Actively Recruiting
Led by University of Sydney · Updated on 2025-06-15
500
Participants Needed
28
Research Sites
N/A
Total Duration
U
University of Sydney
Lead Sponsor
A
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Collaborating Sponsor
Researchers are evaluating whether accelerated BEP chemotherapy is more effective than the standard BEP regimen for males aged 11 to 50 years with intermediate and poor-risk metastatic germ cell tumors. This phase 3 randomized trial aims to improve cure rates for these patients, as current treatments have limited success for higher-risk disease. The study is led by the University of Sydney and focuses on first-line chemotherapy outcomes for metastatic germ cell tumors. The study compares two treatment schedules: standard BEP chemotherapy given every 3 weeks for 4 cycles, and accelerated BEP given every 2 weeks for 4 cycles followed by additional bleomycin doses. Both regimens include bleomycin, etoposide, cisplatin, and supportive growth factors like pegylated G-CSF or filgrastim, with dosing adjusted by age and weight. Treatment lasts about 12 weeks in both arms. Participants will undergo treatment cycles with regular intravenous chemotherapy infusions and weekly bleomycin doses. Researchers will assess progression-free survival up to 5 years after randomization, along with tumor response at the end of treatment and at 6 months. Safety will be monitored through adverse events, and quality of life will be measured up to 18 months. Overall survival and chemotherapy dose intensity are also tracked. The study involves multiple assessments and follow-up visits to monitor effects and outcomes.
CONDITIONS
Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive 4 cycles of chemotherapy using either accelerated or standard BEP regimen. Treatment cycles occur every 2 weeks for the accelerated arm or every 3 weeks for the standard arm. Additional bleomycin doses are given in the accelerated arm after the 4 cycles.
Weekly visits during chemotherapy cycles
Duration - Up to 5 years
Participants are monitored after the end of chemotherapy treatment for assessment of response, adverse events, and overall survival.
Periodic visits for assessments up to 5 years
Total: 28 locations
1
Memorial Sloan Kettering Cancer Centre
New York, New York, United States, 10065
Actively Recruiting
2
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Actively Recruiting
3
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
4
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2031
Actively Recruiting
5
Chris O'Brien Lifehouse
Sydney, New South Wales, Australia, 2050
Actively Recruiting
6
Macquarie Cancer Clinical Trials
Sydney, New South Wales, Australia, 2109
Actively Recruiting
7
Concord Repatriation General Hospital
Sydney, New South Wales, Australia, 2139
Actively Recruiting
8
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Withdrawn
9
Nepean Hospital
Sydney, New South Wales, Australia, 2751
Actively Recruiting
10
Tweed Hospital
Tweed Heads, New South Wales, Australia, 2485
Actively Recruiting
11
SAN Clinical Trials Unit
Wahroonga, New South Wales, Australia, 2076
Actively Recruiting
12
Royal Brisbane & Women's Hospital
Brisbane, Queensland, Australia, 4029
Actively Recruiting
13
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
14
Princess Alexandra
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
15
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
16
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Active, Not Recruiting
17
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Actively Recruiting
18
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Actively Recruiting
19
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Actively Recruiting
20
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
21
Sunshine Hospital
St Albans, Victoria, Australia, 3021
Withdrawn
22
Border Medical Oncology
Wodonga, Victoria, Australia, 3690
Actively Recruiting
23
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6847
Actively Recruiting
24
Starship Children's Hospital
Grafton, Auckland, New Zealand, 1023
Actively Recruiting
25
Auckland Hospital
Grafton, Auckland, New Zealand, 1142
Actively Recruiting
26
Palmerston North Hospital
Roslyn, Palmerston North, New Zealand, 4442
Actively Recruiting
27
Christchurch Hospital
Christchurch, New Zealand, 8011
Actively Recruiting
28
Dunedin Hospital
Dunedin, New Zealand, 9054
Withdrawn
P
P3BEP Trial Coordinator
P
P3BEP Project Manager
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Nicola J Lawrence, Howard Chan, Guy Toner...
https://pubmed.ncbi.nlm.nih.gov/30157803