Endometrial Cancer
Conditions
Keywords
Preservation of fertility surger, ovarian preservation, 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.
Interventions
PROCEDUREendometrial cancer radical surgery
Take hysterectomy and bilateral adnexectomy.
PROCEDUREfertility-sparing surgery
Take endometrectomy , preserve uterus and bilateral ovaries.
PROCEDUREovarian preservation surgery
Take hysterectomy,preserve bilateral ovaries.
Sponsors
First Hospital of China Medical University
Min Wang
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total survival Time | 6 months | calculate the time from patients enter the group to death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactMin Wang, PHD.
Backup ContactYiSi Liu
Outcome results
None listed