title: A non-randomized confirmatory study regarding selection of fertility-sparing surgery for patients with epithelial ovarian cancer: Japan Clinical Oncology Group Study (JCOG1203).
abstract: Fertility-sparing treatment has been accepted as a standard treatment for epithelial ovarian cancer in stage IA non-clear cell histology grade 1/grade 2. In order to expand an indication of fertility-sparing treatment, we have started a non-randomized confirmatory trial for stage IA clear cell histology and stage IC unilateral non-clear cell histology grade 1/grade 2. The protocol-defined fertility-sparing surgery is optimal staging laparotomy including unilateral salpingo-oophorectomy, omentectomy, peritoneal cytology and pelvic and para-aortic lymph node dissection or biopsy. After fertility-sparing surgery, four to six cycles of adjuvant chemotherapy with paclitaxel and carboplatin are administered. We plan to enroll 250 patients with an indication of fertility-sparing surgery, and then the primary analysis is to be conducted for 63 operated patients with pathologically confirmed stage IA clear cell histology and stage IC unilateral non-clear cell histology grade 1/grade 2. The primary endpoint is 5-year overall survival. Secondary endpoints are other survival endpoints and factors related to reproduction. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000013380.
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Ibaraki toyomi-s@md.tsukuba.ac.jp.
authors.forename: Toyomi
authors.initials: T
authors.lastname: Satoh
authors.affiliation: Department of Pathology, National Defense Medical College, Saitama.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Tsuda
authors.affiliation: JCOG Data Center, Center for Research Administration and Support, National Cancer Center Hospital, Tokyo.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Kanato
authors.affiliation: JCOG Data Center, Center for Research Administration and Support, National Cancer Center Hospital, Tokyo.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Nakamura
authors.affiliation: JCOG Data Center, Center for Research Administration and Support, National Cancer Center Hospital, Tokyo.
authors.forename: Taro
authors.initials: T
authors.lastname: Shibata
authors.affiliation: Department of Obstetrics and Gynecology, National Defense Medical College, Saitama.
authors.forename: Masashi
authors.initials: M
authors.lastname: Takano
authors.affiliation: Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine, Kyoto.
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Baba
authors.affiliation: Department of Gynecology, National Cancer Center Hospital, Tokyo.
authors.forename: Mitsuya
authors.initials: M
authors.lastname: Ishikawa
authors.affiliation: Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka.
authors.forename: Kimio
authors.initials: K
authors.lastname: Ushijima
authors.affiliation: Department of Obstetrics and Gynecology, Tohoku University Hospital, Miyagi, Japan.
authors.forename: Nobuo
authors.initials: N
authors.lastname: Yaegashi
authors.affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Ibaraki.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yoshikawa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D000077216:Carcinoma, Ovarian Epithelial; D017024:Chemotherapy, Adjuvant; D005260:Female; D005298:Fertility; D006801:Humans; D007247:Infertility, Female / Q000209:etiology / Q000517:prevention & control*; D007564:Japan; D009367:Neoplasm Staging; D009375:Neoplasms, Glandular and Epithelial / Q000473:pathology / Q000601:surgery*; D010051:Ovarian Neoplasms / Q000473:pathology / Q000601:surgery*; D010052:Ovariectomy / Q000379:methods*; D017239:Paclitaxel / Q000008:administration & dosage; D012489:Salpingostomy; D016896:Treatment Outcome
chemical_list: D016190:Carboplatin; D017239:Paclitaxel
keywords: early stage; fertility-sparing surgery; gynecol-surg; gynecology; ovarian cancer