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

Min Wang

Status: Unknown

Conditions: Endometrial Cancer

Treatments: Procedure: endometrial cancer radical surgery; Procedure: ovarian preservation surgery; Procedure: fertility-sparing surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03804463

2017PS017K

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 estimated patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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170 participants in 3 patient groups

radical surgery group

Experimental group

Description:

Endometrial cancer radical surgery to be administered in this arm.

Treatment:

Procedure: endometrial cancer radical surgery

fertility preservation group

Experimental group

Description:

Fertility-sparing surgery to be administered in this arm.

Treatment:

Procedure: fertility-sparing surgery

ovarian preservation group

Experimental group

Description:

Ovarian preservation surgery to be administered in this arm.

Treatment:

Procedure: ovarian preservation surgery