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 to be confirmed

ANZ Study Chair:

Dr Peter Grimison

ANZ Coordinating Centre:

NHMRC Clinical Trials Centre

Trial Coordinator:

Annie Yeung

Trial Email:

P3bep@ctc.usyd.edu.au

Patient Population:

Patients aged 16 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:

ACT
• Canberra Hospital

NSW
• Border Medical Oncology
• 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
• Box Hill Hospital
• Monash Medical Centre - Moorabin
• Peter MacCallum Cancer Centre
• Sunshine Hospital 

WA
• Fiona Stanley Hospital

NEW ZEALAND
• Auckland Hospital
• Christchurch Hospital
• Dunedin Hospital
• Palmerston North Hospital
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