Watchful Waiting Versus Intravesical BCG Therapy for High-grade pT1 Bladder Cancer with pT0 Histology After Second Transurethral Resection: Japan Clinical Oncology Group Study JCOG1019
Kunieda F, Kitamura H, Niwakawa M, Kuroiwa K, Shinohara N, Tobisu K, Nakamura K, Shibata T, Tsuzuki T, Tsukamoto T, Kakehi Y; Urologic Oncology Study Group of the Japan Clinical Oncology Group. Jpn J Clin Oncol. 2012 Sep 5. [Epub ahead of print]

Source 1Japan Clinical Oncology Group Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.

Abstract

A Phase III clinical trial has been started in Japan to determine the optimal treatment strategy for patients with high-grade pT1 bladder cancer who have pT0 histology after second transurethral resection. The aim of this trial is to demonstrate the non-inferiority of relapse-free survival (excluding Tis or Ta intravesical recurrence) for watchful waiting compared with intravesical bacillus Calmette-Guérin therapy for pT0 after second transurethral resection. Patients with high-grade pT1 bladder cancer at the first registration and pT0 after second transurethral resection at the second registration are randomized to either a watchful waiting arm or an intravesical bacillus Calmette-Guérin therapy arm. A total of 575 patients at the first registration and 260 patients at the second registration will be accrued for this study from 38 institutions over 5 years. The primary endpoint is relapse-free survival (excluding Tis or Ta intravesical recurrence), and the secondary endpoints are overall survival, metastasis-free survival with bladder preserved, annual proportion of intravesical relapse-free survival, annual proportion of T2 or deeper relapse-free survival, adverse events and serious adverse events.