Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fudan University
• Collaborator: Peking Union Medical College Hospital
• Treatments: Letrozole; Medroxyprogesterone; Medroxyprogesterone Acetate; Megestrol; Megestrol Acetate

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)