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
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.
Study Type
Interventional
Primary Outcome
Total survival Time
Secondary Outcome
the change of Ovarian volume
Condition
Endometrial Cancer
Intervention
endometrial cancer radical surgery
Study Arms / Comparison Groups
radical surgery group
Description: Endometrial cancer radical surgery to be administered in this arm.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
170
Start Date
January 10, 2019
Completion Date
December 31, 2021
Primary Completion Date
December 31, 2020
Eligibility Criteria
Inclusion Criteria:
1. Premenopausal women, age ≤ 50 years
2. Surgical curettage / hysteroscopic pathology confirmed, endometrioid adenocarcinoma
G1/G2 (including well-differentiated, high-medium and middle-differentiation);
3. Clinical consideration of IA (<1/2 muscle infiltration);
4. First-time treatment
5. The subject (or his legal representative) must understand the nature of the study and
sign an informed consent form.
Exclusion Criteria:
1. At the same time participate in other clinical trials;
2. Can not tolerate surgery;
3. Ovarian suspicious metastasis;
4. Have a family history of ovarian cancer;
5. Incorporate other malignant tumors;
6. Preoperative CA125 abnormal persons
Gender
Female
Ages
21 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Min Wang, PHD., 18940251222, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03804463
Organization ID
2017PS017K
Responsible Party
Sponsor-Investigator
Study Sponsor
Min Wang
Collaborators
First Hospital of China Medical University
Study Sponsor
Min Wang, PHD., Study Director, Shengjing Hospital
Verification Date
January 2019