Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer
Endometrial Neoplasm Malignant Stage I
About this trial
This is an interventional treatment trial for Endometrial Neoplasm Malignant Stage I focused on measuring early endometrial carcinoma, fertility-preserving treatment, gonadotropin-releasing hormone analogue, aromatase inhibitors
Eligibility Criteria
Inclusion Criteria:
- Consent informed and signed
- Primarily have a confirmed diagnosis of early-stage endometrial cancer (endometrioid, grade I, without myometrial inva- sion) ) based upon endometrial biopsy, diagnostic curettage or hysteroscopy
- No signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS)
- Have a strong desire for remaining reproductive function or uterus
- Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time
Exclusion Criteria:
- Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis
- Recurrent endometrial cancer
- Combined with severe medical disease or severely impaired liver and kidney function
- Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; patients with breast cancer or other hormone- dependent tumors that cannot be used with progesterone
- Those who require hysterectomy or other methods other than conservative treatment with drugs
- Known or suspected pregnancy
- Contraindication for Medroxyprogesterone Acetate, Megestrol Acetate, Triprorelin Acetate, Letrozole or pregnancy
- Hormone treatment within 3 months before entering the trial;
- Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
- Smoker(>15 cigarettes a day)
Sites / Locations
- Obstetrics and Gynecology Hospital, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
GnRHa+letrozole
MA/MPA
Patients will be stratified into BMI≥28kg/m2 group and BMI<28kg/m2 group. Patients in BMI≥28kg/m2 or BMI<28kg/m2 group will be randomly assigned (1:1) to GnRHa+letrozole group or MA/MPA group. Patients who will be assigned to GnRHa+letrozole group will receive triprorelin acetate (intramuscular injection of 3.75mg was given 4 weeks apart and the maximum use are 6 courses) plus letrozole (2.5mg oral daily and no more than 24 weeks). Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.
Patients will be stratified into BMI≥28kg/m2 group and BMI<28kg/m2 group. Patients in BMI≥28kg/m2 or BMI<28kg/m2 group were randomly assigned (1:1) to GnRHa+letrozole group or MA/MPA group.Patients assigned to MA/MPA group will receive MA/MPA (160 mg oral MA daily or 500 mg oral MPA daily).Then every 3 months, an hysteroscopy will be used to evaluate the endometrial condition, and the findings will be recorded.