The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma

Not Applicable

Active, not recruiting

• Conditions: Endometrial Neoplasms
• Interventions: Procedure: TH/BSO; Procedure: TH; Procedure: BPLND

• 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

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2025-12
• Study Completion: 2026-12

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

Arm && Interventions

Group	Intervention	Description
TH and bilateral salpingo-oophorectomy (TH/BSO)	TH/BSO	Patients may receive total hysterectomy, bilateral salpingo-oophorectomy (BSO) and bilateral pelvic and para-aortic lymph node dissection.
TH and bilateral salpingo-oophorectomy (TH/BSO)	BPLND	Patients may receive total hysterectomy, bilateral salpingo-oophorectomy (BSO) and bilateral pelvic and para-aortic lymph node dissection.
Total Hysterectomy (TH)	TH	Patients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND).
Total Hysterectomy (TH)	BPLND	Patients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND).

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