The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma
EC-02
1 other identifier
interventional
240
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 21, 2013
CompletedFirst Posted
Study publicly available on registry
March 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedApril 2, 2024
April 1, 2024
13.1 years
March 21, 2013
April 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free survival (DFS)
3-year DFS
Secondary Outcomes (3)
Clinical gynecologic endocrine function
1-year period
Quality of Life
3-year period
Overall Survival (OS)
3-year OS
Study Arms (2)
Total Hysterectomy (TH)
EXPERIMENTALPatients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND).
TH and bilateral salpingo-oophorectomy (TH/BSO)
ACTIVE COMPARATORPatients may receive total hysterectomy, bilateral salpingo-oophorectomy (BSO) and bilateral pelvic and para-aortic lymph node dissection.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ding Malead
- Shandong Universitycollaborator
- Huazhong University of Science and Technologycollaborator
- Zhejiang Universitycollaborator
Study Sites (3)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Qilu Hospital，Shandong University
Jinan, Shandong, 250012, China
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Beihua Kong, MD, PhD
Shandong University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of the department of Obstetrics and Gynecology, Tongji Hospital
Study Record Dates
First Submitted
March 21, 2013
First Posted
March 29, 2013
Study Start
November 1, 2012
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
April 2, 2024
Record last verified: 2024-04