RecruitingPhase 2Phase 3NCT05316935

GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Non-obese Progestin-insensitive Early-stage Endometrial Cancer and Atypical Hyperplasia Patients With Conservative Treatment


Sponsor

Xiaojun Chen

Enrollment

80 participants

Start Date

Jul 13, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a combination of GnRHa (a hormone injection that suppresses ovarian function) plus letrozole (a hormone blocker) can treat early-stage uterine cancer or atypical uterine thickening (endometrial atypical hyperplasia) in non-obese women who did not respond to progestin therapy. This fertility-sparing approach is for women who want to avoid a hysterectomy. **You may be eligible if...** - Your biopsy confirmed grade 1 endometrial cancer (EEC G1) or endometrial atypical hyperplasia (EAH), with no spread into the uterine muscle - Your BMI is under 30 kg/m² (not obese) - Imaging (MRI/CT/ultrasound) shows no signs of cancer outside the uterus - You previously tried progestin therapy (megestrol acetate or medroxyprogesterone) and it did not achieve a complete response **You may NOT be eligible if...** - Your cancer has grown into the uterine wall or spread beyond the uterus - You are obese (BMI ≥ 30) - You have not tried progestin-based therapy first 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

DRUGGnRHa

Gonadotropin-releasing hormone analogue, intramuscular injection of 3.75mg will be given every 4 weeks , and the maximum using courses will be 6.

DRUGLetrozole 2.5mg

2.5mg po qd and no more than 24 weeks

DRUGDiane-35

Periodic use. Patients will receive one pill po qd for 21 days, and next period should be started after 7 days.

DRUGMET

500mg po tid


Locations(2)

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Tenth People's Hospital of Tongji University

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05316935


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