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| Name | Class |
|---|---|
| Peking University Third Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Third Military Medical University | OTHER |
| Tianjin Medical University General Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myometrial invasion group | Experimental | Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor invades less than one half of the myometrium. |
|
| No myometrial invasion group | Other | Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor is limited to the endometrium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indication-extended Fertility-sparing Therapy | Combination Product | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Based on biological sex.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianliu Wang, Professor | Contact | 0086-010-88324381 | wangjianliu1203@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianliu Wang, Professor | Peking University People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hosoital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| OTHER |
| Tongji Hospital | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Shengjing Hospital | OTHER |
| Beijing Chao Yang Hospital | OTHER |
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | OTHER |
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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 |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D018269 | Carcinoma, Endometrioid |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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