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
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