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 ]
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