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)

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).

Japanese journal of clinical oncology. 2017 Nov 09 [Epub ahead of print]

Kenichi Miyamoto, Akihiro Ito, Masashi Wakabayashi, Junko Eba, Yoichi Arai, Hiroyuki Nishiyama, Mikio Sugimoto, Ryo Yamashita, Yoshiyuki Kakehi, Urologic Oncology Study Group of the Japan Clinical Oncology Group

Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center, Tokyo., Department of Urology, Tohoku University Graduate School of Medicine, Miyagi., Department of Urology, Tsukuba University Hospital, Tochigi., Department of Urology, Kagawa University Faculty of Medicine, Kagawa., Division of Urology, Shizuoka Cancer Center, Shizuoka, Japan.