GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients

Launched by XIAOJUN CHEN · Apr 22, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for women with a specific type of endometrial cancer called endometrial endometrioid carcinoma (EEC), particularly those who are obese and not responding to traditional hormone therapies. The study is testing a combination of two medications: GnRHa (a hormone therapy) and letrozole (a medication that helps block estrogen), to see if they can effectively treat these patients. The trial is currently recruiting participants aged between 65 and 74 who have a confirmed diagnosis of well-differentiated EEC without deep tissue invasion and have a body mass index (BMI) of 30 or higher.

To be eligible for this trial, women must have previously used hormone treatments without success, meaning their cancer did not improve after several months on medication. Participants should also want to keep their uterus for potential future pregnancies. If you join the study, you will receive the new treatment and regular follow-up care to monitor your health. However, this trial is not for everyone. Women with severe health issues, certain other types of cancer, or those who are pregnant are not eligible. If you are interested in learning more about this study, it’s a good idea to discuss it with your healthcare provider.

Gender

FEMALE

Eligibility criteria

• 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)