論文

査読有り
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
  • Futoshi Kunieda
  • ,
  • Hiroshi Kitamura
  • ,
  • Masashi Niwakawa
  • ,
  • Kentaro Kuroiwa
  • ,
  • Nobuo Shinohara
  • ,
  • Kenichi Tobisu
  • ,
  • Kenichi Nakamura
  • ,
  • Taro Shibata
  • ,
  • Toyonori Tsuzuki
  • ,
  • Taiji Tsukamoto
  • ,
  • Yoshiyuki Kakehi

42
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.

Web of Science ® 被引用回数 : 7

リンク情報
DOI
https://doi.org/10.1093/jjco/hys143
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/22952293
Web of Science
https://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=JSTA_CEL&SrcApp=J_Gate_JST&DestLinkType=FullRecord&KeyUT=WOS:000310373900017&DestApp=WOS_CPL

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