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).

Authors

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Peter S. Grimison

Chris O'Brien Lifehouse, Sydney, Australia

Peter S. Grimison , Nicola Jane Lawrence , Martin R. Stockler , Andrew James Martin , Sonia Yip , Nicole Wong , Annie Yeung , Michael Friedlander , Danish Mazhar , Farzana Pashankar , David I. Quinn , Ray McDermott , Rick Walker , Mark Winstanley , Fritha J. Hanning , Andrew James Weickhardt , Amanda Gwendolyn Stevanovic , Ian D. Davis , Guy C. Toner

Organizations

Chris O'Brien Lifehouse, Sydney, Australia, NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia, NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia, NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, Australia, Prince of Wales Hospital, Randwick, Australia, Addenbrooke's Hospital, Cambridge, United Kingdom, Yale Cancer Center, Yale School of Medicine, New Haven, CT, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, Cancer Trials Ireland, Dublin, Ireland, Australian and New Zealand Children's Haematology/Oncology Group, Brisbane, Australia, Starship Hospital, Auckland, New Zealand, Auckland City Hospital, Auckland, New Zealand, Olivia Newton-John Cancer Wellness and Research Centre, Melbourne, Australia, Nepean Cancer Care Centre, Kingswood, Australia, Monash University Eastern Health Clinical School, Melbourne, Australia, Department of Medical Oncology, Peter MacCallum Cancer Centre, Australia, Melbourne, Australia

Research Funding

Other

Background: Bleomycin, etoposide, cisplatin (BEP) given 3-weekly x 4 remains standard 1st line chemotherapy for metastatic GCTs. Acceleration of standard regimen with shorter cycle lengths has improved cure rates in other cancers. This is the first international randomised clinical trial for intermediate and poor-risk metastatic extracranial GCTs involving both adult and paediatric age group males and females. We aim to determine if accelerated BEP is superior to standard BEP. Methods: DESIGN: Open label, randomised, stratified multicentre, 2 stage, phase 3 trial. Primary endpoint for stage I (n = 150) is complete response rate (RR), and for entire trial (n = 500) is progression free survival (PFS). SAMPLE SIZE: 150 and 500 patients gives > 80% power to detect a 20% improvement in RR and 7% absolute improvement in 2yr PFS, respectively. POPULATION: Males and females aged 11-45 years with intermediate or poor-risk metastatic GCTs of the testis, ovary, retroperitoneum or mediastinum for 1st line chemotherapy. TREATMENT: Randomisation 1:1 to 4 cycles of “standard BEP” or “accelerated BEP”: cisplatin 20mg/m2 IV D1-5; etoposide 100mg/m2 IV D1-5; bleomycin 30000 IU IV weekly; and pegylated G-CSF SC D6 or Filgrastim daily; given every 3 weeks or every 2 weeks respectively. Accelerated BEP arm receives 4 additional weekly doses of bleomycin. ASSESSMENTS: Response assessments at 30 day safety assessment, and 6 months from randomisation or after all post-chemotherapy intervention is completed. Regular follow-up up to 5 years, then annually. Archival tumour tissue and baseline blood collected for translational substudies. STATUS: 25 sites open in ANZ, 4/21 sites open in UK (led by Cambridge Clinical Trials Unit), 46 patients recruited by February 2018. International collaboration with USA (led by Children’s Oncology Group) is confirmed with sites expected to open by mid2018 and more sites sought for stage 2. Clinical trial information: NCT02582697

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Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary (Nonprostate) Cancer

Track

Genitourinary Cancer—Kidney and Bladder

Sub Track

Germ Cell/Testicular

Clinical Trial Registration Number

NCT02582697

Citation

J Clin Oncol 36, 2018 (suppl; abstr TPS4596)

DOI

10.1200/JCO.2018.36.15_suppl.TPS4596

Abstract #

TPS4596

Poster Bd #

417a

Abstract Disclosures