Presumed ovarian clear cell carcinoma stage IA or other type of epithelial ovarian carcinoma stage IC (unilateral) grade 1/2 before complete fertility-sparing surgery
Conditions
Interventions
A: Fertility-sparing surgery with staging surgery. Adjuvant chemotherapy is performed on patients who were diagnosed as having ovarian clear cell carcinoma stage IA or other type of epithelial ovarian
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) To fulfill I or II I. When tumor is detected in pelvic enhanced MRI and CT within 84 days before registration and it is presumed stage I epithelial ovarian cancer (neither surgery nor biopsy for ovarian tumor before registration), both of the followings are fulfilled: 1) Existence of ovarian tumor with solid part which is suspected as epithelial ovarian cancer 2) No Lymph node or distant metastasis by imaging examination II. When incomplete staging surgery is performed on a patient with ovarian tumor by laparotomy or laparoscopic surgery within 84 days before registration and the tumor is diagnosed as epithelial ovarian cancer histologically, the following (1) to (4) are fulfilled: 1) Diagnosed as either i), ii) or iii) by some specimens of resected ovarian tumor or biopsy at surgery within 84 days before registration i) Clear cell histology (CCH) ii) Non-clear cell histology epithelial cancer [serous, mucinous, endometrioid] (non-CCH) Grade 1 iii) Non-clear cell histology epithelial cancer [serous, endometrioid] (non-CCH) Grade 2 2) Possibility of one of the following stage (FIGO 2014) after fertility-sparing surgery (FSS) i) Clear cell histology: stage IA ii) Non-clear cell histology: stage IC (unilateral) 3) Needing to receive re-staging surgery 4) The uterus and the ovary being left (2) The patient wishes to receive FSS by informed consent. (3) Keeping an ability of childbirth (4) ECOG performance status (PS) of 0 or 1 (5) Measurable disease or non-measurable (6) No prior treatment with irradiation or chemotherapy for any malignancy. (7) Adequate organ functions (8) No abnormal finding to need treatment on 12-lead ECG (9) Written informed consent by the patient of 20 years or older. Written informed consent by both of the patient and the parent, if the patient is under 20 years old
Exclusion criteria
Exclusion criteria: (1)Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or intramucosal tumors curatively treated with local therapy (2) Active systemic infections to be treated. (3) Body temperature of 38 or more degrees Celsius (4) Women during pregnancy, possible pregnancy, or breast-feeding (5) Psychiatric disease (6) Continuous systemic steroid treatment (7) Uncontrolled diabetes mellitus or routine administration of insulin (8) Uncontrolled hypertension (9) Unstable angina or prior myocardial infarction with in 6 months (10) HBs antigen positive, HCV antibody positive, HIV antibody positive (11) Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema (12) hypersensitivity to polyoxyethylated castor oil (13) hypersensitivity to alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, recurrence-free survival, lethal recurrence-free survival, recovered menstruation proportion, recovered menstruation cycle proportion, pregnancy proportion, live birth proportion, intra and postoperative complication, adverse events, severe adverse events | — |
Countries
Japan
Contacts
Public ContactToyomi Satoh
JCOG1203 Coordinating Office Obstetrics & Gynecology, Faculty of Medicine, University of Tsukuba
Outcome results
None listed