title: Non-randomized confirmatory trial of modified radical hysterectomy for patients with tumor diameter 2 cm or less FIGO Stage IB1 uterine cervical cancer: Japan Clinical Oncology Group Study (JCOG1101).
abstract: A non-randomized confirmatory trial was started in Japan to evaluate the efficacy of modified radical hysterectomy in patients with tumor diameter 2 cm or less FIGO Stage IB1 uterine cervical cancer, for which the current standard is radical hysterectomy. This study began in January 2013 and a total of 240 patients will be accrued from 37 institutions within 3 years. The primary endpoint is 5-year survival. The secondary endpoints are overall survival, relapse-free survival, local relapse-free survival, percent completion of modified radical hysterectomy, percent local relapse, percent pathological parametrial involvement, days until self-urination and residual urine disappearance, blood loss, operation time, percent post-operative radiation therapy, adverse events and severe adverse events. This trial was registered at the UMIN Clinical Trials Registry as UMIN 000009726 (http://www.umin.ac.jp/ctr/).
authors.affiliation: Japan Clinical Oncology Group Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
authors.forename: Futoshi
authors.initials: F
authors.lastname: Kunieda
authors.affiliation: Department of Obstetrics and Gynecology, Tokyo Metropolitan Bokutoh Hospital, Tokyo takahiro_kasamatsu@tmhp.jp.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Kasamatsu
authors.affiliation: Department of Obstetrics and Gynecology, The University of Tokyo, Tokyo.
authors.forename: Takahide
authors.initials: T
authors.lastname: Arimoto
authors.affiliation: Department of Obstetrics and Gynecology, Kitasato University Hospital, Kanagawa.
authors.forename: Takashi
authors.initials: T
authors.lastname: Onda
authors.affiliation: Department of Radiology, University of the Ryukyus Hospital, Okinawa.
authors.forename: Takafumi
authors.initials: T
authors.lastname: Toita
authors.affiliation: Japan Clinical Oncology Group Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
authors.forename: Taro
authors.initials: T
authors.lastname: Shibata
authors.affiliation: Japan Clinical Oncology Group Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.affiliation: Department of Gynecology, Kurume University, Kurume, Japan.
authors.forename: Toshiharu
authors.initials: T
authors.lastname: Kamura
mesh_terms: D000328:Adult; D016063:Blood Loss, Surgical; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007044:Hysterectomy / Q000379:methods*; D007564:Japan; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis; D009367:Neoplasm Staging; D018579:Patient Selection; D016896:Treatment Outcome; D014554:Urination; D002583:Uterine Cervical Neoplasms / Q000473:pathology* / Q000601:surgery*
keywords: FIGO stage IB1 (≤2 cm) uterine cervical cancer; Phase III; clinical trials; modified radical hysterectomy