Carcinoma, Endometrioid, Endometrial Neoplasm Malignant, Endometrial Neoplasm Malignant Stage I, Endometrial Neoplasms, Fertility Preservation
Conditions
Keywords
Fertility-sparing, Fertility-preserving, Endometrial Carcinoma, Endometrial Cancer, Indication Extension
Brief 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.
Detailed description
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.
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.
Sponsors
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 of China Academy of Chinese Medical Sciences
Peking University People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete remission rate | 9 months after initial treatment | No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complete remission time | 12 months after initial treatment | Time required to achieve complete remission. |
| recurrence rate | 1 year after complete remission | After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs. |
| recurrence time | 2 years after complete remission | Time of recurrence after complete remission. |
| pregnancy rate | 1 year after complete remission | A pregnancy test shows pregnancy after complete remission. |
| pregnancy time | 1 year after complete remission | Time of pregnancy. |
| complete remission rate | 6 months after initial treatment | No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor. |
| CA125 | every 3-6 months until 5 years after initial treatment | Used as a tumor marker for disease monitoring. |
| HOMA-IR | every 3-6 months until 5 years after initial treatment | Homeostasis model assessment of insulin resistance is used as an indicator to evaluate the level of insulin resistance. |
| pathological markers | every 3-6 months until 5 years after initial treatment | Immunohistochemical analysis is used to assess the expression of Ki-67, ER/PR, p53, PTEN, and mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6). |
| adverse reactions | every 3-6 months until 5 years after initial treatment | Harmful reactions unrelated to the purpose of treatment occur during normal prevention, diagnosis, and treatment of diseases. |
| live birth rate | 1 year after pregnancy | The live birth rate is defined as the ratio of live births to pregnancies. |
Countries
China
Contacts
Primary ContactJianliu Wang, Professor
Outcome results
None listed