Status:
RECRUITING
GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients
Lead Sponsor:
Xiaojun Chen
Conditions:
Endometrial Neoplasms
Atypical Endometrial Hyperplasia
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
There were more and more women with early endometrioid endometrial cancer (EEC) and atypical endometrial hyperplasia (EAH) who want to preserve fertility. Approximately 70% to 80% of females who meet ...
Eligibility Criteria
Inclusion
- Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove EAH or well-differentiated EEC G1 without myometrial invasion
- BMI\<30kg/m2
- No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound
- Using progestin, any of the following therapy, as first-line treatment:
- Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not
- Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not
- LNG-IUS inserted
- Progestin-insensitive:
- remained with stable disease after 7 months of progestin use
- did not achieve CR after 10 months of progestin use
- Have a desire for remaining reproductive function or uterus
- Good compliance with adjunctive treatment and follow-up
Exclusion
- Combined with severe medical disease or severely impaired liver and kidney function
- Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis
- Patients with other types of endometrial cancer or other malignant tumors of the reproductive system
- Patients with breast cancer or other hormone- dependent tumors or diseases that cannot be used with Diane-35, GnRHa, Letrozole or MET
- Strong request for uterine removal or other conservative treatment
- Known or suspected pregnancy
- Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
- Smoker(\>15 cigarettes a day)
Key Trial Info
Start Date :
July 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05316935
Start Date
July 13 2022
End Date
March 30 2027
Last Update
August 11 2025
Active Locations (2)
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1
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200011
2
Tenth People's Hospital of Tongji University
Shanghai, Shanghai Municipality, China