2025
P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for individuals aged 11-50 years with intermediate and poor-risk metastatic germ cell tumours (GCTs).
Mak B, Tran B, Thomas H, Pashankar F, Hansen A, Feldman D, Huddart R, Wheater M, Dunwoodie E, Mazhar D, Lawrence N, Stevanovic A, Birtle A, Oladipo O, Wyld D, Balagtas J, Stockler M, Grimison P. P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for individuals aged 11-50 years with intermediate and poor-risk metastatic germ cell tumours (GCTs). Journal Of Clinical Oncology 2025, 43: tps653-tps653. DOI: 10.1200/jco.2025.43.5_suppl.tps653.Peer-Reviewed Original ResearchMetastatic germ cell tumorsGerm cell tumorsProgression free survivalPhase 3 trialTwo-sided type I error rateRandomized trials of chemotherapyRandomized phase 3 trialIndependent data safety monitoring committeeData Safety Monitoring CommitteeResponse rateFirst-line chemotherapyStandard chemotherapy regimensFavorable response rateImprove cure ratesTrials of chemotherapyBaseline blood samplesSafety Monitoring CommitteePost-chemotherapy treatmentStage 1BEP chemotherapyStandard BEPTranslational substudyFree survivalChemotherapy regimensIntermediate-risk
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