RecruitingNot ApplicableNCT05945407

Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer

Establishment of a Network Platform for Fertility-sparing in Patients With Endometrial Cancer and Study on Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer.

Sponsor

Peking University People's Hospital

Enrollment

57 participants

Start Date

Aug 1, 2016

Study Type

INTERVENTIONAL

Conditions

Fertility Preservation Endometrial Neoplasms Endometrial Neoplasm Malignant Endometrial Neoplasm Malignant Stage I Carcinoma, Endometrioid

Summary

The goal of this clinical trial is to explore the feasibility and outcome of fertility-sparing therapy in Stage IA G1-G2 Endometrial Cancer with less than 1/2 myometrial invasion. Researchers will render participants indication-extended fertility-sparing therapy. Researchers will compare the myometrial invasion group with the no myometrial invasion group to see if it is possible to propose an extension indication of fertility-sparing therapy for endometrial cancer.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring a fertility-preserving treatment approach for young women with early-stage endometrial (uterine) cancer who want to have children in the future. Instead of a hysterectomy, the treatment uses progesterone-based hormone therapy to treat the cancer while keeping the uterus intact. **You may be eligible if...** - You are between 18 and 45 years old - You have early-stage endometrial cancer (Stage IA, Grade 1 or 2) confirmed by pathology - Imaging shows the cancer is confined to the uterine lining or invades less than half of the uterine wall - You strongly wish to preserve your fertility - You have signed informed consent **You may NOT be eligible if...** - You have any other type of cancer - You have a medical reason that prevents conservative (non-surgical) treatment - You have contraindications to progestin hormone therapy - You have conditions that make pregnancy unsafe or are judged unfit for pregnancy by researchers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTIndication-extended Fertility-sparing Therapy

Patients will receive medroxyprogesterone acetate ("FARLUTAL") 250-500mg/d or megestrol acetate ("YiLiZhi") 160-320mg/d orally. If there is no response after 6 months of treatment, change the regimen to levonorgestrel intrauterine system ("Mirena") and gonadotropin-releasing hormone agonist ("Leuprorelin", "Goserelin" or "Triptorelin") 3.75mg/28d injection subcutaneously. After complete remission, the same regimen will be used for consolidation treatment for another 1-3 months. Subsequently, if the patient has no intention of pregnancy, render maintenance treatment ("Mirena", "Progesterone", "Dydrogesterone", or combined oral contraceptive). Otherwise, the patient will be encouraged to conceive either by an expectation for 3-6 months, or by assisted reproductive technology. Indications for stopping fertility-sparing therapy: 1) disease progression; 2) no response after 9 months of treatment; 3) repeated recurrence; 4) no longer require sparing fertility; 5) serious adverse reactions.