HIPAA Compliant
ISO 27001 CertifiedActively Recruiting
Led by University of Sydney · Updated on 2025-06-15
500
Participants Needed
28
Research Sites
N/A
Total Duration
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
P
P3BEP Trial Coordinator
P
P3BEP Project Manager
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
University of Sydney
Lead Sponsor
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Accelerated BEP | Standard BEP (trial) | Standard BEP (current care) |
|---|---|---|---|
| What it is | BEP chemotherapy given on a 14‑day cycle (accelerated schedule) with additional weekly bleomycin after the 4 cycles | BEP chemotherapy given on a conventional 21‑day cycle for 4 cycles | BEP administered every 21 days for 4 cycles is the established first‑line chemotherapy for intermediate and poor‑risk metastatic germ cell tumours |
| Role in the trial | Investigational treatment arm testing accelerated schedule | Control arm using the conventional schedule | Reflects routine current‑care chemotherapy schedule outside the study |
| Primary use | First‑line chemotherapy aiming to improve progression‑free survival in intermediate and poor‑risk metastatic germ cell tumours | First‑line chemotherapy serving as comparator for efficacy of accelerated schedule | Standard first‑line chemotherapy used in clinical practice for this patient population |
| How it is given | Bleomycin, etoposide and cisplatin delivered every 14 days for four cycles, followed by weekly bleomycin | Same drugs delivered every 21 days for four cycles | BEP regimen delivered every 21 days for four cycles as per conventional practice |
| Evidence status | Efficacy is being assessed in this randomized trial; evidence pending | Efficacy compared within the trial to assess relative outcomes | Standard BEP regimen is supported by existing clinical consensus as first‑line therapy |
| Risks | Risks associated with BEP chemotherapy (e.g., bleomycin‑related pulmonary toxicity, cisplatin nephrotoxicity, etoposide myelosuppression) apply; accelerated schedule safety still under study | Standard BEP safety profile as known from prior practice (e.g., pulmonary, renal, hematologic risks) | Safety profile established through long‑standing use in clinical practice |
| Important limitations | Effectiveness and safety of the accelerated schedule are not yet established and remain under investigation | Comparator reflects standard care but trial results may not generalize beyond trial‑specific eligibility and scheduling adherence | May not capture modifications used in individual patient cases (e.g., bleomycin omission for lung risk) |
| Patient impact | Pending outcomes from trial; potential for shorter treatment intervals but impact on survival or quality‑of‑life not yet known | Provides established baseline for survival and tolerability based on conventional BEP schedule | Outcomes from long‑standing standard BEP inform expectations for treatment effectiveness and side‑effect management |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Nicola J Lawrence, Howard Chan, Guy Toner...
https://pubmed.ncbi.nlm.nih.gov/30157803/University of Sydney
Lead Sponsor
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Collaborating Sponsor
