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

Recruiting nowPhase 2, Phase 3Interventional

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years
SexFemale
Healthy volunteersNot accepted
ConditionEndometrial Neoplasms, Atypical Endometrial Hyperplasia, Progesterone Resistance

Full registry criteria

Inclusion Criteria: * 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: 1. Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not 2. Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not 3. LNG-IUS inserted * Progestin-insensitive: 1. remained with stable disease after 7 months of progestin use 2. 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 Criteria: * 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)

Treatments and study arms

GnRHa

Drug

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

Drug

2.5mg po qd and no more than 24 weeks

Diane-35

Drug

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

MET

Drug

500mg po tid

Primary outcomes

Complete response rates within 28 weeks of treatmentFrom date of randomization until the date of CR, assessed up to 28 weeks

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.

Obstetrics and Gynecology Hospital, Fudan University🇨🇳 Shanghai, Shanghai Municipality, China
Xiaojun Chen, PhDContact
Bingyi Yang, MDContact
Xiaojun ChenPrincipal Investigator
Tenth People's Hospital of Tongji University🇨🇳 Shanghai, Shanghai Municipality, China
Weina WangContact