AGCT1532: 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

Grants and Contracts Details

Description

AGCT1532 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 General aim To determine if accelerated BEP (Bleomycin, Etoposide, cisPlatin) is superior to standard BEP as first-line chemotherapy for intermediate and poor-risk metastatic GCTs. 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: 1) Response following treatment completion (protocol-specific response criteria) 2) Adverse events (worst grade according to NCI CTCAE v4.03) 3) Health-related quality of life (Summary scales from QLQ-C30 & -TC-26) 4) Treatment preference (Proportion preferring each treatment arm) 5) Delivered dose-intensity of chemotherapy (Relative to standard BEP) 6) Overall survival (death from any cause) Correlative objectives In the future, funding permitting, we will determine associations between biomarkers to be specified and their correlations with clinical outcomes.
StatusActive
Effective start/end date5/1/2111/10/22

Funding

  • Public Health Institute: $2.00

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