Clinical trial

GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients

Recruiting now · Phase 2, Phase 3 · 1 countries · Registry ID NCT06379113

Recruiting nowPhase 2, Phase 3Interventional

What this study is about

To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC patients.

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, Obesity

Full registry criteria

Inclusion Criteria: * Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove 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 GnRHa or Letrozole * 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

GnRH antagonist

Drug

Gonadotropin-releasing hormone analogue, intramuscular injection of 3.75mg will be given every 4 weeks, and the maximum treatment courses will be 6. If the patient get CR within 6 courses, another 2 courses will be used as consolidation therapy.

Letrozole 2.5mg

Drug

2.5mg po qd.

Primary outcomes

Complete response rates within 28 weeks of treatmentUp to 28 weeks

The cumulative 28-week CR rates will be calculated in two groups. Patients will be evaluated with an hysteroscopy every 12 to 16 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, China
Xiaojun ChenContact
Tenth People's Hospital of Tongji University🇨🇳 Shanghai, Shanghai Municipality, China
Weina WangContact