Accelerated vs. Standard Chemotherapy for Metastatic Germ Cell Tumors

This study is comparing two ways of giving chemotherapy for metastatic germ cell tumors (a type of cancer that starts in reproductive cells). It's testing if an "accelerated" schedule of Bleomycin, Etoposide, and Cisplatin, along with Pegylated G-CSF or Filgrastim (medications to help with side effects), works better than the standard schedule. The study aims to enroll 500 patients aged 11 to 50 years old who have intermediate or poor-risk metastatic germ cell tumors. Researchers will measure how long patients live without their disease getting worse or until death, for up to 5 years. The current status of this study is unclear.

Study design
This interventional study plans to enroll 500 participants and compares two different chemotherapy schedules.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival (time until disease progression or death) will be assessed for up to 5 years.

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NCT02582697

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

Recruiting
PHASE3Ages 11–50InterventionalTreatment
University of Sydney
~500 participants
Updated 2025-06-15 on ClinicalTrials.gov
What's tested:Bleomycin (active name: Bleomycin Sulfate)EtoposideCisplatinPegylated G-CSF (Pegfilgrastim)Filgrastim

At a glance

Recruiting sites
24 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (disease progression or death)
Measured over From randomisation up to disease progression or date of death whichever come first, assessed up to 5 years
Germ Cell Tumor
28 sites across 10 states
New South Wales10
Victoria5
Queensland3
South Australia2
Auckland2
New Zealand2
New York1
Tasmania1
  • Peter Grimison · STUDY_CHAIR · Chris O'Brien Lifehouse

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  • Progression-free survival (disease progression or death)From randomisation up to disease progression or date of death whichever come first, assessed up to 5 years

    PFS is measured from the date of randomisation until the criteria for disease progression are met (as defined in the protocol) or death. Participants who are not observed to progress nor die will be censored at the date of last follow-up