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:

A/Prof Peter Grimison

ANZ Coordinating Centre:

NHMRC Clinical Trials Centre

Trial Coordinator:

Evan Buck

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 Trial
Nepean Hospital
Northern NSW Local Health District - The Tweed Hospital
Princes of Wales
Royal North Shore Hospital
Sydney Adventist Hospital

QLD
Princess Alexandra
Queensland Childrens Hospital
Royal Brisbane & Womens Hospital

VIC
Austin Health
Border Medical Oncology
Eastern Health
Peter MacCallum Cancer Centre

SA
Flinders Medical Centre
Royal Adelaide Hospital

WA
Fiona Stanley Hospital

TAS
Royal Hobart Hospital

NEW ZEALAND
Auckland Hospital 
Christchurch Hospital
Palmerston North Hospital 
Starship Hospital –Paediatric 

UK
Royal Preston Hospital
Beatson West of Scotland Cancer Centre
Bristol University Hospital 
Velindre Hospital
Cambridge University Hospital Paediatric
University Hospital Southampton
Royal Marsden Hospital
St James Hospital - Leeds
St Bartholomews Hospital
Nottingham University Hospital 
Belfast City Hospital 
Derriford Hospital, Plymouth 

USA
Washington University School of Medicine
Rady Children’s Hospital
Augusta University Medical Centre
Vanderbilt University Medical Centre
Lucile Packard Children's Hospital Stanford
Memorial Health University Medical Centre
University of Mississippi Medical Centre
Geisinger Medical Center
Palmetto Health Richland 
Methodist Children’s Hospital of South Texas 
University of Wisconsin Hospital 
East Tennessee Children's Hospital
Miller Children's and Women's Hospital Long Beach
Roswell Park Cancer Center
USC / Norris Comprehensive Cancer Care 
Broward HealthCare 
Dana Farber Cancer Center 
UT Southwestern Simmons Cancer Center
LA Biomedical Research Institute at Harbor- UCLA
Dayton Children’s Hospital
University of Texas Science Center at San Antonio
Mayo Clinic
Advocate Children’s Hospital – Oak Lawn
Carolinas Medical Center
USC/ Norris Comprehensive Cancer Care

Further Information: Click Here
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