1. A non-randomized confirmatory study regarding selection of fertility-sparing surgery for patients with epithelial ovarian cancer: Japan Clinical Oncology Group Study (JCOG1203).
- Author
-
Satoh T, Tsuda H, Kanato K, Nakamura K, Shibata T, Takano M, Baba T, Ishikawa M, Ushijima K, Yaegashi N, and Yoshikawa H
- Subjects
- Adult, Aged, Carboplatin administration & dosage, Carcinoma, Ovarian Epithelial, Chemotherapy, Adjuvant, Female, Fertility, Humans, Infertility, Female etiology, Japan, Neoplasm Staging, Neoplasms, Glandular and Epithelial pathology, Ovarian Neoplasms pathology, Paclitaxel administration & dosage, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Infertility, Female prevention & control, Neoplasms, Glandular and Epithelial surgery, Ovarian Neoplasms surgery, Ovariectomy methods, Salpingostomy
- 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., (© The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
- Published
- 2015
- Full Text
- View/download PDF