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.

Peking University Third Hospital, Peking Union Medical College Hospital, Third Military Medical University, Tianjin Medical University General Hospital, Tongji Hospital, Qilu Hospital of Shandong University, Shengjing Hospital, Beijing Chao Yang Hospital, Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences

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.

The study population is patients with Stage IA endometrial adenocarcinoma with no myometrial invasion or less than 1/2 myometrial invasion. The sample size is 57 cases (Myometrial invasion group : No myometrial invasion group = 1 : 2). Follow up every 3-6 months until the end of the fifth year of treatment. The primary outcome measure is the complete remission rate after 9 months of treatment. Secondary outcome measures include complete remission rate (6 months/12 months after initial treatment), complete remission time, recurrence rate (1 year/2 years after complete remission), recurrence time, pregnancy rate (1 year after complete remission), pregnancy outcome, blood molecular biomarkers, pathological markers, adverse reactions, etc.

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

Fertility-sparing, Fertility-preserving, Endometrial Carcinoma, Endometrial Cancer, Indication Extension

Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor invades less than one half of the myometrium.

Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor is limited to the endometrium.

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.

No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.

No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.

No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.

After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs.

After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs.

Homeostasis model assessment of insulin resistance is used as an indicator to evaluate the level of insulin resistance.

Immunohistochemical analysis is used to assess the expression of Ki-67, ER/PR, p53, PTEN, and mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6).

Harmful reactions unrelated to the purpose of treatment occur during normal prevention, diagnosis, and treatment of diseases.

Inclusion Criteria: Stage IA (FIGO 2009) ; Pathological diagnosis: endometrial adenocarcinoma G1-G2; MRI or ultrasound: tumor limited to endometrium or invading less than 1/2 of myometrium； 18 years old ≤ Age ≤ 45 years old; With a strong desire for fertility preservation； Sign the informed consent. Exclusion Criteria: Complicated with any other malignancy； Contraindications to conservative treatment； Contraindications to progestin use; Contraindications to pregnancy, or judged by the researcher to be unfit for pregnancy or delivery.