Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer

Launched by FUDAN UNIVERSITY · Feb 15, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for young women with early-stage endometrial cancer, which is a type of cancer that starts in the lining of the uterus. The study is comparing the effectiveness of a combination of medications called Gonadotropin-releasing hormone agonists (GnRHa) and aromatase inhibitors (AIs) against traditional treatments like megestrol acetate or medroxyprogesterone acetate. The goal is to see if this new combination can help women maintain their fertility while effectively treating their cancer.

To be eligible for this trial, participants must be young women aged between 16 and 45 who have been diagnosed with early-stage endometrial cancer that does not show signs of spreading. They should also have a strong desire to preserve their ability to have children. Women who have other serious health issues, certain types of cancer, or who have had recent hormone treatments may not qualify. If enrolled, participants can expect regular follow-ups at the Obstetrics and Gynecology Hospital of Fudan University while receiving the study medications. This trial is currently recruiting participants, and it offers hope for those looking to balance cancer treatment with the desire for future pregnancies.

Gender

FEMALE

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)