Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours (P3BEP)
Categories (click each to see list of all clinical trials associated with that category): Pediatric (PEDONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Beck, Jill
Eligibility: https://clinicaltrials.gov/study/NCT02582697?term=NCT02582697&rank=1#participation-criteria
Summary
Primary objectives (endpoints)
To compare the two treatment arms with respect to:
1) Progression-free survival (disease progression or death)
Secondary objectives (endpoints)
To compare the two treatment arms with respect to:
2) Response following treatment completion (protocol-specific response criteria)
3) Adverse events (worst grade according to NCI CTCAE v4.03)
4) Health-related quality of life (Summary scales from QLQ-C30 & -TC-26)
5) Treatment preference (Proportion preferring each treatment arm)
6) Delivered dose-intensity of chemotherapy (Relative to standard BEP)
7) Overall survival (death from any cause)