Actively Recruiting
Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
Led by University of Sydney · Updated on 2025-06-15
500
Participants Needed
28
Research Sites
830 weeks
Total Duration
On this page
Sponsors
U
University of Sydney
Lead Sponsor
A
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.
CONDITIONS
Official Title
Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 11 and 50 years at randomisation
- Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma), or very high tumour markers with typical metastatic pattern
- Primary tumour arising in testis, ovary, retro-peritoneum, or mediastinum
- Metastatic disease or non-testicular primary tumour
- Intermediate or poor prognosis according to IGCCC classification
- Adequate bone marrow function with ANC ≥ 1.0 x 10^9/L and platelet count ≥ 100 x 10^9/L
- Adequate liver function with bilirubin ≤ 1.5 x ULN (or ≤ 2.0 x ULN with Gilbert's Syndrome), ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN if due to liver metastases)
- Adequate renal function with creatinine clearance ≥ 60 ml/min (or GFR measured if borderline)
- ECOG Performance Status of 0, 1, 2, or 3
- Planned and able to start study treatment within 14 days of randomisation
- Willing and able to comply with all study requirements, including assessments
- Able to provide signed, written informed consent
You will not qualify if you...
- Other primary malignancy except treated non-melanomatous skin carcinoma, germ cell tumour, or other malignancy treated over 5 years ago with no recurrence
- Previous chemotherapy or radiotherapy except certain cases of low-dose induction chemotherapy or adjuvant therapy for seminoma
- Significant cardiac disease preventing IV fluid hydration for cisplatin
- Significant respiratory disease contraindicating bleomycin use
- Peripheral neuropathy grade 2 or higher, or significant hearing loss or tinnitus
- Severe concurrent illness or infection that would affect safety
- Inadequate contraception; men must use two effective methods including condom during and for one year after chemotherapy
- Known allergy or hypersensitivity to any study drugs
- Any psychological, familial, social, or geographical condition that may affect study compliance, including alcohol dependence or drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
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
Research Team
P
P3BEP Trial Coordinator
CONTACT
P
P3BEP Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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