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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
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.
Peking University People's Hosoital
Beijing, Beijing Municipality, China
RECRUITINGcomplete remission rate
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
Time frame: 9 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.
Time frame: 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.
Time frame: 12 months after initial treatment
complete remission time
Time required to achieve complete remission.
Time frame: 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.
Time frame: 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.
Time frame: 2 years after complete remission
recurrence time
Time of recurrence after complete remission.
Time frame: 2 years after complete remission
pregnancy rate
A pregnancy test shows pregnancy after complete remission.
Time frame: 1 year after complete remission
pregnancy time
Time of pregnancy.
Time frame: 1 year after complete remission
live birth rate
The live birth rate is defined as the ratio of live births to pregnancies.
Time frame: 1 year after pregnancy
CA125
Used as a tumor marker for disease monitoring.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: every 3-6 months until 5 years after initial treatment
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