The Multicentic Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer

Not Applicable

• Conditions: Endometrial Cancer
• Interventions: Procedure: ovarian preservation surgery; Procedure: endometrial cancer radical surgery; Procedure: fertility-sparing surgery

• Registration Number: NCT03804463
• Lead Sponsor: Min Wang

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 Timeline

• Study First Submitted: 2018-06-04
• Status Verified: 2019-01
• Study Start: 2019-01-10
• Study First Submitted QC: 2019-01-14
• Last Update Submitted: 2019-01-14
• Study First Posted: 2019-01-15
• Last Update Posted: 2019-01-15
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ovarian preservation group	ovarian preservation surgery	Ovarian preservation surgery to be administered in this arm.
radical surgery group	endometrial cancer radical surgery	Endometrial cancer radical surgery to be administered in this arm.
fertility preservation group	fertility-sparing surgery	Fertility-sparing surgery to be administered in this arm.

Primary Outcome Measures

Name	Time	Method
Total survival Time	6 months	calculate the time from patients enter the group to death

Secondary Outcome Measures

Name	Time	Method
the change of Ovarian volume	6 months, 1 year, 2 years, 3 years, 4 years, 5 years	measure the ovarian volume dynamically by ultrasonography
the change of endocrine function evaluation	6 months, 1 year, 2 years, 3 years, 4 years, 5 years	measure the endocrine function(hormone level) dynamically by blood detection
Progression Free Survival	6 months	calculate the time from patients enter the group to tumor progression

Trial Locations

Locations (1)

Shengjing Hospitaol of China Medical University; 🇨🇳 Shenyang, Liaoning, China