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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Randomized Multicentic Prospective Controlled Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Procedure: endometrial cancer radical surgery
* Procedure: fertility-sparing surgery
* Procedure: ovarian preservation surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radical surgery group<br>Endometrial cancer radical surgery to be administered in this arm. | Procedure: endometrial cancer radical surgery<br>* Take hysterectomy and bilateral adnexectomy.<br>|
| Experimental: fertility preservation group<br>Fertility-sparing surgery to be administered in this arm. | Procedure: fertility-sparing surgery<br>* Take endometrectomy , preserve uterus and bilateral ovaries.<br>|
| Experimental: ovarian preservation group<br>Ovarian preservation surgery to be administered in this arm. | Procedure: ovarian preservation surgery<br>* Take hysterectomy,preserve bilateral ovaries.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total survival Time | calculate the time from patients enter the group to death | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preservation of fertility surger, ovarian preservation, endometrial cancer