2012年11月
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
JAPANESE JOURNAL OF CLINICAL ONCOLOGY
- 巻
- 42
- 号
- 11
- 開始ページ
- 1094
- 終了ページ
- 1098
- 記述言語
- 英語
- 掲載種別
- 研究論文(学術雑誌)
- DOI
- 10.1093/jjco/hys143
- 出版者・発行元
- OXFORD UNIV PRESS
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 CalmetteGurin 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 CalmetteGurin 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.
- リンク情報
- ID情報
-
- DOI : 10.1093/jjco/hys143
- ISSN : 0368-2811
- PubMed ID : 22952293
- Web of Science ID : WOS:000310373900017