The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma

NCT01820884Active, Not RecruitingNAINTERVENTIONAL

Summary

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.

Key Facts

Lead Sponsor

Ding Ma

Enrollment

240

Start Date

2012-11-01

Completion Date

2025-12-01

Study Type

INTERVENTIONAL

Official Title

The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma: A Multicenter, Prospective, Randomized Trial

Interventions

THTH/BSOBPLND

Conditions

Endometrial Neoplasms

Eligibility

Age Range

18 Years – 50 Years

Sex

FEMALE

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.

Outcome Measures

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

Locations

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

Qilu Hospital，Shandong University, Jinan, China

Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China

Linked Diseases

Endometrial Neoplasms

Endometrial Neoplasms — a type of gynecological cancer.

The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma