Study of fertility-sparing management using high-dose oral progestin in young women with stage I endometrial adenocarcinoma with grade 2 differentiation or superficial myometrial invasio

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0003226
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

1) Only 20-40 year old women
2) a previously untreated, histologically diagnosed endometrial cancer
3) Patients who were diagnosed with endometrioid adenocarcinoma
4) MRI in which the lesion is confined to the uterine corpus only (Stage IA)
5) If one of the following criteria is met:
a) when the grade 1, the myometrial invasion by MRI and the depth of invasion is <1/2, or
b) If the grade 2 and the myometrial invasion is absent or the myometrial invasion of the uterus is <1/2
6) Patients without evidence of complex ovarian tumors on MRI *
7) Patients without evidence of pelvic lymph node and / or para-aortic lymph node enlargement (short diameter> 1 cm) on MRI *
8) Women who want to preserve ovaries strongly
9) GOG performance status 0-2 patients
10) Appropriate organ function
WBC = 3,000/mm3 Platelets = 100,000/mm3 Creatinine = 2 mg/dL
Bilirubin = 1.5 x institutional upper limit normal
SGOT, SGPT, and ALP = 3 x institutional upper limit normal
11) Patients who voluntarily signed their written consent
* If the cell grade is 1 and there is no myometrial invasion by MRI, participation is not possible.
* If there is a complex ovarian tumor on the MRI, or if the pelvic or para-aortic lymph node enlargement (short diameter> 1 cm) is present, there is no malignant tumor of the ovary or metastasis or lymph node metastasis in the histological diagnosis by laparoscopic surgery. If so, participation in the test is possible.

Exclusion Criteria

1) Patients with a history of breast cancer or who were diagnosed with breast cancer during the study
2) patients who had other cancer or who were treated for cancer within 5 years except for non-melanoma skin cancer
3) Pregnant or lactating women
4) Patients with a history of thrombophlebitis, thromboembolism, or cerebrovascular disease
5) Patients with severe underlying disease or complications
6) Patients with a history of acute or chronic liver disease
7) Patients with a history of radiation therapy in the peritoneal or pelvic region
8) Patients with a history of chemotherapy for peritoneal or pelvic tumor

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The presence of endometrial cancer is confirmed by D&C (Dilation and curettage) and the response rate of the treatment is analyzed by the difference of the result;The presence of endometrial cancer is confirmed by MRI(magnetic resonance imaging)and the response rate of the treatment is analyzed by the difference of the result

Secondary Outcome Measures

Name	Time	Method
disease -free survival : it analyzes survival outcome using the kaplan-meir method;fertility-outcomes : it analyzes menstruation, pregnancy rate, birth rate, abortion rate, and premature birth rate;Evaluate side effects of high-concentration MPA.;predictive and prognostic biomarker and clincopatholgic factors which can predict response to oral MPA and recurrence : chi-square test and logistic regression;Patient-reported outcomes (PRO) : It analyzed by the EORTC QLQ-C30, EORTC QLQ-CX24)