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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03804463
• Other study ID #: 2017PS017K
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2019
• Source: Shengjing Hospital
• Contact: Min Wang, PHD.
• Phone: 18940251222
• Email: wm21st[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Procedure:
• endometrial cancer radical surgery
Take hysterectomy and bilateral adnexectomy.
• fertility-sparing surgery
Take endometrectomy , preserve uterus and bilateral ovaries.
• ovarian preservation surgery
Take hysterectomy,preserve bilateral ovaries.

Locations

Country	Name	City	State
China	Shengjing Hospitaol of China Medical University	Shenyang	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
Min Wang	First Hospital of China Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total survival Time	calculate the time from patients enter the group to death	6 months
Secondary	the change of Ovarian volume	measure the ovarian volume dynamically by ultrasonography	6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	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
Secondary	Progression Free Survival	calculate the time from patients enter the group to tumor progression	6 months