A Phase III trial of a single early intravesical instillation of pirarubicin to prevent bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403, UTUC THP Phase III)

Urologic Oncology Study Group of the Japan Clinical Oncology Group

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Observation is the current standard for managing cases of Stage 0a-III upper tract urothelial carcinoma after radical nephroureterectomy. A randomized Phase III trial commenced in Japan during October 2016. The trial is designed to investigate the superiority of a single early intravesical instillation of pirarubicin, compared with observation, in terms of relapse-free survival after radical nephroureterectomy for Stage 0a-III upper tract urothelial carcinoma. During a 5-year period, 310 patients will be recruited from 43 Japanese institutions. The primary endpoint is defined as relapse-free survival, and the secondary endpoints are overall survival, intravesical relapse-free survival, adverse events, and serious adverse events. This trial has been registered in the UMIN.

Original languageEnglish
Pages (from-to)94-97
Number of pages4
JournalJapanese journal of clinical oncology
Volume48
Issue number1
Publication statusPublished - 2018 Jan 1

Keywords

  • Intravesical instillation
  • Phase III
  • Pirarubicin
  • Upper tract urothelial carcinoma

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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