Back to resultsThe Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma (EC-02)
Primary Purpose
Endometrial Neoplasms
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TH
TH/BSO
BPLND
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Neoplasms
Eligibility Criteria
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.
Sites / Locations
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Qilu Hospital，Shandong University
- Women's Hospital, School of Medicine, Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Total Hysterectomy (TH)
TH and bilateral salpingo-oophorectomy (TH/BSO)
Arm Description
Patients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND).
Patients may receive total hysterectomy, bilateral salpingo-oophorectomy (BSO) and bilateral pelvic and para-aortic lymph node dissection.
Outcomes
Primary Outcome Measures
Disease-free survival (DFS)
Secondary Outcome Measures
Clinical gynecologic endocrine function
To observe the level of female hormone，i.e., estrogen, FSH, LH
Quality of Life
Overall Survival (OS)
Full Information
NCT ID
NCT01820884
First Posted
March 21, 2013
Last Updated
May 7, 2023
Sponsor
Ding Ma
Collaborators
Shandong University, Huazhong University of Science and Technology, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT01820884
Brief Title
The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma
Acronym
EC-02
Official Title
The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma: A Multicenter, Prospective, Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ding Ma
Collaborators
Shandong University, Huazhong University of Science and Technology, Zhejiang University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total Hysterectomy (TH)
Arm Type
Experimental
Arm Description
Patients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND).
Arm Title
TH and bilateral salpingo-oophorectomy (TH/BSO)
Arm Type
Active Comparator
Arm Description
Patients may receive total hysterectomy, bilateral salpingo-oophorectomy (BSO) and bilateral pelvic and para-aortic lymph node dissection.
Intervention Type
Procedure
Intervention Name(s)
TH
Intervention Description
Total hysterectomy
Intervention Type
Procedure
Intervention Name(s)
TH/BSO
Intervention Description
Total hysterectomy and bilateral salpingo-oophorectomy
Intervention Type
Procedure
Intervention Name(s)
BPLND
Intervention Description
bilateral pelvic and para-aortic lymph node dissection
Primary Outcome Measure Information:
Title
Disease-free survival (DFS)
Time Frame
3-year DFS
Secondary Outcome Measure Information:
Title
Clinical gynecologic endocrine function
Description
To observe the level of female hormone，i.e., estrogen, FSH, LH
Time Frame
1-year period
Title
Quality of Life
Time Frame
3-year period
Title
Overall Survival (OS)
Time Frame
3-year OS
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beihua Kong, MD, PhD
Organizational Affiliation
Shandong University
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Qilu Hospital，Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Women's Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma
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