Satoh Toyomi, Tsuda Hitoshi, Kanato Keisuke, Nakamura Kenichi, Shibata Taro, Takano Masashi, Baba Tsukasa, Ishikawa Mitsuya, Ushijima Kimio, Yaegashi Nobuo, Yoshikawa Hiroyuki
Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Ibaraki
Department of Pathology, National Defense Medical College, Saitama.
Jpn J Clin Oncol. 2015 Jun;45(6):595-9. doi: 10.1093/jjco/hyv032. Epub 2015 Mar 25.
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.
保留生育功能的治疗已被接受为IA期非透明细胞组织学1/2级上皮性卵巢癌的标准治疗方法。为了扩大保留生育功能治疗的适应症，我们已开始针对IA期透明细胞组织学和IC期单侧非透明细胞组织学1/2级开展一项非随机验证性试验。方案定义的保留生育功能手术是最佳分期剖腹手术，包括单侧输卵管卵巢切除术、大网膜切除术、腹腔细胞学检查以及盆腔和腹主动脉旁淋巴结清扫或活检。保留生育功能手术后，给予四至六个周期的紫杉醇和卡铂辅助化疗。我们计划招募250例有保留生育功能手术适应症的患者，然后对63例经病理证实为IA期透明细胞组织学和IC期单侧非透明细胞组织学1/2级的手术患者进行初步分析。主要终点是5年总生存率。次要终点是其他生存终点以及与生殖相关的因素。该试验已在UMIN临床试验注册中心注册，注册号为UMIN000013380。
