Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 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) (#272)

Nicole Wong 1 , Namrata Nayar 1 , Nicola Lawrence 1 , Martin Stockler 1 , Andrew Martin 1 , Sonia Yip 1 , Annie Yeung 1 , Michael` Friedlander 2 , Danish Mazhar 3 , Farzana Pashankar 4 , David Quinn 5 , Roderick Walker 6 , Mark Winstanley 7 , Andrew Weickhardt 8 , Fritha Hanning 9 , Amanda Stevanovic 10 , Ian Davis 11 , Guy Toner 12 , Peter Grimison 13
  1. NHMRC Clinical Trials Centre, Camperdown, NSW, Australia
  2. Medical Oncology, Prince of Wales Hospital, Sydney, NSW, Australia
  3. Medical Oncology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom
  4. School of Medicine, Yale University, New Haven, Connecticut, USA
  5. Division of Cancer Medicine and Blood Diseases, Department of Medicine, University of Southern California, Los Angeles, USA
  6. Oncology, Lady Cilento Children's Hospital , Brisbane, QLD, Australia
  7. Starship Children's Hospital , Auckland Hospital , Auckland, New Zealand
  8. Medical Oncology, Austin Hospital, Melbourne, VIC, Australia
  9. Medical Oncology, Auckland Hospital , Auckland, New Zealand
  10. Medical Oncology, Nepean Hospital, Sydney, NSW, Australia
  11. Medical Oncology, Monash University Eastern Health Clinical School, Melbourne, VIC, Australia
  12. Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
  13. Medical Oncology, Chris O'Brien Lifehouse, S, N, Australia


Bleomycin, etoposide, cisplatin (BEP) administered 3-weekly x 4 remains standard first-line chemotherapy for intermediate and poor-risk metastatic GCTs. High-dose chemotherapy and more complex regimens (e.g. VIP, T-BEP) have failed to improve cure-rates. Accelerating regimens of standard chemotherapy by administering them 2-weekly rather than 3-weekly has improved cure-rates in other cancers. 


To determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor-risk metastatic GCTs. 


Open-label, randomised, stratified, 2-arm multicentre, 2-stage, phase-3 clinical trial. Primary endpoint for stage I of the trial (n=150) is complete response rate, and for complete trial (n=500) is progression-free-survival (PFS). Sample size of 150 and 500 patients gives >80% power to detect a 20% improvement in response-rate and 7% absolute improvement in 2-year PFS, respectively.


Male and female participants aged 11-45 years with intermediate or poor-risk metastatic GCTs of testis, ovary, retroperitoneum and mediastinum for first-line chemotherapy. 


Randomisation 1:1 to “standard BEP” or “accelerated BEP” comprising 4 cycles of: cisplatin 20mg/m2 IV days 1-5; etoposide 100mg/m2 IV days 1-5; bleomycin IV weekly; and pegylated G-CSF or filgrastim; given every 3-weeks or every 2-weeks respectively. In the accelerated BEP arm, 4 additional weekly doses of bleomycin follow. 


Initial response assessment at 30-day safety-assessment. Final response assessment at 6-months from randomisation or after all post-chemotherapy intervention is completed. Follow-up 3-monthly for 24-months from randomisation, then 6-monthly for 24-60 months, then annually. Archival tumour-tissue and bloods will be collected for future translational sub-studies. 


25-sites open in ANZ by August 2017, 40-patients recruited. 1/19 sites open in UK by August 2017. International collaborations with Ireland and USA (children and adult groups) confirmed with sites expected to open by late 2017. 

Co-funded by Cancer Council Australia and Cancer Australia. ANZUP supported by Cancer Australia and CINSW. ANZCTR: ACTRN12613000496718.