AGCT1532, Randomized Phase 3 Trial of Accelerated vs Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastic Germ Cell Tumors
Objective
Primary objectives To compare the two treatment arms with respect to: Progression-free survival (disease progression or death
Secondary objectives To compare the two treatment arms with respect to: Response following treatment completion (protocol-specific response criteria) Adverse events (worst grade according to NCI CTCAE v4.03) Health-related quality of life (Summary scales from QLQ-C30 & -TC-26) Treatment preference (Proportion preferring each treatment arm) Delivered dose-intensity of chemotherapy (Relative to standard BEP) Overall survival (death from any cause)
