JCOG1203: A non-randomized confirmatory study to expand the indication of fertility-sparing surgery for patients with epithelial ovarian cancer
- Conditions
- Clear cell carcinoma stage IA or unilateral epithelial carcinoma stage IC grade 1/2 of the ovary.
- Registration Number
- JPRN-jRCTs031180178
- Lead Sponsor
- SATOH Toyomi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 600
(1) To fulfill I or II
I. When tumor is detected in pelvic enhanced MRI and CT within 12 weeks (84 days) before registration and it is presumed 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 by some specimens of resected ovarian tumor or biopsy at surgery within 84 days before registration, the following (1) to (4) are fulfilled:
1) Diagnosed as either i), ii) or iii)
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 stages (FIGO 2014)
i) Clear cell histology: stage IA
ii) Non-clear cell histology: stage IC (unilateral)
3) Needing to receive re-staging laparotomy
4) The uterus and the other ovary being left
(2) The patient wishes to receive FSS by informed consent.
(3) Keeping an ability of childbirth after FSS
(4) ECOG performance status (PS) of 0 or 1
(5) Measurable disease or non-measurable disease
(6) No prior treatment with irradiation or chemotherapy for any malignancy.
(7) Adequate organ functions with the latest examination within 14 days before registration
(8) No abnormal finding to need treatment on 12-lead ECG within 28 days before registration
(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
(1) Synchronous or metachronous (within 5 years) double malignancies
(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 difficult to participate in this clinical study
(6) Continuous systemic steroid treatment
(7) Uncontrolled diabetes mellitus or routine administration of insulin
(8) Uncontrolled hypertension
(9) Unstable angina (onset or worse heart attack of angina within 3 weeks) 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, Serious adverse events