NCT05247268 Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer
| NCT ID | NCT05247268 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Endometrial Neoplasm Malignant Stage I |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2022-03-11 |
| Primary Completion | 2027-03-10 |
Trial Parameters
Eligibility Fast-Check
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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/MPA) alone as fertility-sparing treatment for patients with early endometrial carcinoma.
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 reprodu