The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma

NCT01820884Active, Not RecruitingNAINTERVENTIONAL

Summary

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