Clinical trial
GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients
Recruiting now · Phase 2, Phase 3 · 1 countries · Registry ID NCT05316935
What this study 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.
Basic eligibility
Full registry criteria
Treatments and study arms
GnRHa
Gonadotropin-releasing hormone analogue, intramuscular injection of 3.75mg will be given every 4 weeks , and the maximum using courses will be 6.
Letrozole 2.5mg
2.5mg po qd and no more than 24 weeks
Diane-35
Periodic use. Patients will receive one pill po qd for 21 days, and next period should be started after 7 days.
MET
500mg po tid
Primary outcomes
The cumulative 28-week CR rates will be calculated in two groups. Patients will be evaluated with an hysteroscopy every 12 weeks. For some may delay the evaluation as personal reasons, we define the primary outcome measure as complete response rates within 28 weeks of treatment.
Study locations
2 locations were listed when this page was built. The first 40 are shown.