RecruitingPhase 2NCT05247268

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

Gonadotropin-releasing Hormone Agonist Combined With Letrozole Compared With Megestrol Acetate or Medroxyprogesterone Acetate Alone as Fertility-sparing Treatment in Early Endometrial Cancer


Sponsor

Fudan University

Enrollment

104 participants

Start Date

Mar 11, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a hormone-based treatment combination for young women with very early-stage uterine (endometrial) cancer who want to preserve their ability to have children. Instead of surgery to remove the uterus, participants receive a combination of hormonal medications to see if the cancer can be controlled without losing fertility. **You may be eligible if...** - You have early-stage endometrial cancer (grade 1, endometrioid type, no spread into the uterine wall) confirmed by biopsy - Imaging scans show no signs of the cancer spreading beyond the uterus - You strongly wish to preserve your fertility or uterus - You are able to attend regular follow-up appointments at the study hospital **You may NOT be eligible if...** - Your cancer has grown into the uterine wall or spread outside the uterus - Your cancer has returned after prior treatment - You have serious liver or kidney disease - You have another type of uterine or reproductive cancer, breast cancer, or a hormone-sensitive tumor - Your doctor recommends hysterectomy or a non-hormonal treatment approach Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMegestrol Acetate 160 MG Oral Tablet

At a dosage of 160 mg/day

DRUGMedroxyprogesterone Acetate 500 MG

At a dosage of 500 mg/day

DRUGTriprorelin Acetate

Intramuscular injection of 3.75mg was given 4 weeks apart and the maximum use are 6 courses

DRUGLetrozole 2.5mg

At a dosage of 2.5mg/day and no more than 24 weeks


Locations(1)

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, China

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NCT05247268


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