None listed
Conditions
Interventions
Drug : Patients take 500 mg of MPA (Farlutal® Tablets 500 mg) in once oral dose. The MPA administration dose cannot be reduced, such as adverse events. Patients will be performed a D&C every 8 weeks u
Sponsors
Masan Samsung Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Intrauterine recurrence of AEH or stage IA grade 1 endometrioid endometrial cancer without myometrial invasion or extrauterine spread confirmed by imaging tests after complete remission with the previous fertility-sparing high-dose progestin therapy. The number of recurrences should be up to twice. 2)Histologically confirmed AEH or endometrioid carcinoma Grade 1 via the most recent D&C or endometrial biopsy (EMB). Histologically confirmed benign or lesions with less than AEH by recent D&C would be eligible provided that confirmed AEH or endometrioid carcinoma Grade 1 by the most recent EMB. 3)After completion of previous treatment, there must be at least one instance where no lesions of AEH or higher are detected in the endometrial biopsy (EMB). 4)Absence of myometrial invasion, cervical stromal invasion, or extrauterine lesions confirmed via pelvic magnetic resonance imaging (MRI) at the time of recurrence. 5)Absence of extrauterine lesions, such as lymph node or distant metastases, confirmed via pelvic MRI at the time of recurrence. 6)Patients aged 20 to 42 years at the time of recurrence. 7)Patients who wish to preserve fertility. 8)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0–1. 9)Patients with normal hematological findings, renal function, and liver function. The following tests must be conducted within 14 days prior to enrollment: Neutrophil count: =1,500/mm³ Hemoglobin: =9.0 g/dL Platelet count: =100,000/mm³ Aspartate aminotransferase (AST) (glutamic-oxaloacetic transaminase [GOT]) and alanine aminotransferase (ALT) (glutamic pyruvic transaminase [GPT]): =100 U/L Total bilirubin: =1.5 mg/dL Serum creatinine: =1.5 mg/dL D-dimer: =0.5 µg/mL 10)Signed informed consent for participation in the study obtained from the patient. 11)Patients who agree to use contraception during the study period (Contraception period: during administration of the investigational drug or for at least 3 months after discontinuation; contraception methods include condoms, withdrawal, etc.).
Exclusion criteria
Exclusion criteria: 1)The recurrent lesion is grade =2 endometrioid carcinoma, non-endometrioid carcinoma, or endometrial hyperplasia without atypia. 2)Cases where the histological type has worsened compared to before the initial hormone therapy (e.g., patients who initially had AEH before treatment but recurred as endometrioid carcinoma Grade 1 afterward). 3)A third or more recurrence (*). 4)Patients who have been enrolled to this trial once. 5)Patients who have not been confirmed of pathological disappearance of the lesion observed via D&C after the previous treatment (pathological disappearance is defined as disappearance of endometrial hyperplasia). 6)Patients who have not been able to diagnosed with accurate evaluation of myometrium invasion by pelvic MRI due to uterine abnormalities (adenomyosis, uterine fibroid, etc.) 7)Patients with a history or evidence of thromboembolism (cerebral infarction, myocardial infarction, thrombophlebitis, arteriosclerosis). 8)Patients with Body Mass Index (BMI) = 40 kg/m². 9)Patients with a history of hypersensitivity to progestins (allergic history of progestins). 10)Patients with cardiac disease (valvular heart disease, atrial fibrillation, severe heart failure, etc.) 11)Peripheral neuropathy (motor and/or sensory) of grade =2 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0). 12)Simultaneous or metachronous (within 5 years) double or multiple cancers, except carcinoma in situ. 13)Patients with a history of chemotherapy or radiotherapy. 14)Patients with serious hepatic dysfunction. 15)Patients with hypercalcemia. 16)Patients with poorly controlled diabetes and/or hypertension. 17)Patients who have been administered a hormonal therapy and cannot stop receiving it (progestins, estrogens, corticosteroids, etc.) 18)Patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 19)Patients with a history of hypersensitivity to the investigational drug or its components. 20)Pregnant or potentially pregnant women, and lactating women. 21)Patients who cannot be performed MRI and CT. 22)Patients who were judged as not fit to participate in this study by a primary physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year recurrence-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| recurrence-free survival, overall survival, complete remission rate, pregnancy rate, adverse events, number of dilation and curettage procedures (D&Cs), hysterectomy rate, infertility treatment rate and procedure, perinatal and pregnancy prognosis, family history of cancer, etc. | — |
Countries
Korea, Republic of
Contacts
Public ContactEunsun Lee
KGOG(Korea Gynecologic Oncology Group)
Outcome results
None listed