[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02582697":3,"trial-entities:NCT02582697":517,"trial-summary:NCT02582697":522},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":74,"secondary_outcomes":79,"sex":109,"minimum_age":110,"maximum_age":111,"healthy_volunteers":112,"eligibility_criteria":113,"std_ages":117,"locations":120,"central_contacts":501,"overall_officials":508,"references":511,"see_also_links":516},"NCT02582697","ANZUP1302","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","RECRUITING","2029-12-31","2025-06","2025-06-15","2014-02","University of Sydney","OTHER",true,"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.","Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). Cure rates are over 90% for good-risk disease, 85% with intermediate-risk, and about 70% for poor-risk disease. Previous strategies to improve first-line chemotherapy have failed to improve cure rates and were more toxic than BEP. New strategies are needed for patients with intermediate and poor-risk disease. BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) is conducting a trial comparing accelerated BEP with standard BEP. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.",[19],"Germ Cell Tumor",[21,22],"Germ Cell","Intermediate and poor-risk metastatic germ cell tumours","INTERVENTIONAL","TREATMENT",[26],"PHASE3",{"count":28,"type":29},500,"ESTIMATED",[31,42,51,59,65],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":38},"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.",[36,37],"Experimental Arm - Accelerated BEP","Standard Arm - Standard BEP",[39,40,41],"Blenamax (Aspen)","DBL Bleomycin Sulphate (Willow Pharmaceuticals Pty Limited)","Bleo Powder for injection (Hospira)",{"type":32,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"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.",[36,37],[47,48,49,50],"DBL Etoposide Injection (Hospira)","Etopophos (Bristol-Myers Squibb)","Etoposide (Pfizer)","Etoposide Ebewe (Sandoz)",{"type":32,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"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.",[36,37],[56,57,58],"Cisplatin Ebewe (Sandoz)","Cisplatin injection (Pfizer)","DBL Cisplatin Injection (Hospira)",{"type":32,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"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.",[36,37],[64],"Neulasta Syringe with Automatic Needle Guard (Amgen)",{"type":32,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"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.",[36,37],[70,71,72,73],"Neupogen (Amgen)","Nivestim (Hospira)","Tevagrastim (Teva Pharma Australia Pty Ltd)","Zarzio (Sandoz)",[75],{"measure":76,"description":77,"timeFrame":78},"Progression-free survival (disease progression or death)","PFS is measured from the date of randomisation until the criteria for disease progression are met (as defined in the protocol) or death. Participants who are not observed to progress nor die will be censored at the date of last follow-up","From randomisation up to disease progression or date of death whichever come first, assessed up to 5 years",[80,84,88,92,96,99,102,106],{"measure":81,"description":82,"timeFrame":83},"Initial response assessment","The assessment of response of germ cell tumours is measured by the change in size of measurable tumour masses in combination with changes in serum tumour markers after chemotherapy treatment.","At end of chemotherapy treatment, treatment planned for 12 weeks",{"measure":85,"description":86,"timeFrame":87},"Final response assessment","The assessment of response of germ cell tumours is measured by changes in serum tumour markers and imaging at 6 months from randomisation, or after any post-chemotherapy surgical resection or other intervention, whichever occurs last.","At 6 months",{"measure":89,"description":90,"timeFrame":91},"Adverse events (worst grade according to NCI CTCAE v4.03)","The intensity of adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE v4.03)","From start of chemotherapy until 30 days after last dose, an average of 4 months",{"measure":93,"description":94,"timeFrame":95},"Health-related quality of life","HR-QoL measures will include the EORTC core quality of life questionnaire (QLQ-C30), a 30-item cancer-specific questionnaire that is well-validated and available in many languages.","From date of randomisation until date of 18 month follow-up",{"measure":97,"description":98,"timeFrame":95},"Health-related quality of life for testicular cancer","EORTC quality of life module for testicular cancer (QLQ-TC26), a disease-specific measure with 26 items about physical symptoms, sexual functioning and emotional issues.",{"measure":100,"description":101,"timeFrame":95},"Treatment preference","A trial-specific preferences question will be used to determine if participants think they would prefer to be treated with accelerated BEP or standard BEP, assuming that they were equally effective.",{"measure":103,"description":104,"timeFrame":105},"Delivered dose-intensity of chemotherapy (relative to standard BEP)","Delivered dose-intensity of cisplatin, etoposide and bleomycin will be assessed.","From start date of chemotherapy treatment until date of end of chemotherapy, an average of 12 weeks",{"measure":107,"description":108,"timeFrame":78},"Overall survival","Overall survival is measured from the date of randomisation until death from any cause, or the date of last known follow-up alive.","ALL","11 Years","50 Years",false,{"inclusion":114,"exclusion":115,"raw_text":116},[],[],"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.",[118,119],"CHILD","ADULT",[121,137,154,169,185,197,210,222,227,239,254,269,285,297,312,329,337,353,369,384,399,406,421,437,451,463,479,494],{"facility":122,"status":8,"city":123,"state":123,"zip":124,"country":125,"contacts":126,"geoPoint":134},"Memorial Sloan Kettering Cancer Centre","New York","10065","United States",[127,131],{"name":128,"role":129,"email":130},"Victoria Martorana","CONTACT","martorav@mskcc.org",{"name":132,"role":133},"Darren Feldman","PRINCIPAL_INVESTIGATOR",{"lat":135,"lon":136},40.71427,-74.00597,{"facility":138,"status":8,"city":139,"state":140,"zip":141,"country":142,"contacts":143,"geoPoint":151},"Calvary Mater Newcastle","Newcastle","New South Wales","2298","Australia",[144,147,150],{"name":145,"role":129,"email":146},"Louise Plowman","Louise.Plowman@calvarymater.org.au",{"name":148,"role":129,"email":149},"Girish Mallesara","girish.mallesara@calvarymater.org.au",{"name":148,"role":133},{"lat":152,"lon":153},-32.92953,151.7801,{"facility":155,"status":8,"city":156,"state":140,"zip":157,"country":142,"contacts":158,"geoPoint":166},"Royal North Shore Hospital","St Leonards","2065",[159,162,165],{"name":160,"role":129,"email":161},"Susan Kirby-Lewis","Susan.KirbyLewis@health.nsw.gov.au",{"name":163,"role":129,"email":164},"Alexander Guminski","aguminski@nsccahs.health.nsw.gov.au",{"name":163,"role":133},{"lat":167,"lon":168},-33.82344,151.19836,{"facility":170,"status":8,"city":171,"state":140,"zip":172,"country":142,"contacts":173,"geoPoint":182},"Prince of Wales Hospital","Sydney","2031",[174,177,180],{"name":175,"role":129,"email":176},"Daisy Buchanan","Daisy.buchanan@sesiahs.health.nsw.gov.au",{"name":178,"role":129,"email":179},"Julie Howard","Julie.howard@sesiahs.health.nsw.gov.au",{"name":181,"role":133},"Elizabeth Hovey",{"lat":183,"lon":184},-33.86785,151.20732,{"facility":186,"status":8,"city":171,"state":140,"zip":187,"country":142,"contacts":188,"geoPoint":196},"Chris O'Brien Lifehouse","2050",[189,192,195],{"name":190,"role":129,"email":191},"Melissa Quaggiott","melissa.mcmahon@lh.org.au",{"name":193,"role":129,"email":194},"Peter Grimison","peter.grimison@lh.org.au",{"name":193,"role":133},{"lat":183,"lon":184},{"facility":198,"status":8,"city":171,"state":140,"zip":199,"country":142,"contacts":200,"geoPoint":209},"Macquarie Cancer Clinical Trials","2109",[201,204,207],{"name":202,"role":129,"email":203},"Louise Francisco","louise.francisco@mq.edu.au",{"name":205,"role":129,"email":206},"Radhika Butala","radhika.butala@mq.edu.au",{"name":208,"role":133},"Howard Gurney",{"lat":183,"lon":184},{"facility":211,"status":8,"city":171,"state":140,"zip":212,"country":142,"contacts":213,"geoPoint":221},"Concord Repatriation General Hospital","2139",[214,217,220],{"name":215,"role":129,"email":216},"Kathy Hall","Kathy.Hall@sswahs.nsw.gov.au",{"name":218,"role":129,"email":219},"Martin Stockler","martin.stockler@sydney.edu.au",{"name":218,"role":133},{"lat":183,"lon":184},{"facility":223,"status":224,"city":171,"state":140,"zip":225,"country":142,"geoPoint":226},"Westmead Hospital","WITHDRAWN","2145",{"lat":183,"lon":184},{"facility":228,"status":8,"city":171,"state":140,"zip":229,"country":142,"contacts":230,"geoPoint":238},"Nepean Hospital","2751",[231,234,237],{"name":232,"role":129,"email":233},"Jeremy Jones","jeremy.jones@swahs.health.nsw.gov.au",{"name":235,"role":129,"email":236},"Amanda Stevanovic","amanda.stevanovic@swahs.health.nsw.gov.au",{"name":235,"role":133},{"lat":183,"lon":184},{"facility":240,"status":8,"city":241,"state":140,"zip":242,"country":142,"contacts":243,"geoPoint":251},"Tweed Hospital","Tweed Heads","2485",[244,247,250],{"name":245,"role":129,"email":246},"Charmayne Chorlton","Charmayne.Chorlton@ncahs.health.nsw.gov.au",{"name":248,"role":129,"email":249},"Ratnesh Srivastav","Ratnesh Srivastav \u003Cratnesh.srivastav@health.nsw.gov.au>",{"name":248,"role":133},{"lat":252,"lon":253},-28.17671,153.5452,{"facility":255,"status":8,"city":256,"state":140,"zip":257,"country":142,"contacts":258,"geoPoint":266},"SAN Clinical Trials Unit","Wahroonga","2076",[259,262,265],{"name":260,"role":129,"email":261},"James McQuilan","James.McQuillan@sah.org.au",{"name":263,"role":129,"email":264},"Gavin Marx","gmarx@nhog.com.au",{"name":263,"role":133},{"lat":267,"lon":268},-33.71816,151.11561,{"facility":270,"status":8,"city":271,"state":272,"zip":273,"country":142,"contacts":274,"geoPoint":282},"Royal Brisbane & Women's Hospital","Brisbane","Queensland","4029",[275,278,281],{"name":276,"role":129,"email":277},"Natasha Roberts","natasha.roberts@health.qld.gov.au",{"name":279,"role":129,"email":280},"David Wyld","david.wyld@health.qld.gov.au",{"name":279,"role":133},{"lat":283,"lon":284},-27.46794,153.02809,{"facility":286,"status":8,"city":287,"state":272,"zip":288,"country":142,"contacts":289,"geoPoint":294},"Queensland Children's Hospital","South Brisbane","4101",[290,293],{"name":291,"role":129,"email":292},"Rick Walker","'Rick.Walker@health.qld.gov.au'",{"name":291,"role":133},{"lat":295,"lon":296},-27.48034,153.02049,{"facility":298,"status":8,"city":299,"state":272,"zip":300,"country":142,"contacts":301,"geoPoint":309},"Princess Alexandra","Woolloongabba","4102",[302,305,308],{"name":303,"role":129,"email":304},"Paul Baxter","Paul.Baxter@health.qld.gov.au",{"name":306,"role":129,"email":307},"Euan Walpole","Euan.Walpole@health.qld.gov.au",{"name":306,"role":133},{"lat":310,"lon":311},-27.48855,153.03655,{"facility":313,"status":8,"city":314,"state":315,"zip":316,"country":142,"contacts":317,"geoPoint":326},"Royal Adelaide Hospital","Adelaide","South Australia","5000",[318,321,324],{"name":319,"role":129,"email":320},"Hazel Bourke","hazel.bourke@health.sa.gov.au",{"name":322,"role":129,"email":323},"Thean Hsiang Tan","hsiang.tan@health.sa.gov.au",{"name":325,"role":133},"Thean Tan",{"lat":327,"lon":328},-34.92866,138.59863,{"facility":330,"status":331,"city":332,"state":315,"zip":333,"country":142,"geoPoint":334},"Flinders Medical Centre","ACTIVE_NOT_RECRUITING","Bedford Park","5042",{"lat":335,"lon":336},-35.02204,138.56815,{"facility":338,"status":8,"city":339,"state":340,"zip":341,"country":142,"contacts":342,"geoPoint":350},"Royal Hobart Hospital","Hobart","Tasmania","7000",[343,346,349],{"name":344,"role":129,"email":345},"Lesley Oliver","lesley.oliver@dhhs.tas.gov.au",{"name":347,"role":129,"email":348},"Rebecca Tay","rebecca.tay@ths.tas.gov.au",{"name":347,"role":133},{"lat":351,"lon":352},-42.87936,147.32941,{"facility":354,"status":8,"city":355,"state":356,"zip":357,"country":142,"contacts":358,"geoPoint":366},"Box Hill Hospital","Box Hill","Victoria","3128",[359,362,365],{"name":360,"role":129,"email":361},"Lauren Mitchell","lauren.mitchell@monash.edu",{"name":363,"role":129,"email":364},"Ian Davis","Ian.Davis@monash.edu",{"name":363,"role":133},{"lat":367,"lon":368},-37.81887,145.12545,{"facility":370,"status":8,"city":371,"state":356,"zip":372,"country":142,"contacts":373,"geoPoint":381},"Peter MacCallum Cancer Centre","East Melbourne","3002",[374,377,380],{"name":375,"role":129,"email":376},"Jennifer Petersen","jennifer.petersen@petermac.org",{"name":378,"role":129,"email":379},"Ben Tran","ben.tran@petermac.org",{"name":378,"role":133},{"lat":382,"lon":383},-37.81667,144.9879,{"facility":385,"status":8,"city":386,"state":356,"zip":387,"country":142,"contacts":388,"geoPoint":396},"Austin Health","Heidelberg","3084",[389,392,395],{"name":390,"role":129,"email":391},"Jaren Caine","Jaren.Caine@austin.org.au",{"name":393,"role":129,"email":394},"Andrew Weickhardt","Andrew.Weickhardt@ludwig.edu.au",{"name":393,"role":133},{"lat":397,"lon":398},-37.75,145.06667,{"facility":400,"status":224,"city":401,"state":356,"zip":402,"country":142,"geoPoint":403},"Sunshine Hospital","St Albans","3021",{"lat":404,"lon":405},-37.74496,144.80049,{"facility":407,"status":8,"city":408,"state":356,"zip":409,"country":142,"contacts":410,"geoPoint":418},"Border Medical Oncology","Wodonga","3690",[411,414,417],{"name":412,"role":129,"email":413},"Lauren Callow","lcallow@bordermedonc.com.au",{"name":415,"role":129,"email":416},"Craig Underhill","cunderhill@bordermedonc.com.au",{"name":415,"role":133},{"lat":419,"lon":420},-36.12179,146.88809,{"facility":422,"status":8,"city":423,"state":424,"zip":425,"country":142,"contacts":426,"geoPoint":434},"Fiona Stanley Hospital","Murdoch","Western Australia","6847",[427,430,433],{"name":428,"role":129,"email":429},"Jaye Harding","jaye.harding@health.wa.gov.au",{"name":431,"role":129,"email":432},"Simon Troon","simon.troon@health.wa.gov.au",{"name":431,"role":133},{"lat":435,"lon":436},-32.06987,115.83757,{"facility":438,"status":8,"city":439,"state":440,"zip":441,"country":442,"contacts":443,"geoPoint":448},"Starship Children's Hospital","Grafton","Auckland","1023","New Zealand",[444,447],{"name":445,"role":129,"email":446},"Mark Winstanley","'mwinstanley@adhb.govt.nz'",{"name":445,"role":133},{"lat":449,"lon":450},-36.86029,174.76566,{"facility":452,"status":8,"city":439,"state":440,"zip":453,"country":442,"contacts":454,"geoPoint":462},"Auckland Hospital","1142",[455,458,461],{"name":456,"role":129,"email":457},"Andrew Conley","andrewcon@adhb.govt.nz",{"name":459,"role":129,"email":460},"Fritha Hanning","FrithaH@adhb.govt.nz",{"name":459,"role":133},{"lat":449,"lon":450},{"facility":464,"status":8,"city":465,"state":466,"zip":467,"country":442,"contacts":468,"geoPoint":476},"Palmerston North Hospital","Roslyn","Palmerston North","4442",[469,472,475],{"name":470,"role":129,"email":471},"Sarah Holwell","Sarah.Holwell@midcentraldhb.govt.nz",{"name":473,"role":129,"email":474},"Gary Forgeson","Garry.Forgeson@midcentraldhb.govt.nz",{"name":473,"role":133},{"lat":477,"lon":478},-45.86667,170.48333,{"facility":480,"status":8,"city":481,"zip":482,"country":442,"contacts":483,"geoPoint":491},"Christchurch Hospital","Christchurch","8011",[484,487,490],{"name":485,"role":129,"email":486},"Elizabeth Thompson","liz.thompson@cdhb.health.nz",{"name":488,"role":129,"email":489},"Mark Jeffrey","Mark.jeffery@cdhb.health.nz",{"name":488,"role":133},{"lat":492,"lon":493},-43.53333,172.63333,{"facility":495,"status":224,"city":496,"zip":497,"country":442,"geoPoint":498},"Dunedin Hospital","Dunedin","9054",{"lat":499,"lon":500},-45.87416,170.50361,[502,506],{"name":503,"role":129,"phone":504,"phoneExt":316,"email":505},"P3BEP Trial Coordinator","+6195625000","p3bep@ctc.usyd.edu.au",{"name":507,"role":129,"phone":504,"phoneExt":316,"email":505},"P3BEP Project Manager",[509],{"name":193,"affiliation":186,"role":510},"STUDY_CHAIR",[512],{"pmid":513,"type":514,"citation":515},"30157803","DERIVED","Lawrence NJ, Chan H, Toner G, Stockler MR, Martin A, Yip S, Wong N, Yeung A, Mazhar D, Pashankar F, Frazier L, McDermott R, Walker R, Tan H, Davis ID, Grimison P; ANZUP. Protocol for the P3BEP trial (ANZUP 1302): an international randomised phase 3 trial of accelerated versus standard BEP chemotherapy for adult and paediatric male and female patients with intermediate and poor-risk metastatic germ cell tumours. BMC Cancer. 2018 Aug 29;18(1):854. doi: 10.1186\u002Fs12885-018-4745-3.",[],{"nct_id":4,"conditions":518,"biomarkers":519},[19],[520,521],"Alpha-Fetoprotein","Human Chorionic Gonadotropin",{"nct_id":4,"found":15,"summary":523,"prompt_version":533},{"design":524,"status":525,"heading":526,"summary":527,"follow_up":528,"word_count":529,"commitments":530,"compensation":531,"drugs_mentioned":532},"This interventional study plans to enroll 500 participants and compares two different chemotherapy schedules.","completed","Accelerated vs. Standard Chemotherapy for Metastatic Germ Cell Tumors","This study is comparing two ways of giving chemotherapy for metastatic germ cell tumors (a type of cancer that starts in reproductive cells). It's testing if an \"accelerated\" schedule of Bleomycin, Etoposide, and Cisplatin, along with Pegylated G-CSF or Filgrastim (medications to help with side effects), works better than the standard schedule. The study aims to enroll 500 patients aged 11 to 50 years old who have intermediate or poor-risk metastatic germ cell tumors. Researchers will measure how long patients live without their disease getting worse or until death, for up to 5 years. The current status of this study is unclear.","Your progression-free survival (time until disease progression or death) will be assessed for up to 5 years.",102,"Not specified in the trial record.","Not stated in the trial record.",[43,52,66],"v2"]