Using GnRHa and Letrozole for Obese Women with Progestin-Insensitive Endometrial Cancer

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Obese Progestin-insensitive Early-stage Endometrial Cancer Patients With Conservative Treatment

This study is testing a new treatment combining GnRH antagonist and letrozole to see if it helps obese women with a specific type of endometrial cancer that hasn't responded to standard therapy.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Fudan University (other)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT06379113 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of a combination treatment of GnRH antagonist and letrozole in obese women diagnosed with progestin-insensitive early endometrioid endometrial cancer (EEC) and atypical endometrial hyperplasia (EAH). The trial aims to improve treatment outcomes for patients who have not responded to standard progestin therapy, which often leads to prolonged treatment durations and associated side effects. The primary goal is to assess the cumulative complete response rate after 28 weeks of treatment, while secondary endpoints include monitoring adverse events, recurrence rates, and quality of life. This pilot study will enroll patients based on specific eligibility criteria, including a confirmed diagnosis and a BMI of 30 or higher.

Who should consider this trial

Good fit: Ideal candidates for this study are obese women (BMI ≥ 30 kg/m2) with a confirmed diagnosis of progestin-insensitive early endometrioid endometrial cancer or atypical endometrial hyperplasia.

Not a fit: Patients with severe medical conditions or significant liver and kidney impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and less burdensome option for obese women with progestin-insensitive endometrial cancer, potentially preserving their fertility.

How similar studies have performed: This approach is novel and has not been tested in similar studies, making it a potentially groundbreaking investigation.

Eligibility 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)

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Tenth People's Hospital of Tongji University — Shanghai, Shanghai Municipality, China (RECRUITING)
• Obstetrics and Gynecology Hospital, Fudan University — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Xiaojun Chen, PhD

Conditions: Endometrial Neoplasms, Atypical Endometrial Hyperplasia, Progesterone Resistance, Obesity