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.
Written by:
Kunieda F, Kitamura H, Niwakawa M, Kuroiwa K, Shinohara N, Tobisu K, Nakamura K, Shibata T, Tsuzuki T, Tsukamoto T, Kakehi Y. Are you the author?
Japan Clinical Oncology Group Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
Reference: Jpn J Clin Oncol. 2012 Sep 5. Epub ahead of print.
doi: 10.1093/jjco/hys143
PubMed Abstract
PMID: 22952293
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