The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma
Not Applicable
Active, not recruiting
- Conditions
- Endometrial Neoplasms
- Registration Number
- NCT01820884
- Lead Sponsor
- Ding Ma
- Brief Summary
This randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA endometrial carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 240
Inclusion Criteria
- FIGO stage: ⅠA, endometrial carcinoma;
- Female, Chinese women;
- premenopausal women；
- ≤ 50 years old;
- Pathological diagnosis by curettage/hysteroscopy : G1
- No prior treatment;
- Provide written informed consent.
Exclusion Criteria
- The suspicious metastasis of ovarian;
- Family history of ovarian cancer;
- Suffering from other malignancies;
- Concurrently participating in other clinical trials;
- Unable or unwilling to sign informed consents;
- Unable or unwilling to abide by protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS) 3-year DFS
- Secondary Outcome Measures
Name Time Method Clinical gynecologic endocrine function 1-year period To observe the level of female hormone，i.e., estrogen, FSH, LH
Quality of Life 3-year period Overall Survival (OS) 3-year OS
Trial Locations
- Locations (3)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Qilu Hospital，Shandong University
🇨🇳Jinan, Shandong, China
Women's Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology🇨🇳Wuhan, Hubei, China