Identifying clinical improvement in consolidation single-arm phase 2 trials in patients with ovarian cancer in second or greater clinical remission Academic Article uri icon

Overview

MeSH Major

  • Antineoplastic Agents
  • Clinical Trials, Phase II as Topic
  • Ovarian Neoplasms
  • Research Design

abstract

  • Designs of nonrandomized consolidation trials that aim to prolong PFS must consider the effect of the duration of SLT on the end point definition and on required sample size. If IT is given concurrently with SLT, and after SLT, then SLT duration must be restricted per protocol eligibility, so that a comparison with historical data from other single-arm phase 2 studies is unbiased. If IT is given after SLT, the duration of SLT should be taken into account in the design stage because it will affect statistical power and sample size.

publication date

  • January 2012

Research

keywords

  • Academic Article

Identity

Language

  • eng

PubMed Central ID

  • PMC3296556

Digital Object Identifier (DOI)

  • 10.1097/IGC.0b013e31822e29aa

PubMed ID

  • 22080877

Additional Document Info

start page

  • 63

end page

  • 9

volume

  • 22

number

  • 1