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Terminated
NCT05316467
Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma
Conditions: Endometrial Carcinoma, Obese, Overweight, Fertility Issues
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 8
Sponsor: Xiaojun Chen
Location: Obstetrics and Gynecology Hospital, Fudan University Shanghai Shanghai Municipality
Summary
To investigate the efficacy of weight management plus megestrol acetate in obese patients with early endometrioid carcinoma(EEC)asking for fertility-sparing treatment
Eligibility Criteria
Inclusion Criteria:
1. 18 years≤age≤45years
2. BMI (body mass index) ≥24kg/m2
3. Consent informed and signed
4. Pathologically confirmed as endometrial carcinoma Patients with endometrial specimens obtained by endometrial biopsy, diagnostic curettage or hysteroscopy and diagnosed histologically as endometrioid carcinoma, G1. If specimens are from other hospitals, they must be counseled or reconfirmed by the Department of Pathology of the Obstetrics and Gynecology Hospital of Fudan University.
5. Imaging Assessment Enhanced MRI of the pelvis and enhanced CT of the upper abdomen must be performed in 2 weeks prior to starting treatment to assess the lesions confined to the endometrial layer without clear myometrial infiltration or extrauterine involvement.
6. Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements.
7. Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time.
Exclusion Criteria:
1. Patients with non-endometrioid endometrial carcinoma, endometrioid endometrial carcinoma G2/G3 or other malignant tumors of the reproductive system; imaging suggests myometrial invasion, cervical involvement or extra-uterine involvement.
2. Combined with severe medical disease or liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels elevate to 3 times or more of the upper limit of normal, kidney dysfunction (creatinine clearance \
Source: ClinicalTrials.gov (NCT05316467). StuddyBuddy aggregates publicly available trial information.