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  • P3BEP (ANZUP 1302)

    Acronym: 

    ANZUP 1302

    ACTRN/NCT /ethics: 

    NCT02582697

    Scientific title: 

    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

    Summary of trial and patient characteristics

    Cancer Type Other
    Trial Type Treatment
    Phase Phase III Tumour Stream Germ cell
    Age Range 11-45 years Cancer Stage Locally Recurrent or Locally Advanced
    Sex Male Anticipated Start Date 2014-02-01
    Molecular Target Anticipated End Date 2023-07-01
    Cancer Type Other
    Trial Type Treatment
    Phase Phase III
    Age Range 11-45 years
    Sex Male
    Molecular Target
    Tumour Stream Germ cell
    Cancer Stage Locally Recurrent or Locally Advanced
    Anticipated Start Date 2014-02-01
    Anticipated End Date 2023-07-01

    Trial Summary

    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. Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the current gold standard treatment for germ cell tumours, which is a chemotherapy combination called BEP (bleomycin, etoposide and cisplatin) administered on a 3 weekly cycle. BEP is given with a drug called pegfilgrastim which encourages white blood cell production and prevents blood cell complications of chemotherapy. Participants in the other group will receive the same dose of BEP but on a 2 weekly schedule. This is called 'accelerated BEP'. Participants will be regularly assessed for treatment response, side effects and quality of life for a period of up to 2 years. This will enable us to determine whether giving the dose of BEP on a 2 weekly schedule is more effective than a 3 weekly schedule. We will also be able to track whether the shorter schedule causes more, the same, or less side effects.

    Lay Summary

    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

    Sponsor / Cooperative group

    University of Sydney

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Ashford Cancer Centre Research Sue Yeend syeend@adelaidecancercentre.com.au 08 8292 2240 Professor Hsing Tan Recruitment on Hold
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Recruiting
    Royal Adelaide Hospital Anne Milton anne.milton@sa.gov.au 08 7074 2342 Recruiting