191,"role":73,"phone":96,"phoneExt":96,"email":192},"Kathy Hall","Kathy.Hall@sswahs.nsw.gov.au",{"name":194,"role":73,"phone":96,"phoneExt":96,"email":195},"Martin Stockler","martin.stockler@sydney.edu.au",{"name":194,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":198,"status":199,"city":140,"state":104,"zip":200,"country":106,"countryCode":107,"cosmosGeoPoint":201,"geoPoint":203,"contacts":96},"Westmead Hospital","WITHDRAWN","2145",{"type":88,"coordinates":202},[144,145],{"lat":145,"lon":144},{"facility":205,"status":82,"city":140,"state":104,"zip":206,"country":106,"countryCode":107,"cosmosGeoPoint":207,"geoPoint":209,"contacts":210},"Nepean Hospital","2751",{"type":88,"coordinates":208},[144,145],{"lat":145,"lon":144},[211,214,217],{"name":212,"role":73,"phone":96,"phoneExt":96,"email":213},"Jeremy Jones","jeremy.jones@swahs.health.nsw.gov.au",{"name":215,"role":73,"phone":96,"phoneExt":96,"email":216},"Amanda Stevanovic","amanda.stevanovic@swahs.health.nsw.gov.au",{"name":215,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":219,"status":82,"city":220,"state":104,"zip":221,"country":106,"countryCode":107,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Tweed Hospital","Tweed Heads","2485",{"type":88,"coordinates":223},[224,225],153.5452,-28.17671,{"lat":225,"lon":224},[228,231,234],{"name":229,"role":73,"phone":96,"phoneExt":96,"email":230},"Charmayne Chorlton","Charmayne.Chorlton@ncahs.health.nsw.gov.au",{"name":232,"role":73,"phone":96,"phoneExt":96,"email":233},"Ratnesh Srivastav","Ratnesh Srivastav \u003Cratnesh.srivastav@health.nsw.gov.au>",{"name":232,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":236,"status":82,"city":237,"state":104,"zip":238,"country":106,"countryCode":107,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"SAN Clinical Trials Unit","Wahroonga","2076",{"type":88,"coordinates":240},[241,242],151.11561,-33.71816,{"lat":242,"lon":241},[245,248,251],{"name":246,"role":73,"phone":96,"phoneExt":96,"email":247},"James McQuilan","James.McQuillan@sah.org.au",{"name":249,"role":73,"phone":96,"phoneExt":96,"email":250},"Gavin Marx","gmarx@nhog.com.au",{"name":249,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":253,"status":82,"city":254,"state":255,"zip":256,"country":106,"countryCode":107,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"Royal Brisbane & Women's Hospital","Brisbane","Queensland","4029",{"type":88,"coordinates":258},[259,260],153.02809,-27.46794,{"lat":260,"lon":259},[263,266,269],{"name":264,"role":73,"phone":96,"phoneExt":96,"email":265},"Natasha Roberts","natasha.roberts@health.qld.gov.au",{"name":267,"role":73,"phone":96,"phoneExt":96,"email":268},"David Wyld","david.wyld@health.qld.gov.au",{"name":267,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":271,"status":82,"city":272,"state":255,"zip":273,"country":106,"countryCode":107,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"Queensland Children's Hospital","South Brisbane","4101",{"type":88,"coordinates":275},[276,277],153.02049,-27.48034,{"lat":277,"lon":276},[280,283],{"name":281,"role":73,"phone":96,"phoneExt":96,"email":282},"Rick Walker","'Rick.Walker@health.qld.gov.au'",{"name":281,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":285,"status":82,"city":286,"state":255,"zip":287,"country":106,"countryCode":107,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"Princess Alexandra","Woolloongabba","4102",{"type":88,"coordinates":289},[290,291],153.03655,-27.48855,{"lat":291,"lon":290},[294,297,300],{"name":295,"role":73,"phone":96,"phoneExt":96,"email":296},"Paul Baxter","Paul.Baxter@health.qld.gov.au",{"name":298,"role":73,"phone":96,"phoneExt":96,"email":299},"Euan Walpole","Euan.Walpole@health.qld.gov.au",{"name":298,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":302,"status":82,"city":303,"state":304,"zip":75,"country":106,"countryCode":107,"cosmosGeoPoint":305,"geoPoint":309,"contacts":310},"Royal Adelaide Hospital","Adelaide","South Australia",{"type":88,"coordinates":306},[307,308],138.59863,-34.92866,{"lat":308,"lon":307},[311,314,317],{"name":312,"role":73,"phone":96,"phoneExt":96,"email":313},"Hazel Bourke","hazel.bourke@health.sa.gov.au",{"name":315,"role":73,"phone":96,"phoneExt":96,"email":316},"Thean Hsiang Tan","hsiang.tan@health.sa.gov.au",{"name":318,"role":100,"phone":96,"phoneExt":96,"email":96},"Thean Tan",{"facility":320,"status":321,"city":322,"state":304,"zip":323,"country":106,"countryCode":107,"cosmosGeoPoint":324,"geoPoint":328,"contacts":96},"Flinders Medical Centre","ACTIVE_NOT_RECRUITING","Bedford Park","5042",{"type":88,"coordinates":325},[326,327],138.56815,-35.02204,{"lat":327,"lon":326},{"facility":330,"status":82,"city":331,"state":332,"zip":333,"country":106,"countryCode":107,"cosmosGeoPoint":334,"geoPoint":338,"contacts":339},"Royal Hobart Hospital","Hobart","Tasmania","7000",{"type":88,"coordinates":335},[336,337],147.32941,-42.87936,{"lat":337,"lon":336},[340,343,346],{"name":341,"role":73,"phone":96,"phoneExt":96,"email":342},"Lesley Oliver","lesley.oliver@dhhs.tas.gov.au",{"name":344,"role":73,"phone":96,"phoneExt":96,"email":345},"Rebecca Tay","rebecca.tay@ths.tas.gov.au",{"name":344,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":348,"status":82,"city":349,"state":350,"zip":351,"country":106,"countryCode":107,"cosmosGeoPoint":352,"geoPoint":356,"contacts":357},"Box Hill Hospital","Box Hill","Victoria","3128",{"type":88,"coordinates":353},[354,355],145.12545,-37.81887,{"lat":355,"lon":354},[358,361,364],{"name":359,"role":73,"phone":96,"phoneExt":96,"email":360},"Lauren Mitchell","lauren.mitchell@monash.edu",{"name":362,"role":73,"phone":96,"phoneExt":96,"email":363},"Ian Davis","Ian.Davis@monash.edu",{"name":362,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":366,"status":82,"city":367,"state":350,"zip":368,"country":106,"countryCode":107,"cosmosGeoPoint":369,"geoPoint":373,"contacts":374},"Peter MacCallum Cancer Centre","East Melbourne","3002",{"type":88,"coordinates":370},[371,372],144.9879,-37.81667,{"lat":372,"lon":371},[375,378,381],{"name":376,"role":73,"phone":96,"phoneExt":96,"email":377},"Jennifer Petersen","jennifer.petersen@petermac.org",{"name":379,"role":73,"phone":96,"phoneExt":96,"email":380},"Ben Tran","ben.tran@petermac.org",{"name":379,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":383,"status":82,"city":384,"state":350,"zip":385,"country":106,"countryCode":107,"cosmosGeoPoint":386,"geoPoint":390,"contacts":391},"Austin Health","Heidelberg","3084",{"type":88,"coordinates":387},[388,389],145.06667,-37.75,{"lat":389,"lon":388},[392,395,398],{"name":393,"role":73,"phone":96,"phoneExt":96,"email":394},"Jaren Caine","Jaren.Caine@austin.org.au",{"name":396,"role":73,"phone":96,"phoneExt":96,"email":397},"Andrew Weickhardt","Andrew.Weickhardt@ludwig.edu.au",{"name":396,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":400,"status":199,"city":401,"state":350,"zip":402,"country":106,"countryCode":107,"cosmosGeoPoint":403,"geoPoint":407,"contacts":96},"Sunshine Hospital","St Albans","3021",{"type":88,"coordinates":404},[405,406],144.80049,-37.74496,{"lat":406,"lon":405},{"facility":409,"status":82,"city":410,"state":350,"zip":411,"country":106,"countryCode":107,"cosmosGeoPoint":412,"geoPoint":416,"contacts":417},"Border Medical Oncology","Wodonga","3690",{"type":88,"coordinates":413},[414,415],146.88809,-36.12179,{"lat":415,"lon":414},[418,421,424],{"name":419,"role":73,"phone":96,"phoneExt":96,"email":420},"Lauren Callow","lcallow@bordermedonc.com.au",{"name":422,"role":73,"phone":96,"phoneExt":96,"email":423},"Craig Underhill","cunderhill@bordermedonc.com.au",{"name":422,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":426,"status":82,"city":427,"state":428,"zip":429,"country":106,"countryCode":107,"cosmosGeoPoint":430,"geoPoint":434,"contacts":435},"Fiona Stanley Hospital","Murdoch","Western Australia","6847",{"type":88,"coordinates":431},[432,433],115.83757,-32.06987,{"lat":433,"lon":432},[436,439,442],{"name":437,"role":73,"phone":96,"phoneExt":96,"email":438},"Jaye Harding","jaye.harding@health.wa.gov.au",{"name":440,"role":73,"phone":96,"phoneExt":96,"email":441},"Simon Troon","simon.troon@health.wa.gov.au",{"name":440,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":444,"status":82,"city":445,"state":446,"zip":447,"country":448,"countryCode":449,"cosmosGeoPoint":450,"geoPoint":454,"contacts":455},"Starship Children's Hospital","Grafton","Auckland","1023","New Zealand","NZ",{"type":88,"coordinates":451},[452,453],174.76566,-36.86029,{"lat":453,"lon":452},[456,459],{"name":457,"role":73,"phone":96,"phoneExt":96,"email":458},"Mark Winstanley","'mwinstanley@adhb.govt.nz'",{"name":457,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":461,"status":82,"city":445,"state":446,"zip":462,"country":448,"countryCode":449,"cosmosGeoPoint":463,"geoPoint":465,"contacts":466},"Auckland Hospital","1142",{"type":88,"coordinates":464},[452,453],{"lat":453,"lon":452},[467,470,473],{"name":468,"role":73,"phone":96,"phoneExt":96,"email":469},"Andrew Conley","andrewcon@adhb.govt.nz",{"name":471,"role":73,"phone":96,"phoneExt":96,"email":472},"Fritha Hanning","FrithaH@adhb.govt.nz",{"name":471,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":475,"status":82,"city":476,"state":477,"zip":478,"country":448,"countryCode":449,"cosmosGeoPoint":479,"geoPoint":483,"contacts":484},"Palmerston North Hospital","Roslyn","Palmerston North","4442",{"type":88,"coordinates":480},[481,482],170.48333,-45.86667,{"lat":482,"lon":481},[485,488,491],{"name":486,"role":73,"phone":96,"phoneExt":96,"email":487},"Sarah Holwell","Sarah.Holwell@midcentraldhb.govt.nz",{"name":489,"role":73,"phone":96,"phoneExt":96,"email":490},"Gary Forgeson","Garry.Forgeson@midcentraldhb.govt.nz",{"name":489,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":493,"status":82,"city":494,"state":96,"zip":495,"country":448,"countryCode":449,"cosmosGeoPoint":496,"geoPoint":500,"contacts":501},"Christchurch Hospital","Christchurch","8011",{"type":88,"coordinates":497},[498,499],172.63333,-43.53333,{"lat":499,"lon":498},[502,505,508],{"name":503,"role":73,"phone":96,"phoneExt":96,"email":504},"Elizabeth Thompson","liz.thompson@cdhb.health.nz",{"name":506,"role":73,"phone":96,"phoneExt":96,"email":507},"Mark Jeffrey","Mark.jeffery@cdhb.health.nz",{"name":506,"role":100,"phone":96,"phoneExt":96,"email":96},{"facility":510,"status":199,"city":511,"state":96,"zip":512,"country":448,"countryCode":449,"cosmosGeoPoint":513,"geoPoint":517,"contacts":96},"Dunedin Hospital","Dunedin","9054",{"type":88,"coordinates":514},[515,516],170.50361,-45.87416,{"lat":516,"lon":515},{"type":519,"investigatorFullName":96,"investigatorTitle":96,"investigatorAffiliation":96,"oldNameTitle":96,"oldOrganization":96},"SPONSOR",[521,523,525,528,530,532],{"name":522,"class":6},"Australian and New Zealand Urogenital and Prostate Cancer Trials Group",{"name":524,"class":6},"Cambridge University Hospitals NHS Foundation Trust",{"name":526,"class":527},"Cancer Trials Ireland","NETWORK",{"name":529,"class":527},"Children's Oncology Group",{"name":531,"class":6},"Dana-Farber Cancer Institute",{"name":533,"class":6},"University of Southern California","100253804","phase-3-accelerated-vs-standard-bep-chemotherapy-for-patients-with-intermediate-and-poor-risk-metastatic-germ-cell-tumours-100253804",false,"NCT02582697","Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours","Phase 3 Accelerated BEP: A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours","P3BEP","Inclusion Criteria:\n\n1. Age ≥ 11 years and ≤ 50 years on the date of randomisation\n2. Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or Exceptionally raised tumour markers (AFP ≥ 1000ng\u002FmL and\u002For HCG ≥ 5000 IU\u002FL) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently\n3. Primary arising in testis, ovary, retro-peritoneum, or mediastinum\n4. Metastatic disease or non-testicular primary\n5. Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries). (See protocol for more information).\n6. Adequate bone marrow function with ANC ≥1.0 x 10\\^9\u002FL, Platelet count ≥100 x 10\\^9\u002FL\n7. Adequate liver function where bilirubin must be ≤1.5 x ULN, except participants with Gilbert's Syndrome where bilirubin must be ≤2.0 x ULN; ALT and AST must be ≤2.5 x ULN, except if the elevations are due to hepatic metastases, in which case ALT and AST must be ≤ 5 x ULN\n8. Adequate renal function with estimated creatinine clearance of ≥60 ml\u002Fmin according to the Cockcroft-Gault formula, unless calculated to be \\\u003C 60 ml\u002Fmin or borderline in which case GFR should be formally measured, eg. with EDTA scan\n9. ECOG Performance Status of 0, 1, 2, or 3\n10. Study treatment both planned and able to start within 14 days of randomisation.\n11. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments\n12. Able to provide signed, written informed consent\n\nExclusion Criteria:\n\n1. Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)\n2. Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin or if patient hasb. non-seminoma by IGCCC criteria or stage IV malignant ovarian germ cell tumour in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (eg. organ failure, vena cava obstruction, overwhelming burden of disease). Acceptable regimens include cisplatin 20 mg\u002Fm2 days 1-2 and etoposide 100 mg\u002Fm2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg\u002Fm2 days 1-2; or baby-BOP.43 Patients must meet all other inclusion and exclusion criteria at the time of registration.\n\n   Additionally participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomisation. Such patients must be discussed with the coordinating centre prior to registration, and must be registered within 10 days of commencing study chemotherapy.\n3. Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin\n4. Significant co-morbid respiratory disease that contraindicates the use of bleomycin\n5. Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus\n6. Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety\n7. Inadequate contraception. Men must use 2 effective methods of contraception, including use of a condom, during chemotherapy and for a year after completing chemotherapy.\n8. Known allergy or hypersensitivity to any of the study drugs\n9. Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse\n\nThe above inclusion and exclusion criteria will apply to stage 1 (n=150) and stage 2 (n=500 including stage 1) of the study. All sites will participate in both stages of the study with the exception of the Children's Oncology Group who will be participate in stage 1 only.","ALL","11 Years","50 Years",{"count":546,"type":547},500,"ESTIMATED","INTERVENTIONAL",[550],"PHASE3","The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.",[553],"Germ Cell Tumor",[555,556],"Germ Cell","Intermediate and poor-risk metastatic germ cell tumours","2025-06-11",{"date":559,"type":560},"2025-06-15","ACTUAL",{"date":562,"type":560},"2014-02",{"date":564,"type":547},"2029-12-31",{"name":5,"class":6},28]