Status:
RECRUITING
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Peking Union Medical College Hospital
Conditions:
Endometrial Neoplasm Malignant Stage I
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
To see if Gonadotropin-releasing hormone analogue (GnRHa) combined with aromatase inhibitors (AIs) will achieve better complete response rate than megestrol acetate or medroxyprogesterone acetate (MA/...
Detailed Description
This will be a multicenter randomized controlled study to evaluate the treatment effects and adverse events of GnRHa plus AIs compared with MA/MPA in primary EEC patients.In this study, young patients...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 10 2027
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT05247268
Start Date
March 11 2022
End Date
September 10 2027
Last Update
April 6 2025
Active Locations (1)
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1
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, China, 200011