Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

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

Intervention / Treatment
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* Combination Product: Indication-extended Fertility-sparing Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myometrial invasion group<br>Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor invades less than one half of the myometrium. | Combination Product: Indication-extended Fertility-sparing Therapy<br>* 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.<br>|
| Other: No myometrial invasion group<br>Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor is limited to the endometrium. | Combination Product: Indication-extended Fertility-sparing Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate | No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor. | 9 months after initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate | No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor. | 6 months after initial treatment | 
| complete remission rate | No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor. | 12 months after initial treatment | 
| complete remission time | Time required to achieve complete remission. | 12 months after initial treatment | 
| recurrence rate | After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs. | 1 year after complete remission | 
| recurrence rate | After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs. | 2 years after complete remission | 
| recurrence time | Time of recurrence after complete remission. | 2 years after complete remission | 
| pregnancy rate | A pregnancy test shows pregnancy after complete remission. | 1 year after complete remission | 
| pregnancy time | Time of pregnancy. | 1 year after complete remission | 
| live birth rate | The live birth rate is defined as the ratio of live births to pregnancies. | 1 year after pregnancy | 
| CA125 | Used as a tumor marker for disease monitoring. | every 3-6 months until 5 years after initial treatment | 
| HOMA-IR | Homeostasis model assessment of insulin resistance is used as an indicator to evaluate the level of insulin resistance. | every 3-6 months until 5 years after initial treatment | 
| pathological markers | Immunohistochemical analysis is used to assess the expression of Ki-67, ER/PR, p53, PTEN, and mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6). | every 3-6 months until 5 years after initial treatment | 
| adverse reactions | Harmful reactions unrelated to the purpose of treatment occur during normal prevention, diagnosis, and treatment of diseases. | every 3-6 months until 5 years after initial treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fertility-sparing, Fertility-preserving, Endometrial Carcinoma, Endometrial Cancer, Indication Extension