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 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