Combining GnRHa and Letrozole for Non-obese Patients with 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 clinical trial investigates the effectiveness of combining GnRHa and letrozole compared to Diane-35 and metformin in treating non-obese patients with progestin-insensitive early-stage endometrial cancer and atypical hyperplasia who wish to preserve their fertility. The study aims to provide a conservative treatment option for patients who have not responded to standard progestin therapy. It will involve a single-center, prospective pilot design, enrolling patients diagnosed through hysteroscopy or dilatation and curettage. The trial focuses on patients with a BMI under 30 kg/m² to minimize risks associated with obesity.

Why it matters

Who can join: the full rules

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)

Where it's running

• Obstetrics and Gynecology Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• Tenth People's Hospital of Tongji University
  Shanghai, Shanghai Municipality, 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.

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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.