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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official 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

Brief 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.

Detailed Summary: Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). Cure rates are over 90% for good-risk disease, 85% with intermediate-risk, and about 70% for poor-risk disease. Previous strategies to improve first-line chemotherapy have failed to improve cure rates and were more toxic than BEP. New strategies are needed for patients with intermediate and poor-risk disease. BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) is conducting a trial comparing accelerated BEP with standard BEP. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.
Sponsor: University of Sydney

Current Primary Outcome: Progression-free survival (disease progression or death) [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Initial response assessment [ Time Frame: At end of chemotherapy treatment, treatment planned for 12 weeks ]
    The assessment of response of germ cell tumours is measured by the change in size of measurable tumour masses in combination with changes in serum tumour markers after chemotherapy treatment.
  • Final response assessment [ Time Frame: At 6 months ]
    The assessment of response of germ cell tumours is measured by changes in serum tumour markers and imaging at 6 months from randomisation, or after any post-chemotherapy surgical resection or other intervention, whichever occurs last.
  • Adverse events (worst grade according to NCI CTCAE v4.03) [ Time Frame: From start of chemotherapy until 30 days after last dose, an average of 4 months ]
    The intensity of adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE v4.03)
  • Health-related quality of life [ Time Frame: From date of randomisation until date of 18 month follow-up ]
    HR-QoL measures will include the EORTC core quality of life questionnaire (QLQ-C30), a 30-item cancer-specific questionnaire that is well-validated and available in many languages.
  • Health-related quality of life for testicular cancer [ Time Frame: From date of randomisation until date of 18 month follow-up ]
    EORTC quality of life module for testicular cancer (QLQ-TC26), a disease-specific measure with 26 items about physical symptoms, sexual functioning and emotional issues.
  • Treatment preference [ Time Frame: From date of randomisation until date of 18 month follow-up ]
    A trial-specific preferences question will be used to determine if participants think they would prefer to be treated with accelerated BEP or standard BEP, assuming that they were equally effective.
  • Delivered dose-intensity of chemotherapy (relative to standard BEP) [ Time Frame: From start date of chemotherapy treatment until date of end of chemotherapy, an average of 12 weeks ]
    Delivered dose-intensity of cisplatin, etoposide and bleomycin will be assessed.
  • Overall survival [ Time Frame: From randomisation up to disease progression or date of death whichever come first, assessed up to 5 years ]
    Overall survival is measured from the date of randomisation until death from any cause, or the date of last known follow-up alive.


Original Secondary Outcome: Same as current

Information By: University of Sydney

Dates:
Date Received: September 7, 2015
Date Started: February 2014
Date Completion: July 2023
Last Updated: May 11, 2016
Last Verified: May 2016