Combining GnRHa and Letrozole for Young Women with Early Endometrial Cancer

Gonadotropin-releasing Hormone Agonist Combined With Letrozole Compared With Megestrol Acetate or Medroxyprogesterone Acetate Alone as Fertility-sparing Treatment in Early Endometrial Cancer

This study is testing if a combination of hormone treatments can help young women with early endometrial cancer keep their fertility while effectively treating the cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Fudan University (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05247268 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Gonadotropin-releasing hormone analogue (GnRHa) combined with aromatase inhibitors (AIs) in treating young women diagnosed with early endometrial carcinoma who wish to preserve their fertility. Participants aged 18-45 will be randomly assigned to receive either the GnRHa plus letrozole or standard treatment with megestrol acetate or medroxyprogesterone acetate. The study will monitor treatment responses through regular hysteroscopies and assess various outcomes, including complete response rates and potential side effects over a 28-week period.

Who should consider this trial

Good fit: Ideal candidates are young women aged 18-45 with a confirmed diagnosis of early-stage endometrial cancer who desire to preserve their reproductive function.

Not a fit: Patients with signs of myometrial invasion, extrauterine metastasis, or recurrent endometrial cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective fertility-sparing option for young women with early endometrial cancer.

How similar studies have performed: While similar approaches have been explored, this specific combination of GnRHa and AIs for fertility preservation in early endometrial cancer is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Consent informed and signed
* Primarily have a confirmed diagnosis of early-stage endometrial cancer (endometrioid, grade I, without myometrial inva- sion) ) based upon endometrial biopsy, diagnostic curettage or hysteroscopy
* No signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS)
* Have a strong desire for remaining reproductive function or uterus
* Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time

Exclusion Criteria:

* Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis
* Recurrent endometrial cancer
* Combined with severe medical disease or severely impaired liver and kidney function
* Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; patients with breast cancer or other hormone- dependent tumors that cannot be used with progesterone
* Those who require hysterectomy or other methods other than conservative treatment with drugs
* Known or suspected pregnancy
* Contraindication for Medroxyprogesterone Acetate, Megestrol Acetate, Triprorelin Acetate, Letrozole or pregnancy
* Hormone treatment within 3 months before entering the trial;
* 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

• Obstetrics and Gynecology Hospital, Fudan University — Shanghai, China (RECRUITING)

Conditions: Endometrial Neoplasm Malignant Stage I, early endometrial carcinoma, fertility-preserving treatment, gonadotropin-releasing hormone analogue, aromatase inhibitors