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- Title
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).
- Authors
Kenichi Miyamoto; Akihiro Ito; Masashi Wakabayashi; Junko Eba; Yoichi Arai; Hiroyuki Nishiyama; Mikio Sugimoto; Ryo Yamashita; Yoshiyuki Kakehi
- 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).
- Publication
Japanese Journal of Clinical Oncology, 2018, Vol 48, Issue 1, p94
- ISSN
0368-2811
- Publication type
Article
- DOI
10.1093/jjco/hyx158