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

Study acronym: P3BEP
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Trial sites expanded: 28 → 56 locationsv9
  2. Primary completion date: Feb 2022 to Dec 31, 2029
    • Study completion date: Jul 2023 to Dec 31, 2029
    • Eligibility criteria expanded, about 2 words
    v8
  3. Study sites: 25 to 28v7
  4. Re-verified, no change to tracked fieldsv6
  5. Eligibility criteria expanded, about 48 wordsv5
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  1. Study sites: 26 to 25v4
  2. Study sites: 27 to 26
    • Interventions: Bleomycin (active name: Bleomycin Sulfate) (Drug), Cisplatin (Drug), Etoposide (Drug), Pegylated G-CSF (Pegfilgrastim) (Drug) to Bleomycin (active name: Bleomycin Sulfate) (Drug), Cisplatin (Drug), Etoposide (Drug), Filgrastim (Drug), Pegylated G-CSF (Pegfilgrastim)…
    • Eligibility criteria shortened, about 2 words
    v3
  3. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02582697
Lead Sponsor University of Sydney
Collaborators: Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Cambridge University Hospitals NHS Foundation Trust, Cancer Trials Ireland, Children's Oncology Group, Dana-Farber Cancer Institute, University of Southern California
Conditions
(from sponsor)		 Germ Cell Tumor
Related terms Neoplasms, Germ Cell and Embryonal
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov