[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100290931":3},{"organization":4,"armGroups":7,"interventions":40,"overallOfficials":223,"centralContacts":222,"locations":227,"responsibleParty":7102,"collaborators":7104,"id":7108,"slug":7109,"hasResults":7110,"nctId":7111,"briefTitle":7112,"officialTitle":7113,"acronym":222,"eligibilityCriteria":7114,"healthyVolunteers":7110,"sex":7115,"minAge":222,"maxAge":222,"enrollmentInfo":7116,"targetDuration":222,"studyType":7119,"phases":7120,"briefSummary":7122,"conditions":7123,"keywords":222,"overallStatus":230,"whyStopped":222,"lastUpdateSubmitDate":7154,"lastUpdatePostDateStruct":7155,"startDateStruct":7158,"completionDateStruct":7160,"leadSponsor":7162,"locationsCount":7163},{"fullName":5,"class":6},"Children's Oncology Group","NETWORK",[8,22,27,31,35],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm I (bleomycin, carboplatin, etoposide)","EXPERIMENTAL","Patients receive bleomycin IV over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and\u002For chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.",[13,14,15,16,17,18,19,20,21],"Procedure: Biopsy Procedure","Procedure: Biospecimen Collection","Biological: Bleomycin Sulfate","Drug: Carboplatin","Procedure: Computed Tomography","Drug: Etoposide","Procedure: Magnetic Resonance Imaging","Procedure: Pulmonary Function Test","Other: Questionnaire Administration",{"label":23,"type":10,"description":24,"interventionNames":25},"Arm II (bleomycin, etoposide, cisplatin)","Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and\u002For chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.",[13,14,15,26,17,18,19,20,21],"Drug: Cisplatin",{"label":28,"type":10,"description":29,"interventionNames":30},"Arm III (bleomycin, etoposide, carboplatin)","Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and\u002For chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.",[13,14,15,16,17,18,19,20,21],{"label":32,"type":10,"description":33,"interventionNames":34},"Arm IV (bleomycin, etoposide, cisplatin)","Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and\u002For chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.",[13,14,15,26,17,18,19,20,21],{"label":36,"type":10,"description":37,"interventionNames":38},"Low-Risk (observation)","Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I non-seminoma or seminoma MGCTs undergo observation and can transfer to standard risk arm when eligibility criteria are met. Patients with stage I seminoma testicular MGCT undergo observation, and those with residual\u002Frecurrent disease are treated at the discretion of their physician. Patients undergo CT, MRI, and\u002For chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial.",[39,13,14,17,19,21],"Other: Best Practice",[41,49,58,66,84,109,155,172,189,209,218],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"OTHER","Best Practice","Undergo observation",[36],[47,48],"standard of care","standard therapy",{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"PROCEDURE","Biopsy Procedure","Undergo a tumor biopsy",[9,23,28,32,36],[55,56,57],"Biopsy","BIOPSY_TYPE","Bx",{"type":50,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Biospecimen Collection","Undergo blood sample collection",[9,23,28,32,36],[63,64,65],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"BIOLOGICAL","Bleomycin Sulfate","Given IV",[9,23,28,32],[72,73,74,75,76,77,78,79,80,81,82,83],"Blanoxan","BleMomycine","Blenoxane","Bleo-cell","Bleo-S","Bleocin","Bleolem","Bleomycin Sulfas","Bleomycin Sulphate","Bleomycini Sulfas","Blexane","Oil Bleo",{"type":85,"name":86,"description":69,"armGroupLabels":87,"otherNames":88},"DRUG","Carboplatin",[9,28],[89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108],"Blastocarb","Carboplat","Carboplatin Hexal","Carboplatino","Carboplatinum","Carbosin","Carbosol","Carbotec","CBDCA","Displata","Ercar","JM-8","JM8","Nealorin","Novoplatinum","Paraplatin","Paraplatin AQ","Paraplatine","Platinwas","Ribocarbo",{"type":85,"name":110,"description":69,"armGroupLabels":111,"otherNames":112},"Cisplatin",[23,32],[113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154],"Abiplatin","Blastolem","Briplatin","CDDP","Cis-diammine-dichloroplatinum","Cis-diamminedichloridoplatinum","Cis-diamminedichloro Platinum (II)","Cis-diamminedichloroplatinum","Cis-dichloroammine Platinum (II)","Cis-platinous Diamine Dichloride","Cis-platinum","Cis-platinum II","Cis-platinum II Diamine Dichloride","Cismaplat","Cisplatina","Cisplatinum","Cisplatyl","Citoplatino","Citosin","Cysplatyna","DDP","Lederplatin","Metaplatin","Neoplatin","Peyrone's Chloride","Peyrone's Salt","Placis","Plastistil","Platamine","Platiblastin","Platiblastin-S","Platinex","Platinol","Platinol- AQ","Platinol-AQ","Platinol-AQ VHA Plus","Platinoxan","Platinum","Platinum Diamminodichloride","Platiran","Platistin","Platosin",{"type":50,"name":156,"description":157,"armGroupLabels":158,"otherNames":159},"Computed Tomography","Undergo a CT scan",[9,23,28,32,36],[160,161,162,163,164,165,166,167,168,169,170,171],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography",{"type":85,"name":173,"description":69,"armGroupLabels":174,"otherNames":175},"Etoposide",[9,23,28,32],[176,177,178,179,180,181,182,183,184,185,186,187,188],"Demethyl Epipodophyllotoxin Ethylidine Glucoside","EPEG","Lastet","Toposar","Vepesid","VP 16","VP 16-213","VP 16213","VP-16","VP-16-213","VP-16213","VP16","VP16213",{"type":50,"name":190,"description":191,"armGroupLabels":192,"otherNames":193},"Magnetic Resonance Imaging","Undergo MRI",[9,23,28,32,36],[194,195,196,197,198,199,200,201,202,203,204,205,206,207,208],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":50,"name":210,"description":211,"armGroupLabels":212,"otherNames":213},"Pulmonary Function Test","Undergo a pulmonary function test",[9,23,28,32],[214,215,216,217],"lung function test","PFT","Pulmonary Function Testing","Pulmonary Function Tests",{"type":42,"name":219,"description":220,"armGroupLabels":221,"otherNames":222},"Questionnaire Administration","Ancillary studies",[9,23,28,32,36],null,[224],{"name":225,"affiliation":5,"role":226},"A. 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Alva",{"facility":251,"status":252,"city":253,"state":232,"zip":254,"country":234,"countryCode":235,"cosmosGeoPoint":255,"geoPoint":259,"contacts":222},"USA Health Strada Patient Care Center","SUSPENDED","Mobile","36604",{"type":237,"coordinates":256},[257,258],-88.04305,30.69436,{"lat":258,"lon":257},{"facility":261,"status":230,"city":262,"state":263,"zip":264,"country":234,"countryCode":235,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"Anchorage Associates in Radiation Medicine","Anchorage","Alaska","98508",{"type":237,"coordinates":266},[267,268],-149.90028,61.21806,{"lat":268,"lon":267},[271,274],{"name":244,"role":245,"phone":272,"phoneExt":222,"email":273},"907-212-6871","AKPAMC.OncologyResearchSupport@providence.org",{"name":275,"role":226,"phone":222,"phoneExt":222,"email":222},"Dan S. Zuckerman",{"facility":277,"status":252,"city":262,"state":263,"zip":278,"country":234,"countryCode":235,"cosmosGeoPoint":279,"geoPoint":281,"contacts":222},"Anchorage Radiation Therapy Center","99504",{"type":237,"coordinates":280},[267,268],{"lat":268,"lon":267},{"facility":283,"status":230,"city":262,"state":263,"zip":284,"country":234,"countryCode":235,"cosmosGeoPoint":285,"geoPoint":287,"contacts":288},"Alaska Breast Care and Surgery LLC","99508",{"type":237,"coordinates":286},[267,268],{"lat":268,"lon":267},[289,290],{"name":244,"role":245,"phone":272,"phoneExt":222,"email":273},{"name":275,"role":226,"phone":222,"phoneExt":222,"email":222},{"facility":292,"status":230,"city":262,"state":263,"zip":284,"country":234,"countryCode":235,"cosmosGeoPoint":293,"geoPoint":295,"contacts":296},"Alaska Oncology and Hematology LLC",{"type":237,"coordinates":294},[267,268],{"lat":268,"lon":267},[297,298],{"name":244,"role":245,"phone":272,"phoneExt":222,"email":273},{"name":275,"role":226,"phone":222,"phoneExt":222,"email":222},{"facility":300,"status":230,"city":262,"state":263,"zip":284,"country":234,"countryCode":235,"cosmosGeoPoint":301,"geoPoint":303,"contacts":304},"Alaska Women's Cancer Care",{"type":237,"coordinates":302},[267,268],{"lat":268,"lon":267},[305,306],{"name":244,"role":245,"phone":272,"phoneExt":222,"email":273},{"name":275,"role":226,"phone":222,"phoneExt":222,"email":222},{"facility":308,"status":252,"city":262,"state":263,"zip":284,"country":234,"countryCode":235,"cosmosGeoPoint":309,"geoPoint":311,"contacts":222},"Anchorage Oncology Centre",{"type":237,"coordinates":310},[267,268],{"lat":268,"lon":267},{"facility":313,"status":230,"city":262,"state":263,"zip":284,"country":234,"countryCode":235,"cosmosGeoPoint":314,"geoPoint":316,"contacts":317},"Katmai Oncology Group",{"type":237,"coordinates":315},[267,268],{"lat":268,"lon":267},[318,319],{"name":244,"role":245,"phone":272,"phoneExt":222,"email":273},{"name":275,"role":226,"phone":222,"phoneExt":222,"email":222},{"facility":321,"status":230,"city":262,"state":263,"zip":284,"country":234,"countryCode":235,"cosmosGeoPoint":322,"geoPoint":324,"contacts":325},"Providence Alaska Medical Center",{"type":237,"coordinates":323},[267,268],{"lat":268,"lon":267},[326,327],{"name":244,"role":245,"phone":272,"phoneExt":222,"email":273},{"name":275,"role":226,"phone":222,"phoneExt":222,"email":222},{"facility":329,"status":230,"city":330,"state":331,"zip":332,"country":234,"countryCode":235,"cosmosGeoPoint":333,"geoPoint":337,"contacts":338},"Kingman Regional Medical Center","Kingman","Arizona","86401",{"type":237,"coordinates":334},[335,336],-114.05301,35.18944,{"lat":336,"lon":335},[339,342],{"name":244,"role":245,"phone":340,"phoneExt":222,"email":341},"702-384-0013","research@sncrf.org",{"name":343,"role":226,"phone":222,"phoneExt":222,"email":222},"Alan K. Ikeda",{"facility":345,"status":230,"city":346,"state":331,"zip":347,"country":234,"countryCode":235,"cosmosGeoPoint":348,"geoPoint":352,"contacts":353},"Banner Children's at Desert","Mesa","85202",{"type":237,"coordinates":349},[350,351],-111.82264,33.42227,{"lat":351,"lon":350},[354,356],{"name":244,"role":245,"phone":355,"phoneExt":222,"email":222},"480-412-3100",{"name":357,"role":226,"phone":222,"phoneExt":222,"email":222},"Joseph C. Torkildson",{"facility":359,"status":360,"city":361,"state":331,"zip":362,"country":234,"countryCode":235,"cosmosGeoPoint":363,"geoPoint":367,"contacts":222},"Cancer Center at Saint Joseph's","ACTIVE_NOT_RECRUITING","Phoenix","85004",{"type":237,"coordinates":364},[365,366],-112.07404,33.44838,{"lat":366,"lon":365},{"facility":369,"status":230,"city":361,"state":331,"zip":370,"country":234,"countryCode":235,"cosmosGeoPoint":371,"geoPoint":373,"contacts":374},"Phoenix Childrens Hospital","85016",{"type":237,"coordinates":372},[365,366],{"lat":366,"lon":365},[375,377],{"name":244,"role":245,"phone":376,"phoneExt":222,"email":222},"602-546-0920",{"name":378,"role":226,"phone":222,"phoneExt":222,"email":222},"Alok K. Kothari",{"facility":380,"status":360,"city":381,"state":331,"zip":382,"country":234,"countryCode":235,"cosmosGeoPoint":383,"geoPoint":387,"contacts":222},"Banner University Medical Center - Tucson","Tucson","85719",{"type":237,"coordinates":384},[385,386],-110.92648,32.22174,{"lat":386,"lon":385},{"facility":389,"status":360,"city":381,"state":331,"zip":382,"country":234,"countryCode":235,"cosmosGeoPoint":390,"geoPoint":392,"contacts":222},"University of Arizona Cancer Center-North Campus",{"type":237,"coordinates":391},[385,386],{"lat":386,"lon":385},{"facility":394,"status":252,"city":395,"state":396,"zip":397,"country":234,"countryCode":235,"cosmosGeoPoint":398,"geoPoint":402,"contacts":222},"CHI Saint Vincent Cancer Center Hot Springs","Hot Springs","Arkansas","71913",{"type":237,"coordinates":399},[400,401],-93.05518,34.5037,{"lat":401,"lon":400},{"facility":404,"status":230,"city":405,"state":396,"zip":406,"country":234,"countryCode":235,"cosmosGeoPoint":407,"geoPoint":411,"contacts":412},"Arkansas Children's Hospital","Little Rock","72202-3591",{"type":237,"coordinates":408},[409,410],-92.28959,34.74648,{"lat":410,"lon":409},[413,415],{"name":244,"role":245,"phone":414,"phoneExt":222,"email":222},"501-364-7373",{"name":416,"role":226,"phone":222,"phoneExt":222,"email":222},"Michael W. 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7BE",{"type":237,"coordinates":6974},[6975,6976],-0.12574,51.50853,{"lat":6976,"lon":6975},[6979,6980],{"name":244,"role":245,"phone":222,"phoneExt":222,"email":1353},{"name":6957,"role":226,"phone":222,"phoneExt":222,"email":222},{"facility":6982,"status":230,"city":2436,"state":6944,"zip":6983,"country":6946,"countryCode":6947,"cosmosGeoPoint":6984,"geoPoint":6986,"contacts":6987},"University College London Hospitals NHS Trust - Foley Street","W1W 6DN",{"type":237,"coordinates":6985},[6975,6976],{"lat":6976,"lon":6975},[6988,6989],{"name":244,"role":245,"phone":222,"phoneExt":222,"email":1353},{"name":6957,"role":226,"phone":222,"phoneExt":222,"email":222},{"facility":6991,"status":230,"city":6992,"state":6944,"zip":6993,"country":6946,"countryCode":6947,"cosmosGeoPoint":6994,"geoPoint":6998,"contacts":6999},"Royal Manchester Children Hospital","Manchester","M27 4HA",{"type":237,"coordinates":6995},[6996,6997],-2.23743,53.48095,{"lat":6997,"lon":6996},[7000,7001],{"name":244,"role":245,"phone":222,"phoneExt":222,"email":1353},{"name":6957,"role":226,"phone":222,"phoneExt":222,"email":222},{"facility":7003,"status":230,"city":7004,"state":6944,"zip":7005,"country":6946,"countryCode":6947,"cosmosGeoPoint":7006,"geoPoint":7010,"contacts":7011},"Royal Victoria Infirmary","Newcastle","NE1 4LP",{"type":237,"coordinates":7007},[7008,7009],-3.11667,52.43333,{"lat":7009,"lon":7008},[7012,7013],{"name":244,"role":245,"phone":222,"phoneExt":222,"email":1353},{"name":6957,"role":226,"phone":222,"phoneExt":222,"email":222},{"facility":7015,"status":230,"city":7016,"state":6944,"zip":7017,"country":6946,"countryCode":6947,"cosmosGeoPoint":7018,"geoPoint":7022,"contacts":7023},"Freeman Hospital","Newcastle upon Tyne","NE7 7DN",{"type":237,"coordinates":7019},[7020,7021],-1.61396,54.97328,{"lat":7021,"lon":7020},[7024,7025],{"name":244,"role":245,"phone":222,"phoneExt":222,"email":1353},{"name":6957,"role":226,"phone":222,"phoneExt":222,"email":222},{"facility":7027,"status":230,"city":7028,"state":6944,"zip":7029,"country":6946,"countryCode":6947,"cosmosGeoPoint":7030,"geoPoint":7034,"contacts":7035},"John Radcliffe Hospital","Oxford","OX3 9DU",{"type":237,"coordinates":7031},[7032,7033],-1.25596,51.75222,{"lat":7033,"lon":7032},[7036,7037],{"name":244,"role":245,"phone":222,"phoneExt":222,"email":1353},{"name":6957,"role":226,"phone":222,"phoneExt":222,"email":222},{"facility":7039,"status":252,"city":7040,"state":6944,"zip":7041,"country":6946,"countryCode":6947,"cosmosGeoPoint":7042,"geoPoint":7046,"contacts":222},"Weston Park Hospital","Sheffield","S10 2SJ",{"type":237,"coordinates":7043},[7044,7045],-1.4659,53.38297,{"lat":7045,"lon":7044},{"facility":7048,"status":230,"city":7049,"state":6944,"zip":7050,"country":6946,"countryCode":6947,"cosmosGeoPoint":222,"geoPoint":222,"contacts":7051},"Saint James's University Hospital","West Yorkshire","LS9 7TF",[7052,7053],{"name":244,"role":245,"phone":222,"phoneExt":222,"email":1353},{"name":6957,"role":226,"phone":222,"phoneExt":222,"email":222},{"facility":7055,"status":230,"city":7056,"state":7057,"zip":7058,"country":6946,"countryCode":6947,"cosmosGeoPoint":7059,"geoPoint":7063,"contacts":7064},"Western General Hospital","Edinburgh","Scotland","EH4 2XU",{"type":237,"coordinates":7060},[7061,7062],-3.19648,55.95206,{"lat":7062,"lon":7061},[7065,7066],{"name":244,"role":245,"phone":222,"phoneExt":222,"email":1353},{"name":6957,"role":226,"phone":222,"phoneExt":222,"email":222},{"facility":7068,"status":230,"city":7056,"state":7057,"zip":7069,"country":6946,"countryCode":6947,"cosmosGeoPoint":7070,"geoPoint":7072,"contacts":7073},"Royal Hospital for Children and Young People","EH9 1LF",{"type":237,"coordinates":7071},[7061,7062],{"lat":7062,"lon":7061},[7074,7076],{"name":244,"role":245,"phone":7075,"phoneExt":222,"email":222},"0131 536 1000",{"name":6957,"role":226,"phone":222,"phoneExt":222,"email":222},{"facility":7078,"status":252,"city":7079,"state":7057,"zip":7080,"country":6946,"countryCode":6947,"cosmosGeoPoint":7081,"geoPoint":7085,"contacts":222},"Beatson Oncology Center","Glasgow","G12 0YN",{"type":237,"coordinates":7082},[7083,7084],-4.25763,55.86515,{"lat":7084,"lon":7083},{"facility":7087,"status":230,"city":7079,"state":7057,"zip":7088,"country":6946,"countryCode":6947,"cosmosGeoPoint":7089,"geoPoint":7091,"contacts":7092},"Royal Hospital for Children","G51 4TF",{"type":237,"coordinates":7090},[7083,7084],{"lat":7084,"lon":7083},[7093,7095],{"name":244,"role":245,"phone":222,"phoneExt":222,"email":7094},"Randdsystems.PF1@ggc.scot.nhs.uk",{"name":6957,"role":226,"phone":222,"phoneExt":222,"email":222},{"facility":7097,"status":230,"city":7049,"state":222,"zip":7098,"country":6946,"countryCode":6947,"cosmosGeoPoint":222,"geoPoint":222,"contacts":7099},"Leeds General Infirmary","LS1 3EX",[7100,7101],{"name":244,"role":245,"phone":222,"phoneExt":222,"email":1353},{"name":6957,"role":226,"phone":222,"phoneExt":222,"email":222},{"type":7103,"investigatorFullName":222,"investigatorTitle":222,"investigatorAffiliation":222,"oldNameTitle":222,"oldOrganization":222},"SPONSOR",[7105],{"name":7106,"class":7107},"National Cancer Institute (NCI)","NIH","100290931","phase-3-active-surveillance-bleomycin-etoposide-carboplatin-or-cisplatin-in-treating-pediatric-and-adult-patients-with-germ-cell-tumors-100290931",false,"NCT03067181","Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors","A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors","Inclusion Criteria:\n\n* There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT \\[all sites\\])\n* Standard risk 1: Patients must be \\\u003C 11 years of age at enrollment\n* Standard risk 2: Patients must be \\>= 11 and \\\u003C 25 years of age at enrollment\n* Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with malignant germ cell tumor (stage II or higher).\n\n  * Histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment , with the following exceptions:\n\n    * Among patients were initially diagnosed with completely resected non-seminoma malignant GCT and later recur during observation post surgery, a diagnostic biopsy is not required for enrollment if elevated tumor markers rise to \\> 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart. The pathology report of initial surgery should be provided\n    * Patients may be enrolled without histologic or cytologic confirmation in the rare case where there are exceptionally raised tumor markers (alpha fetoprotein \\[AFP- ≥ 500 ng\u002FmL or HCG ≥ 500 IU\u002FL) and radiologic features consistent with GCT. In addition, the treating clinician must deem that the patient's tumor is not suitable for upfront resection and that a biopsy is not in the patient's best interest; or that there is a need to start therapy urgently\n* Low risk immature teratoma (IT); site: ovarian; stage: any; grade: any; histology: pure immature teratoma, mixed immature and mature teratoma, (may contain microscopic foci of yolk sac tumor \\[\\\u003C 3 mm\\], but no other pathological evidence of MGCT); tumor markers: alpha-FP =\\\u003C 1,000 ng\u002FmL, beta-HCG institutional normal; all ages\n* Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages\n* Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain only seminoma; may contain immature\u002Fmature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages\n* Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC-IV, (International Germ Cell Consensus Classification \\[IGCCC\\] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \\\u003C 11\n* Standard risk 2 (SR2)\n\n  * Site: ovarian; stage: COG stage II, III, and III-X, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \\>= 11 and \\\u003C 25\n  * Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma: must be IGCCC good risk; post op: alpha-FP \\\u003C 1,000 ng\u002FmL, beta-HCG \\\u003C 5,000 IU\u002FmL and lactate dehydrogenase (LDH) \\\u003C 3.0 x normal; age (years) \\>= 11 and \\\u003C 25\n* Notes:\n\n  * IGCCC criteria only apply to SR2 patients with a testicular primary tumor\n  * Use post-op tumor marker levels to determine IGCCC risk group\n  * Pure seminoma patients are not eligible for the standard risk arms of the study\n  * For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a \"microscopic component\" of yolk sac tumor\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age\n* Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)\n* Adequate renal function defined as:\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 (within 7 days prior to enrollment) OR\n* A serum creatinine based on age\u002Fsex as follows (within 7 days prior to enrollment): (mg\u002FdL)\n\n  * 1 month to \\\u003C 6 months male: 0.4 female: 0.4\n  * 6 months to \\\u003C 1 year male: 0.5 female: 0.5\n  * 1 to \\\u003C 2 years male: 0.6 female: 0.6\n  * 2 to \\\u003C 6 years male: 0.8 female: 0.8\n  * 6 to \\\u003C 10 years male: 1 female: 1\n  * 10 to \\\u003C 13 years male: 1.2 female: 1.2\n  * 13 to \\\u003C 16 years: male: 1.5 female: 1.4\n  * \\>= 16 years male: 1.7 female: 1.4\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x upper limit of normal (ULN) (within 7 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome\n* Peripheral absolute neutrophil count (ANC) \\>= 750\u002Fmm\\^3 (within 7 days prior to enrollment) AND\n* Platelet count \\>= 75,000\u002Fmm\\^3 (within 7 days prior to enrollment)\n* Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment\n* Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes \\[PROs\\] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate\n* \\>= 11 and \\\u003C 25 years old at enrollment\n* Able to fluently speak and read English\n* Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor\n* Followed for cancer or survivorship care at one of the following institutions:\n\n  * Baylor College of Medicine\u002FDan L Duncan Comprehensive Cancer Center\n  * Dana Farber\u002FHarvard Cancer Center\n  * Hospital for Sick Children\n  * Children's Hospital of Eastern Ontario\n  * Oregon Health and Science University\n  * Seattle Children's Hospital\n  * Yale University\n\nExclusion Criteria:\n\n* Patients with any diagnoses not listed including:\n\n  * Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)\n  * Pure ovarian or extragonadal dysgerminoma\u002Fseminoma\n  * Pure mature teratoma\n  * Pure immature teratoma with alpha-fetoprotein (AFP) \\>= 1000 ng\u002FmL\n  * \"Poor risk\" GCT (age \\>= 11 years old and COG stage IV ovarian, COG stage II- IV extragonadal, or IGCCC intermediate or poor risk testicular), or\n  * Primary central nervous system (CNS) germ cell tumor\n  * Germ cell tumor with somatic malignant transformation\n  * Spermatocytic seminoma\n* Patients must have had no prior systemic therapy for the current cancer diagnosis\n* Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain \\[stage IV disease\\] would be considered poor risk and therefore not eligible for this trial)\n* Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy \\[SR1 and SR2 patients\\])\n* Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy \\[SR1 and SR2 patients\\])\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy \\[SR1 and SR2 patients\\])","ALL",{"count":7117,"type":7118},1780,"ESTIMATED","INTERVENTIONAL",[7121],"PHASE3","This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.",[7124,7125,7126,7127,7128,7129,7130,7131,7132,7133,7134,7135,7136,7137,7138,7139,7140,7141,7142,7143,7144,7145,7146,7147,7148,7149,7150,7151,7152,7153],"Childhood Extracranial Germ Cell Tumor","Extragonadal Embryonal Carcinoma","Germ Cell Tumor","Malignant Germ Cell Tumor","Malignant Ovarian Teratoma","Stage I Ovarian Choriocarcinoma","Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7","Stage I Testicular Choriocarcinoma AJCC v6 and v7","Stage I Testicular Embryonal Carcinoma AJCC v6 and v7","Stage I Testicular Seminoma AJCC v6 and v7","Stage I Testicular Yolk Sac Tumor AJCC v6 and v7","Stage II Ovarian Choriocarcinoma","Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7","Stage II Testicular Choriocarcinoma AJCC v6 and v7","Stage II Testicular Embryonal Carcinoma AJCC v6 and v7","Stage II Testicular Yolk Sac Tumor AJCC v6 and v7","Stage III Ovarian Choriocarcinoma","Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7","Stage III Testicular Choriocarcinoma AJCC v6 and v7","Stage III Testicular Embryonal Carcinoma AJCC v6 and v7","Stage III Testicular Yolk Sac Tumor AJCC v6 and v7","Stage IV Ovarian Choriocarcinoma","Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7","Testicular Mixed Choriocarcinoma and Embryonal Carcinoma","Testicular Mixed Choriocarcinoma and Teratoma","Testicular Mixed Choriocarcinoma and Yolk Sac Tumor","2026-05-01",{"date":7156,"type":7157},"2026-05-05","ACTUAL",{"date":7159,"type":7157},"2017-05-25",{"date":7161,"type":7118},"2027-06-30",{"name":5,"class":6},629]