Back to resultsThe Multicentic Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer
Primary Purpose
Endometrial Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
endometrial cancer radical surgery
fertility-sparing surgery
ovarian preservation surgery
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer focused on measuring Preservation of fertility surger, ovarian preservation, endometrial cancer
Eligibility Criteria
Inclusion Criteria:
- Premenopausal women, age ≤ 50 years
- Surgical curettage / hysteroscopic pathology confirmed, endometrioid adenocarcinoma G1/G2 (including well-differentiated, high-medium and middle-differentiation);
- Clinical consideration of IA (<1/2 muscle infiltration);
- First-time treatment
- The subject (or his legal representative) must understand the nature of the study and sign an informed consent form.
Exclusion Criteria:
- At the same time participate in other clinical trials;
- Can not tolerate surgery;
- Ovarian suspicious metastasis;
- Have a family history of ovarian cancer;
- Incorporate other malignant tumors;
- Preoperative CA125 abnormal persons
Sites / Locations
- Shengjing Hospitaol of China Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
radical surgery group
fertility preservation group
ovarian preservation group
Arm Description
Endometrial cancer radical surgery to be administered in this arm.
Fertility-sparing surgery to be administered in this arm.
Ovarian preservation surgery to be administered in this arm.
Outcomes
Primary Outcome Measures
Total survival Time
calculate the time from patients enter the group to death
Secondary Outcome Measures
the change of Ovarian volume
measure the ovarian volume dynamically by ultrasonography
the change of endocrine function evaluation
measure the endocrine function(hormone level) dynamically by blood detection
Progression Free Survival
calculate the time from patients enter the group to tumor progression
Full Information
NCT ID
NCT03804463
First Posted
June 4, 2018
Last Updated
January 14, 2019
Sponsor
Min Wang
Collaborators
First Hospital of China Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03804463
Brief Title
The Multicentic Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer
Official Title
The Randomized Multicentic Prospective Controlled Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2019 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Min Wang
Collaborators
First Hospital of China Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Through multicenter, prospective, randomized, controlled clinical studies comparing different treatment options (fertility-sparing surgery and ovarian preservation surgery and radical surgery)therapeutic efficacy, safety and quality of life of patients, exploration of the best strategies and risks for the treatment of early endometrial cancer, and promotion and application.
Detailed Description
Patients eligible for enrollment are selected and divided into three groups randomly, including fertility group,ovarian preservation group and endometrial cancer radical surgery group. Take interventions including fertility preservation surgery,ovarian preservation surgery and endometrial cancer radical surgery for patients in different groups respectively. Compare therapeutic efficacy, safety and quality of life of patients to evaluate three treatment and explore the best treatment for clinical application.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
Preservation of fertility surger, ovarian preservation, endometrial cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
radical surgery group
Arm Type
Experimental
Arm Description
Endometrial cancer radical surgery to be administered in this arm.
Arm Title
fertility preservation group
Arm Type
Experimental
Arm Description
Fertility-sparing surgery to be administered in this arm.
Arm Title
ovarian preservation group
Arm Type
Experimental
Arm Description
Ovarian preservation surgery to be administered in this arm.
Intervention Type
Procedure
Intervention Name(s)
endometrial cancer radical surgery
Intervention Description
Take hysterectomy and bilateral adnexectomy.
Intervention Type
Procedure
Intervention Name(s)
fertility-sparing surgery
Intervention Description
Take endometrectomy , preserve uterus and bilateral ovaries.
Intervention Type
Procedure
Intervention Name(s)
ovarian preservation surgery
Intervention Description
Take hysterectomy,preserve bilateral ovaries.
Primary Outcome Measure Information:
Title
Total survival Time
Description
calculate the time from patients enter the group to death
Time Frame
6 months
Secondary Outcome Measure Information:
Title
the change of Ovarian volume
Description
measure the ovarian volume dynamically by ultrasonography
Time Frame
6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Title
the change of endocrine function evaluation
Description
measure the endocrine function(hormone level) dynamically by blood detection
Time Frame
6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Title
Progression Free Survival
Description
calculate the time from patients enter the group to tumor progression
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premenopausal women, age ≤ 50 years
Surgical curettage / hysteroscopic pathology confirmed, endometrioid adenocarcinoma G1/G2 (including well-differentiated, high-medium and middle-differentiation);
Clinical consideration of IA (<1/2 muscle infiltration);
First-time treatment
The subject (or his legal representative) must understand the nature of the study and sign an informed consent form.
Exclusion Criteria:
At the same time participate in other clinical trials;
Can not tolerate surgery;
Ovarian suspicious metastasis;
Have a family history of ovarian cancer;
Incorporate other malignant tumors;
Preoperative CA125 abnormal persons
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Wang, PHD.
Phone
18940251222
Email
wm21st@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
YiSi Liu
Phone
18640138683
Email
liuyisi91@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Wang, PHD.
Organizational Affiliation
Shengjing Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shengjing Hospitaol of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Wang, PHD
Phone
18940251222
Email
wm21st@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Multicentic Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer
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