Actively Recruiting
GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients
Led by Xiaojun Chen · Updated on 2025-08-11
80
Participants Needed
2
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis by hysteroscopy of atypical endometrial hyperplasia or well-differentiated early-stage endometrial cancer without myometrial invasion
- Body mass index (BMI) less than 30 kg/m2
- No signs of extrauterine disease on enhanced MRI, CT, or ultrasound
- Previous first-line progestin treatment with megestrol acetate (≥160 mg daily), medroxyprogesterone acetate (≥250 mg daily), or levonorgestrel intrauterine system (LNG-IUS)
- Progestin-insensitive defined as stable disease after 7 months or no complete response after 10 months of progestin therapy
- Desire to preserve reproductive function or uterus
- Good compliance with treatment and follow-up
You will not qualify if you...
- Severe medical illnesses or significantly impaired liver or kidney function
- Endometrial cancer with suspected myometrial invasion or extrauterine spread
- Other types of endometrial cancer or malignant tumors of the reproductive system
- Breast cancer or other hormone-dependent tumors that contraindicate use of Diane-35, GnRHa, letrozole, or metformin
- Strong desire for hysterectomy or alternative conservative treatment
- Known or suspected pregnancy
- Acute severe diseases such as stroke, heart attack, or history of thrombosis
- Smoking more than 15 cigarettes per day
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
2
Tenth People's Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
X
Xiaojun Chen, PhD
CONTACT
B
Bingyi Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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