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)

Jpn J Clin Oncol. 2018 Jan 1;48(1):94-97. doi: 10.1093/jjco/hyx158.

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 Clinical Trials Registry (UMIN000024267, http://www.umin.ac.jp/ctr/index.htm).

Keywords: Phase III; intravesical instillation; pirarubicin; upper tract urothelial carcinoma.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Administration, Intravesical
  • Doxorubicin / administration & dosage
  • Doxorubicin / analogs & derivatives*
  • Doxorubicin / therapeutic use
  • Follow-Up Studies
  • Humans
  • Japan
  • Neoplasm Recurrence, Local / drug therapy*
  • Neoplasm Recurrence, Local / prevention & control*
  • Nephrectomy
  • Nephroureterectomy*
  • Urinary Bladder Neoplasms / drug therapy*
  • Urinary Bladder Neoplasms / pathology
  • Urinary Bladder Neoplasms / surgery*

Substances

  • Doxorubicin
  • pirarubicin