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Accelerated versus standard BEP chemotherapy for intermediate and poor‑risk metastatic germ cell tumours

Phase 3 Accelerated BEP: A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours

Phase 3 Interventional University of Sydney · NCT02582697

This trial will test whether giving BEP chemotherapy every 2 weeks instead of every 3 weeks helps males (typically aged 11–50) with intermediate- or poor‑risk metastatic germ cell tumours do better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment500 (estimated)
Ages11 Years to 50 Years
SexAll
SponsorUniversity of Sydney Academic / other
Drugs / interventionschemotherapy
Locations28 sites (New York, New York and 27 other locations)
Trial IDNCT02582697 on ClinicalTrials.gov

What this trial studies

This phase 3, randomized trial compares an accelerated schedule of BEP (bleomycin, etoposide, cisplatin) with standard 3‑weekly BEP as first‑line treatment for intermediate and poor‑risk metastatic germ cell tumours. The accelerated arm gives cisplatin and etoposide every 2 weeks with growth‑factor support (pegfilgrastim/filgrastim) to maintain dose intensity, while the control arm receives the conventional 3‑weekly regimen. Eligible participants have marker‑ or histology‑confirmed metastatic germ cell tumours (including testis, ovary, mediastinum or retroperitoneum) with intermediate or poor prognosis by IGCCC criteria and adequate organ and marrow function. The trial is run across multiple tertiary centers in Australia, New Zealand, Europe and the United States to determine whether the accelerated approach is superior for first‑line cure rates and disease control.

Who should consider this trial

Good fit: Ideal candidates are people (typically males aged 11–50) with histologically or marker‑confirmed intermediate‑ or poor‑risk metastatic germ cell tumours arising in the testis, ovary, mediastinum, or retroperitoneum who have adequate bone marrow, liver and renal function.

Not a fit: Patients with good‑risk disease, those outside the age or organ‑function eligibility criteria, or those who have already received first‑line chemotherapy are unlikely to benefit from enrolling in this trial.

Why it matters

Potential benefit: If successful, accelerated BEP could raise cure rates or reduce relapses for patients with intermediate‑ and poor‑risk metastatic germ cell tumours compared with standard BEP.

How similar studies have performed: Previous attempts to improve first‑line therapy for intermediate and poor‑risk germ cell tumours have generally not increased cure rates and were more toxic, so accelerated BEP is a newer strategy being directly tested in this randomized phase 3 setting.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥ 11 years and ≤ 50 years on the date of randomisation
2. Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or Exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case 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 IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries). (See protocol for more information).
6. Adequate bone marrow function with ANC ≥1.0 x 10\^9/L, Platelet count ≥100 x 10\^9/L
7. Adequate liver function where bilirubin must be ≤1.5 x ULN, except participants with Gilbert's Syndrome where bilirubin must be ≤2.0 x ULN; ALT and AST must be ≤2.5 x ULN, except if the elevations are due to hepatic metastases, in which case ALT and AST must be ≤ 5 x ULN
8. Adequate renal function with estimated creatinine clearance of ≥60 ml/min according to the Cockcroft-Gault formula, unless calculated to be \< 60 ml/min or borderline in which case GFR should be formally measured, eg. with 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 Criteria:

1. Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)
2. Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin or if patient hasb. non-seminoma by IGCCC criteria or stage IV malignant ovarian germ cell tumour in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (eg. organ failure, vena cava obstruction, overwhelming burden of disease). Acceptable regimens include cisplatin 20 mg/m2 days 1-2 and etoposide 100 mg/m2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m2 days 1-2; or baby-BOP.43 Patients must meet all other inclusion and exclusion criteria at the time of registration.

   Additionally participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomisation. Such patients must be discussed with the coordinating centre prior to registration, and must be registered within 10 days of commencing study chemotherapy.
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 ≥ grade 2 or clinically significant sensorineural 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 use 2 effective methods of contraception, including use of a condom, during chemotherapy and for a year after completing chemotherapy.
8. Known allergy or hypersensitivity to any of the study drugs
9. Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse

The above inclusion and exclusion criteria will apply to stage 1 (n=150) and stage 2 (n=500 including stage 1) of the study. All sites will participate in both stages of the study with the exception of the Children's Oncology Group who will be participate in stage 1 only.

Where this trial is running

New York, New York and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Germ Cell TumorGerm CellIntermediate and poor-risk metastatic germ cell tumours
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.