Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Non-obese Progestin-insensitive Early-stage Endometrial Cancer and Atypical Hyperplasia Patients With Conservative Treatment
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Obstetrics and Gynecology Hospital, Fudan University
RECRUITING
Shanghai
Tenth People's Hospital of Tongji University
RECRUITING
Shanghai
Contact Information
Primary
Xiaojun Chen, PhD
cxjlhjj@163.com
8602133189900
Backup
Bingyi Yang
xiaomihaoku@163.com
8602133189900
Time Frame
Start Date:2022-07-13
Estimated Completion Date:2027-03-30
Participants
Target number of participants:80
Treatments
Experimental: Non-obese EEC group (G)
20 non-obese EEC patients will be randomized to GnRHa + Letrozole group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.
Experimental: Non-obese EEC group (D)
20 non-obese EEC patients will be randomized to Diane-35 + metformin group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.
Experimental: Non-obese EAH group (G)
20 non-obese EAH patients will be randomized to GnRHa + Letrozole group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.
Experimental: Non-obese EAH group (D)
20 non-obese EAH patients will be randomized to Diane-35 + metformin group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.