GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients

Launched by XIAOJUN CHEN · Apr 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a combination treatment for women with early-stage endometrial cancer or atypical hyperplasia who have not responded to standard hormone therapies. The researchers want to see if using a drug called GnRHa together with letrozole is more effective than another treatment option, Diane-35 combined with metformin. The trial is currently looking for participants who are female, between the ages of 65 and 74, and have a specific type of cancer diagnosis confirmed through a procedure called hysteroscopy. To be eligible, participants should have a body mass index (BMI) under 30 and should not have signs of cancer spreading beyond the uterus.

Women who join this trial can expect to receive close monitoring and follow-up care as part of the study. It's important to note that candidates should not have serious medical conditions, other types of cancer, or a strong desire for a hysterectomy (removal of the uterus). The goal of this trial is to explore a less invasive treatment option for women who wish to preserve their reproductive function while addressing their cancer.

Gender

FEMALE

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)