Progression-free and overall survival in patients with relapsed/refractory germ cell tumors treated with single-agent chemotherapy: Endpoints for clinical trial design Academic Article uri icon

Overview

MeSH Major

  • Antineoplastic Agents
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Drug Resistance, Neoplasm
  • Endpoint Determination
  • Neoplasms, Germ Cell and Embryonal

abstract

  • Patients with refractory GCT progressed rapidly to these single agents. PFS and OS may be useful endpoints for designing phase 2 trials testing novel agents in this population. Twelve-week PFS (with comparison to the 9% benchmark rate reported herein) is the recommended endpoint for phase 2 trial design and median OS (using 4.7 months as the predicted median for the control arm) is suggested for phase 3 trials.

publication date

  • February 15, 2012

Research

keywords

  • Academic Article

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.1002/cncr.26375

PubMed ID

  • 21792865

Additional Document Info

start page

  • 981

end page

  • 6

volume

  • 118

number

  • 4