The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma
Overview
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.
Full Title of Study: “The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma: A Multicenter, Prospective, Randomized Trial”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2023
Interventions
- Procedure: TH
- Total hysterectomy
- Procedure: TH/BSO
- Total hysterectomy and bilateral salpingo-oophorectomy
- Procedure: BPLND
- bilateral pelvic and para-aortic lymph node dissection
Arms, Groups and Cohorts
- Experimental: Total Hysterectomy (TH)
- Patients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND).
- Active Comparator: TH and bilateral salpingo-oophorectomy (TH/BSO)
- Patients may receive total hysterectomy, bilateral salpingo-oophorectomy (BSO) and bilateral pelvic and para-aortic lymph node dissection.
Clinical Trial Outcome Measures
Primary Measures
- Disease-free survival (DFS)
- Time Frame: 3-year DFS
Secondary Measures
- Clinical gynecologic endocrine function
- Time Frame: 1-year period
- To observe the level of female hormone,i.e., estrogen, FSH, LH
- Quality of Life
- Time Frame: 3-year period
- Overall Survival (OS)
- Time Frame: 3-year OS
Participating in This Clinical Trial
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.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Ding Ma
- Collaborator
- Shandong University
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Ding Ma, Director of the department of Obstetrics and Gynecology, Tongji Hospital – Huazhong University of Science and Technology
- Overall Official(s)
- Beihua Kong, MD, PhD, Study Chair, Shandong University
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