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

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Non-obese Progestin-insensitive Early-stage Endometrial Cancer and Atypical Hyperplasia Patients With Conservative Treatment

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.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Fudan University (Academic / other)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT05316935 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are non-obese women diagnosed with progestin-insensitive early-stage endometrial cancer or atypical hyperplasia who desire to preserve their fertility.

Not a fit: Patients with severe medical conditions or significantly impaired liver function may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective and safer option for women with early-stage endometrial cancer seeking to maintain their reproductive capabilities.

How similar studies have performed: No similar studies have been found, making this approach novel and untested.

Eligibility 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)

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• 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

Conditions Endometrial Neoplasms; Atypical Endometrial Hyperplasia; Progesterone Resistance