2024
P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for individuals aged 11-45 years with intermediate and poor-risk metastatic germ cell tumours (GCTs).
Mak B, Tran B, Pashankar F, Mazhar D, Huddart R, Wheater M, Walpole E, Feldman D, Dunwoodie E, Lawrence N, Birtle A, Wyld D, Stevanovic A, Balagtas J, Stockler M, Davis I. P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for individuals aged 11-45 years with intermediate and poor-risk metastatic germ cell tumours (GCTs). Journal Of Clinical Oncology 2024, 42: tps524-tps524. DOI: 10.1200/jco.2024.42.4_suppl.tps524.Peer-Reviewed Original ResearchMetastatic germ cell tumorsGerm cell tumorsPhase 3 trialTwo-sided type I error rateRandomized trials of chemotherapyRandomized phase 3 trialResponse rateProgression free survivalFirst-line chemotherapyStandard chemotherapy regimensFavorable response rateImprove cure ratesTrials of chemotherapyBaseline blood samplesPost-chemotherapy treatmentStage 1BEP chemotherapyStandard BEPTranslational substudyFree survivalChemotherapy regimensOpen-labelStage 2Primary endpointCell tumors
2021
P3BEP (ANZUP 1302): An international randomized phase III trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate and poor-risk metastatic germ cell tumors (GCTs).
Subramaniam S, Toner G, Stockler M, Martin A, Pashankar F, Tran B, Jeffery M, Mazhar D, Huddart R, Walpole E, Stevanovic A, Wyld D, Hanning F, Wheater M, Balagtas J, Troon S, Birtle A, White J, Grimison P. P3BEP (ANZUP 1302): An international randomized phase III trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate and poor-risk metastatic germ cell tumors (GCTs). Journal Of Clinical Oncology 2021, 39: tps390-tps390. DOI: 10.1200/jco.2021.39.6_suppl.tps390.Peer-Reviewed Original ResearchMetastatic germ cell tumorsPoor-risk metastatic germ cell tumoursGerm cell tumorsStandard BEPComplete responseStage IInternational randomized phase III trialRandomized phase III trialStandard first-line chemotherapyCisplatin 20mg/Standard BEP chemotherapyBaseline blood samplesFirst-line chemotherapyPhase III trialsProgression-free survivalTrial of chemotherapyD1-5Post-chemotherapy treatmentClinical trial informationTranslational substudyBEP chemotherapyOpen labelPrimary endpointStandard regimensFree survival
2018
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
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, on behalf of 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, 18: 854. PMID: 30157803, PMCID: PMC6114870, DOI: 10.1186/s12885-018-4745-3.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsBleomycinChildChild, PreschoolCisplatinClinical ProtocolsClinical Trials, Phase III as TopicEtoposideFemaleHumansInfantInfant, NewbornMaleMulticenter Studies as TopicNeoplasms, Germ Cell and EmbryonalRandomized Controlled Trials as TopicResearch DesignYoung AdultConceptsPoor-risk metastatic germ cell tumoursMetastatic germ cell tumorsGerm cell tumorsStandard BEP chemotherapyFirst-line chemotherapyCell tumorsLine chemotherapyBEP chemotherapyCure rateClinical trialsPoor-risk germ cell tumorsMulticentre phase 2 trialRandomised phase 3 trialStandard first-line treatmentPhase 3 clinical trialsComplete response rateFirst-line treatmentPhase 2 trialPhase 3 trialProgression-free survivalHealth-related qualityPediatric age groupFemale participantsInternational multicentreStandard BEP