P3BEP

Trial Title:

Accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours: a randomised phase III trial

Trial Acronym:

Phase III Accelerated BEP Trial

Protocol Number:

ANZUP 1302

Trial Design:

Open-label, randomised, two-arm, multicentre, phase III clinical trial

Collaborators:

UK and US sites

ANZ Study Chair:

Peter Grimison

ANZ Coordinating Centre:

NHMRC Clinical Trials Centre

Trial Coordinator:

Annie Yeung

Trial Email:

P3bep@ctc.usyd.edu.au


Recruitment Aim: 

Stage 1: 150 patients
Stage 2: 350 patients

Patient Population:

Patients aged 11 to 45 years with intermediate or poor-risk advanced germ cell tumours requiring first-line chemotherapy

Intervention:

The only difference between accelerated BEP and standard BEP is that cisplatin & etoposide are cycled 2-weekly rather than 3-weekly.

Primary Outcome:

To compare progression-free survival amongst patients randomised to accelerated BEP or standard BEP. 

Secondary Outcomes:

To compare:
1. Overall survival
2. 12-month continuous complete remission rates
3. Favourable response rates
4. Adverse events
5. Health-related quality of life
6. Delivered dose-intensity of chemotherapy

Status:

Active and Recruiting

Sites Recruiting:

NSW
• Calvary Mater Newcastle
• Chris O'Brien Lifehouse
• Concord Repatriation General Hospital
• Macquarie Cancer Clinical Trials
• Nepean Hospital
• Prince of Wales Hospital
• Royal North Shore Hospital
• SAN Clinical Trials Unit
• The Tweed Hospital
• Westmead Hospital

QLD
• Princess Alexandra Hospital
• Royal Brisbane & Women’s Hospital

SA
• Flinders Medical Centre
• Royal Adelaide Hospital

TAS
• Royal Hobart Hospital

VIC
• Austin Health
• Border Medical Oncology
• Box Hill Hospital
• Peter MacCallum Cancer Centre
• Sunshine Hospital 

WA
• Fiona Stanley Hospital

NEW ZEALAND
• Auckland Hospital
• Christchurch Hospital
• Dunedin Hospital
• Palmerston North Hospital
• Starship Children's Hospital

UK
• Addenbrooke's Hospital
• Royal Preston Hospital
• Beatson West of Scotland Cancer Centre
• Bristol University Hospital 
• Velindre Hospital 
• Cambridge University Hospital Paediatric 
• University Hospital Southhampton 
• Royal Marsden Hospital  
• St James Hospital - Leeds 

USA
• Saint Mary's Hospital, West Palm Beach
• Sinai Hospital of Baltimore 
• Toledo Children's Hospital 
• Washington University School of Medicine, St Louis 
• Dana-Faber Cancer Institute 
• Rady Children's Hospital  
• University Of Colorado  
• Indiana University Hospital  
• Cincinnati Children's Hospital
• Loma Linda University Cancer Centre 
• University of Southern California 
• Fred Hutchinson Cancer Research Centre  
• Arkansas Children's Hospital   
• Joe DiMaggio Cancer Centre   
• Nemours Children's Clinic  
• Augusta University Medical Centre
• Vanderbilt University Medical Centre    

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