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
2023
P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate- and poor-risk metastatic germ cell tumours (GCTs).
Zebic D, Stockler M, Martin A, Pashankar F, Tran B, Mazhar D, Huddart R, Wheater M, Walpole E, Dunwoodie E, Feldman D, Birtle A, Stevanovic A, Wyld D, Hanning F, Grimison P, Group A. P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate- and poor-risk metastatic germ cell tumours (GCTs). Journal Of Clinical Oncology 2023, 41: tps431-tps431. DOI: 10.1200/jco.2023.41.6_suppl.tps431.Peer-Reviewed Original ResearchPoor-risk metastatic germ cell tumoursMetastatic germ cell tumorsGerm cell tumorsPhase 3 trialStandard BEPComplete responseStage ITwo-sided type IRandomized phase 3 trialCisplatin 20mg/Standard BEP chemotherapyBaseline blood samplesProgression-free survivalTrial of chemotherapyImproved cure ratesD1-5Post-chemotherapy treatmentTranslational substudyBEP chemotherapyLine chemotherapyOpen labelPrimary endpointStandard regimensFree survivalCR rate
2020
P3BEP (ANZUP 1302): An international randomized phase III trial of accelerated versus standard BEP chemotherapy for adult and pediatric male and female patients with intermediate and poor-risk metastatic germ cell tumors (GCTs).
Subramaniam S, Toner G, Stockler M, Martin A, Pashankar F, Frazier A, Mazhar D, Ford K, Walpole E, Stevanovic A, Wyld D, Troon S, Hanning F, Birtle A, Wheater M, Huddart R, White J, Spunt S, Grimison P. P3BEP (ANZUP 1302): An international randomized phase III trial of accelerated versus standard BEP chemotherapy for adult and pediatric male and female patients with intermediate and poor-risk metastatic germ cell tumors (GCTs). Journal Of Clinical Oncology 2020, 38: tps425-tps425. DOI: 10.1200/jco.2020.38.6_suppl.tps425.Peer-Reviewed Original ResearchMetastatic germ cell tumorsGerm cell tumorsProgression-free survivalPoor-risk metastatic germ cell tumoursStandard BEPLine chemotherapyInternational randomized phase III trialExtracranial germ cell tumorsRandomized phase III trialCisplatin 20mg/Standard BEP chemotherapyFavorable response ratePhase 3 trialPhase III trialsD1-5Age group malesArchival tumor tissueFormal interim analysisShorter cycle lengthsTranslational substudyBEP chemotherapyOpen labelPrimary endpointStandard regimenBaseline blood
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 BEPP3BEP (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 (GCTs).
Grimison P, Lawrence N, Stockler M, Martin A, Yip S, Wong N, Yeung A, Friedlander M, Mazhar D, Pashankar F, Quinn D, McDermott R, Walker R, Winstanley M, Hanning F, Weickhardt A, Stevanovic A, Davis I, Toner G. P3BEP (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 (GCTs). Journal Of Clinical Oncology 2018, 36: tps4596-tps4596. DOI: 10.1200/jco.2018.36.15_suppl.tps4596.Peer-Reviewed Original ResearchP3BEP (ANZUP 1302): An international randomized 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 tumors (GCTs).
Nayar N, Lawrence N, Stockler M, Martin A, Yip S, Wong N, Yeung A, Friedlander M, Mazhar D, Pashankar F, Quinn D, McDermott R, Walker R, Winstanley M, Hanning F, Weickhardt A, Stevanovic A, Davis I, Toner G, Grimison P. P3BEP (ANZUP 1302): An international randomized 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 tumors (GCTs). Journal Of Clinical Oncology 2018, 36: tps574-tps574. DOI: 10.1200/jco.2018.36.6_suppl.tps574.Peer-Reviewed Original ResearchMetastatic germ cell tumorsGerm cell tumorsProgression-free survivalPoor-risk metastatic germ cell tumoursPhase 3 trialResponse rateLine chemotherapyStandard BEPExtracranial germ cell tumorsRandomized phase 3 trialCisplatin 20mg/Complete response rateStandard BEP chemotherapyAge group malesArchival tumor tissuePEG-G-CSFShorter cycle lengthsTranslational substudyBEP chemotherapyOpen labelPrimary endpointStandard regimenBaseline bloodFree survivalWeekly doses
2017
P3BEP (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 (GCTs).
Grimison P, Lawrence N, Stockler M, Martin A, Yip S, Wong N, Yeung A, Friedlander M, Mazhar D, Pashankar F, Quinn D, Walker R, Winstanley M, Hanning F, Weickhardt A, Stevanovic A, Davis I, Toner G. P3BEP (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 (GCTs). Journal Of Clinical Oncology 2017, 35: tps4592-tps4592. DOI: 10.1200/jco.2017.35.15_suppl.tps4592.Peer-Reviewed Original ResearchMetastatic germ cell tumorsGerm cell tumorsProgression-free survivalPoor-risk metastatic germ cell tumoursPhase 3 trialResponse rateStandard BEPLine chemotherapyCancer AustraliaDay 1Randomised phase 3 trialStandard BEP chemotherapyComplete response ratePediatric age groupArchival tumor tissueCancer Council AustraliaTranslational substudyBaseline bloodBEP chemotherapyFree survivalPrimary endpointWeekly dosesFemale patientsCure rateCell tumors