Phase 3 Accelerated BEP: A Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumors

Purpose

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 tumors.

Detailed Description:

Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumors (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.

Age

18 and under
18 to 65

Gender

N/A

Monetary compensation

No

Can be done from home

No

Keywords

Germ Cell Tumors, Bleomycin, Etoposide, Cisplatin, Pegylated G-CSF

Principal Investigator

William B Slayton, M.D.

Sponsoring Group

Department of Pediatrics

Department

MD-PEDS-HEMATOLOGY

Contact Information

slaytwb@peds.ufl.edu

352.273.9120


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