Phase 3 Accelerated BEP Trial: A Randomised Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumours (P3BEP Trial)

Protocol No
COG-ALLIANCE-AGCT1532-P3BEP
Principal Investigator
John Burfeind
Phase
III
Summary
Standard treatment for advanced germ cell tumors includes three chemotherapy drugs called BEP (Bleomycin, Etoposide, and cisPlatin). BEP is given with a drug called pegfilgrastim or filgrastim which makes white blood cells grow. These drugs are given over the course of 3 weeks. Previous research has been done in studying BEP to improve the outcome of patients with poor-risk GCTs. One method that was tried is called dose intensification. This method works by giving the dose of chemotherapy drugs over a shorter length of time. Instead of the standard 3 week-cycle, patients would receive their treatment in a 2 week-cycle. By giving the drugs on a faster, or "accelerated" schedule, the study researchers wanted to see if this would help patients with poor-risk GCTs. The patients on the accelerated therapy in these previous studies did not experience more side effects than would be expected for standard BEP. This study will compare the standard chemotherapy regimen with an accelerated chemotherapy regimen using the same drugs to see if the accelerated chemotherapy regimen is beneficial but not more toxic than the standard chemotherapy regimen. The accelerated chemotherapy is experimental. The overall goal of this study is to determine whether accelerated BEP will be effective and well-tolerated for patients with advanced GCTs. We don't yet know if accelerated treatment is helpful in advanced GCTs and we are hoping this study will answer that question.
Description
A Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastatic Germ Cell Tumors
Participating Institutions
Children's Wisconsin
Froedtert Hospital
Status
ON HOLD
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