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Can a faster chemo schedule beat tough testicular cancer?

NCT ID NCT02582697

Disease control Sponsor: University of Sydney Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This phase 3 trial compares two schedules of BEP chemotherapy for people with intermediate or poor-risk metastatic germ cell tumors, a type of cancer that often starts in the testicles. The standard schedule gives treatment every 21 days, while the accelerated schedule compresses cycles to 14 days. Researchers want to see if the faster schedule improves progression-free survival, meaning the time before the cancer grows or the patient dies. The trial enrolls about 500 males aged 11 to 50 and measures response by tumor size and blood markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bleomycin and etoposide, given as part of the BEP chemotherapy regimen, with the accelerated arm compressing the treatment schedule from 21-day to 14-day cycles.
What this could lead to
If the accelerated schedule works, it could improve the chance of keeping the cancer from growing or returning in people with harder-to-treat germ cell tumors.
What could go wrong
The trial is still testing the idea, and the accelerated schedule may not be more effective than the standard one. It could also increase side effects, such as lung damage from bleomycin or low blood counts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2014

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

11 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

germ cell tumor Neoplasms, Germ Cell and Embryonal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Germ cell tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    53 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advocate Children's Hospital-Oak Lawn

    RECRUITING

    Oak Lawn, Illinois, United States

  • Advocate Children's Hospital-Park Ridge

    RECRUITING

    Park Ridge, Illinois, United States

  • Ann and Robert H Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, United States

  • Auckland Hospital

    RECRUITING

    Grafton, Auckland, 1142, New Zealand

  • Austin Health

    RECRUITING

    Heidelberg, Victoria, 3084, Australia

  • Beatson West of Scotland Cancer Centre

    RECRUITING

    Glasgow, Scotland, United Kingdom

  • Belfast City Hospital

    RECRUITING

    Belfast, Northern Ireland, United Kingdom

  • Border Medical Oncology

    RECRUITING

    Wodonga, Victoria, 3690, Australia

  • Box Hill Hospital

    RECRUITING

    Box Hill, Victoria, 3128, Australia

  • Calvary Mater Newcastle

    RECRUITING

    Newcastle, New South Wales, 2298, Australia

  • Cambridge University Hosptial

    RECRUITING

    Cambridge, England, United Kingdom

  • Chris O'Brien Lifehouse

    RECRUITING

    Sydney, New South Wales, 2050, Australia

  • Christchurch Hospital

    RECRUITING

    Christchurch, 8011, New Zealand

  • Concord Repatriation General Hospital

    RECRUITING

    Sydney, New South Wales, 2139, Australia

  • Dana-Farber/Harvard Cancer Center

    RECRUITING

    Boston, Massachusetts, United States

  • Driscoll Children's Hospital

    RECRUITING

    Corpus Christi, Texas, United States

  • Dunedin Hospital

    WITHDRAWN

    Dunedin, 9054, New Zealand

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, Western Australia, 6847, Australia

  • Flinders Medical Centre

    ACTIVE_NOT_RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    RECRUITING

    Baltimore, Maryland, United States

  • Kaiser Permanente Downey Medical Center

    RECRUITING

    Downey, California, United States

  • Loma Linda University Medical Center

    RECRUITING

    Loma Linda, California, United States

  • Los Angeles General Medical Center

    RECRUITING

    Los Angeles, California, United States

  • Lucile Packard Children's Hospital Stanford University

    RECRUITING

    Palo Alto, California, United States

  • Macquarie Cancer Clinical Trials

    RECRUITING

    Sydney, New South Wales, 2109, Australia

  • Memorial Sloan Kettering Cancer Centre

    RECRUITING

    New York, New York, 10065, United States

  • Miller Children's and Women's Hospital Long Beach

    RECRUITING

    Long Beach, California, United States

  • Nepean Hospital

    RECRUITING

    Sydney, New South Wales, 2751, Australia

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, United States

  • Palmerston North Hospital

    RECRUITING

    Roslyn, Palmerston North, 4442, New Zealand

  • Peter MacCallum Cancer Centre

    RECRUITING

    East Melbourne, Victoria, 3002, Australia

  • Primary Children's Hospital

    RECRUITING

    Salt Lake City, Utah, United States

  • Prince of Wales Hospital

    RECRUITING

    Sydney, New South Wales, 2031, Australia

  • Princess Alexandra

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Queensland Children's Hospital

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Rady Children's Hospital - San Diego

    RECRUITING

    San Diego, California, United States

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Royal Brisbane & Women's Hospital

    RECRUITING

    Brisbane, Queensland, 4029, Australia

  • Royal Hobart Hospital

    RECRUITING

    Hobart, Tasmania, 7000, Australia

  • Royal North Shore Hospital

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • Royal Preston Hospital, Lancashire

    RECRUITING

    Lancaster, England, United Kingdom

  • SAN Clinical Trials Unit

    RECRUITING

    Wahroonga, New South Wales, 2076, Australia

  • St Bartholomew's Hospital

    RECRUITING

    London, England, United Kingdom

  • St James's University Hospital, Leeds

    RECRUITING

    Leeds, West Yorkshire, United Kingdom

  • Stanford Cancer Institute Palo Alto

    RECRUITING

    Palo Alto, California, United States

  • Starship Children's Hospital

    RECRUITING

    Grafton, Auckland, 1023, New Zealand

  • Sunshine Hospital

    WITHDRAWN

    St Albans, Victoria, 3021, Australia

  • The Royal Marsden Hospital

    RECRUITING

    London, England, United Kingdom

  • USC / Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    RECRUITING

    Dallas, Texas, 75235, United States

  • University College Hospital, London

    RECRUITING

    London, England, United Kingdom

  • University Hospital Southampton

    RECRUITING

    Southampton, England, United Kingdom

  • University of Illinois

    RECRUITING

    Chicago, Illinois, United States

  • University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, United States

  • Velindre Hospital

    RECRUITING

    Cardiff, South East Wales, United Kingdom

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, United States

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