Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer
Recruiting now · Phase 2
Conditions studied: Endometrial Neoplasm Malignant Stage I
In brief
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/MPA) alone as fertility-sparing treatment for patients with early endometrial carcinoma.
Key facts
- Study ID
- NCT05247268
- Run by
- Fudan University
- People needed
- 104
- Starts
- 2022-03-11
- Expected to finish
- 2027-09-10
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Obstetrics and Gynecology Hospital, Fudan University — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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