A non-randomized confirmatory study to expand the indication of fertility-sparing surgery for patients with epithelial ovarian cancer (JCOG1203, FSS for EOC)
- Conditions
- 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
- Registration Number
- JPRN-UMIN000013380
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 600
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 5-year overall survival
- Secondary Outcome Measures
Name Time Method 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