🏛️ Verified NIH Record • Updated 2025-06-11

Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours (NCT02582697)

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

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: University of Sydney

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (10 items).

Location: Memorial Sloan Kettering Cancer Centre — New York, New York

Age range: 11 Years to 50 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • 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)
  • 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.
  • Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
  • Significant co-morbid respiratory disease that contraindicates the use of bleomycin
  • Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus
  • Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
  • Inadequate contraception. Men must use 2 effective methods of contraception, including use of a condom, during chemotherapy and for a year after completing chemotherapy.
  • Known allergy or hypersensitivity to any of the study drugs
  • 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (28 Sites)

Showing the first 25 of 28 sites.

  • Memorial Sloan Kettering Cancer Centre — New York, New York
  • Calvary Mater Newcastle — Newcastle, New South Wales
  • Royal North Shore Hospital — St Leonards, New South Wales
  • Prince of Wales Hospital — Sydney, New South Wales
  • Chris O'Brien Lifehouse — Sydney, New South Wales
  • Macquarie Cancer Clinical Trials — Sydney, New South Wales
  • Concord Repatriation General Hospital — Sydney, New South Wales
  • Westmead Hospital — Sydney, New South Wales
  • Nepean Hospital — Sydney, New South Wales
  • Tweed Hospital — Tweed Heads, New South Wales
  • SAN Clinical Trials Unit — Wahroonga, New South Wales
  • Royal Brisbane & Women's Hospital — Brisbane, Queensland
  • Queensland Children's Hospital — South Brisbane, Queensland
  • Princess Alexandra — Woolloongabba, Queensland
  • Royal Adelaide Hospital — Adelaide, South Australia
  • Flinders Medical Centre — Bedford Park, South Australia
  • Royal Hobart Hospital — Hobart, Tasmania
  • Box Hill Hospital — Box Hill, Victoria
  • Peter MacCallum Cancer Centre — East Melbourne, Victoria
  • Austin Health — Heidelberg, Victoria
  • Sunshine Hospital — St Albans, Victoria
  • Border Medical Oncology — Wodonga, Victoria
  • Fiona Stanley Hospital — Murdoch, Western Australia
  • Starship Children's Hospital — Grafton, Auckland
  • Auckland Hospital — Grafton, Auckland

📞 Contact the Study Coordinator

Phone: (619) 562-5000

Email: p3bep@ctc.usyd.edu.au

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗