title: 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.
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.
authors.affiliation: Japan Clinical Oncology Group Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo, Japan.
authors.forename: Futoshi
authors.initials: F
authors.lastname: Kunieda
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kitamura
authors.forename: Masashi
authors.initials: M
authors.lastname: Niwakawa
authors.forename: Kentaro
authors.initials: K
authors.lastname: Kuroiwa
authors.forename: Nobuo
authors.initials: N
authors.lastname: Shinohara
authors.forename: Kenichi
authors.initials: K
authors.lastname: Tobisu
authors.forename: Kenichi
authors.initials: K
authors.lastname: Nakamura
authors.forename: Taro
authors.initials: T
authors.lastname: Shibata
authors.forename: Toyonori
authors.initials: T
authors.lastname: Tsuzuki
authors.forename: Taiji
authors.initials: T
authors.lastname: Tsukamoto
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Kakehi
mesh_terms: D000283:Administration, Intravesical; D044466:Asian People; D001500:BCG Vaccine / Q000008:administration & dosage / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D008495:Medical Oncology; D060787:Neoplasm Grading; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D016019:Survival Analysis; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000187:drug effects* / Q000473:pathology / Q000601:surgery; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000208:ethnology / Q000601:surgery; D057832:Watchful Waiting
chemical_list: D001500:BCG Vaccine