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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: cxjlhjj@163.com
• Phone: 8602133189900

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining GnRHa and Letrozole for Non-obese Patients with Endometrial Cancer

  This study is testing if a combination of GnRHa and letrozole can help non-obese patients with early-stage endometrial cancer keep their fertility when standard treatments haven't worked.

  Recruiting at 2 sites Phase 2/3 Fudan University · Shanghai, Shanghai Municipality and 1 other locations · NCT05316935

• Ocular Changes in People Using Tirzepatide or Semaglutide

  This study checks whether eye structure and blood vessels change in adults with obesity who are taking semaglutide or tirzepatide as part of routine care.

  Recruiting Istanbul University · Istanbul, Istanbul · NCT07924618

• Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes

  This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.

  Recruiting Pamukkale University · Denizli · NCT07924436

• Berobenatide for knee pain in adults who are overweight or with obesity

  This study tests berobenatide vs. placebo to see if it reduces knee pain and improves function while helping with weight in adults with knee osteoarthritis and overweight/obesity.

  Recruiting at 7 sites Phase 3 Pfizer · Tempe, Arizona and 39 other locations · NCT07919678

• Weekly berobenatide for knee osteoarthritis in adults who are overweight or obese

  This study tests whether weekly berobenatide helps reduce knee pain and improve function, while also affecting body weight, in adults with knee osteoarthritis who are overweight or obese (with or without type 2 diabetes).

  Recruiting Phase 3 Pfizer · Birmingham, Alabama and 3 other locations · NCT07915609

• Maridebart cafraglutide in people who switched from weekly GLP-1 receptor agonists

  This study tests how much maridebart cafraglutide appears in the blood after people with overweight or obesity switch from weekly GLP-1 receptor agonists.

  Recruiting at 9 sites Phase 1 Amgen · Phoenix, Arizona and 8 other locations · NCT07908316

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.