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

Phase 3 Recruiting 500 enrolled University of Sydney Australian and New Zealand Urogenital and Prostate Cancer Trials Group · collab Cambridge University Hospitals NHS Foundation Trust · collab Cancer Trials Ireland · collab Children's Oncology Group · collab Dana-Farber Cancer Institute · collab University of Southern California · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2014-02
Primary completion: 2029-12-31
Completion: 2029-12-31

Publications

Lawrence NJ, Chan H, Toner G, Stockler MR, Martin A, Yip S, Wong N, Yeung A, Mazhar D, Pashankar F, Frazier L, McDermott R, Walker R, Tan H, Davis ID, Grimison P; ANZUP. Protocol for the P3BEP trial (ANZUP 1302): an international randomised phase 3 trial of accelerated versus standard BEP chemotherapy for adult and paediatric male and female patients with intermediate and poor-risk metastatic germ cell tumours. BMC Cancer. 2018 Aug 29;18(1):854. doi: 10.1186/s12885-018-4745-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bleomycin	Unknown	15000 iu	Intravenous
Subject	Bleomycin	Unknown	30000 iu	Intravenous
Subject	Cisplatin	Other / unclassified	20 mg/m2	Intravenous
Subject	Etoposide	Small molecule	100 mg/m2	Intravenous
Background	Pegfilgrastim	Protein / enzyme biologic	6 mg	—
Background	filgrastim	Protein / enzyme biologic	10 ug/kg	—

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

Summary

Timeline

Publications

Drugs

Indications