Meeting
2018 Genitourinary Cancers Symposium
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).
Authors
Namrata Nayar
NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia
Namrata Nayar , 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 , Peter S. Grimison
Organizations
NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia, Sydney Catalyst Translational Cancer Research Centre, Sydney, Australia, Prince of Wales Hospital, Randwick, Australia, Addenbrooke's Hospital, Cambridge, United Kingdom, Yale Cancer Center, Yale School of Medicine, New Haven, CT, USC Keck School of Medicine 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, Victoria, Australia, Peter MacCallum Cancer Centre, Melbourne, Australia, Chris O'Brien Lifehouse, Sydney, 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 days (D) 1-5; etoposide 100mg/m2 IV D1-5; bleomycin 30000 IU IV (D 1, 8, 15 or D 2, 9, 16 of a 21 day cycle; D 1, 8 or D 2, 9 of a 14 day cycle); and peg G-CSF or Filgrastim; 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, 1/19 sites open in UK (led by Cambridge Clinical Trials Unit), 41 patients recruited by September 2017. International collaborations with USA (led by Children’s Oncology Group) and Ireland (led by Cancer Trials Ireland) confirmed with sites expected to open by late 2017 and more sites sought for stage 2. Clinical trial information: NCT02582697
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Abstract Details
Session Type
Trials in Progress Poster Session
Session Title
Trials in Progress Poster Session B: Prostate Cancer, Urothelial Carcinoma, and Penile, Urethral and Testicular Cancers
Track
Urothelial Carcinoma,Prostate Cancer,Penile, Urethral, and Testicular Cancers
Sub Track
Penile, Urethral, and Testicular Cancers
Clinical Trial Registration Number
NCT02582697
Citation
J Clin Oncol 36, 2018 (suppl 6S; abstr TPS574)
DOI
10.1200/JCO.2018.36.6_suppl.TPS574
Abstract #
TPS574
Poster Bd #
P2
Abstract Disclosures
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