AI Article Synopsis
- Observation is the standard treatment for Stage 0a-III upper tract urothelial carcinoma after surgery called radical nephroureterectomy.
- A randomized Phase III trial started in Japan in October 2016 to compare the effectiveness of a single dose intravesical treatment with pirarubicin against observation for improving relapse-free survival.
- The trial aims to enroll 310 patients over 5 years from 43 institutions, measuring primary outcomes like relapse-free survival and secondary outcomes such as overall survival and adverse effects.
Article 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).
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| http://dx.doi.org/10.1093/jjco/hyx158 | DOI Listing |
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