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RecruitingLast updated: 30 April 2026

P3BEP: Is an accelerated two-week treatment with BEP chemotherapy as effective as receiving the standard three-week cycle, for patients with metastatic germ cell tumours?Phase 3 Accelerated BEP Trial: A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People16 - 45

Trial acronym

P3BEP

Clinical summary

Summary

The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males and females with intermediate and poor-risk metastatic germ cell tumours.

Who is it for?
People aged 11 years to 45 years old who have been diagnosed with metastatic germ cell tumour/s in the testes, ovary, retro-peritoneum or mediastineum and considering first-line chemotherapy.

Study details
Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the current gold standard treatment for germ cell tumours, which is a chemotherapy combination called BEP (bleomycin, etoposide and cisplatin) administered on a 3 weekly cycle. BEP is given with a drug called pegfilgrastim which encourages white blood cell production and prevents blood cell complications of chemotherapy. Participants in the other group will receive the same dose of BEP but on a 2 weekly schedule. This is called 'accelerated BEP'.

Participants will be regularly assessed for treatment response, side effects and quality of life for a period of up to 2 years. This will enable us to determine whether giving the dose of BEP on a 2 weekly schedule is more effective than a 3 weekly schedule. We will also be able to track whether the shorter schedule causes more, the same, or less side effects. 

http://www.anzup.org.au/content.aspx?page=trials-p3bep

Conditions

This trial is treating people with germ cell tumours

Eligibility

Inclusion

1. Age greater than or equal to 11 years and less than or equal to 45 years on the date of randomisation
2. Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma), except in the rare case of exceptionally raised tumour markers (AFP greater than or equal to 1000ng/mL and/or beta-HCG greater than or equal to 5000 IU/L) without histologic or cytologic confirmation where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently
3. Primary arising in testis, ovary, retro-peritoneum, or mediastinum
4. Metastatic disease or non-testicular primary
5. Intermediate or poor prognosis as defined by modified IGCCC classification (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries).
6. Adequate bone marrow function with ANC greater than or equal to 1.0 x 10^9/L, Platelet count greater than or equal to 100 x 10^9/L
7. Adequate liver function where bilirubin must be less than or equal to 1.5 x ULN, ALT and AST must be less than or equal to 2.5 x ULN; except if the elevations are due to hepatic metastases, in which case ALT and AST must be less than or equal to 5 x ULN
8. Adequate renal function of GFR greater than or equal to 60 ml/min. It is recommended that GFR is estimated with the Cockcroft-Gault formula, unless calculated to be less than 60 ml/min or borderline in which case by EDTA scan
9. ECOG Performance Status of 0, 1, 2, or 3
10. Study treatment both planned and able to start within 14 days of randomisation.
11. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments
12. Able to provide signed, written informed consent

Exclusion

1. History of a malignancy prior to registration except for germ cell tumour or non-melanomatous carcinoma of the skin
2. Previous chemotherapy or radiotherapy, except (a)participants with pure seminoma relapsing after radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin, (b)participants with NSGCT and poor prognosis by IGCCC criteria receiving pre-protocol chemotherapy (eg. low-dose platinum and etoposide, baby-BOP) , (c)Participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomisation.
3. Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
4. Significant co-morbid respiratory disease that contraindicates the use of Bleomycin
5. Peripheral neuropathy greater than or equal to grade 2 or clinically significant sensori-neural hearing loss or tinnitus
6. Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
7. Inadequate contraception. Men must have been surgically sterilised or use a double barrier method of contraception
8. Known allergy or hypersensitivity to any of the study drugs
9. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ANZCTR, ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)

Scientific Title

Phase 3 Accelerated BEP Trial: A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours

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