The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma

N/AActive Not RecruitingNCT01820884

Ding Ma240 enrolled

Overview

This randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA endometrial carcinoma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Endometrial Neoplasms

Interventions

THPROCEDURE

Total hysterectomy

TH/BSOPROCEDURE

Total hysterectomy and bilateral salpingo-oophorectomy

BPLNDPROCEDURE

bilateral pelvic and para-aortic lymph node dissection

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * FIGO stage: ⅠA, endometrial carcinoma; * Female, Chinese women; * premenopausal women； * ≤ 50 years old; * Pathological diagnosis by curettage/hysteroscopy : G1 * No prior treatment; * Provide written informed consent. Exclusion Criteria: * The suspicious metastasis of ovarian; * Family history of ovarian cancer; * Suffering from other malignancies; * Concurrently participating in other clinical trials; * Unable or unwilling to sign informed consents; * Unable or unwilling to abide by protocol.

Locations (3)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Qilu Hospital，Shandong University

Jinan, Shandong, China

Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

Disease-free survival (DFS)

Time frame: 3-year DFS

Secondary Outcomes

Clinical gynecologic endocrine function

To observe the level of female hormone，i.e., estrogen, FSH, LH

Time frame: 1-year period

Quality of Life

Time frame: 3-year period

Overall Survival (OS)

Time frame: 3-year OS

Data from ClinicalTrials.gov

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