The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma

NCT ID: NCT01820884

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endometrial Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Total Hysterectomy (TH)

Patients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND).

Group Type EXPERIMENTAL

TH

Intervention Type PROCEDURE

Total hysterectomy

BPLND

Intervention Type PROCEDURE

bilateral pelvic and para-aortic lymph node dissection

TH and bilateral salpingo-oophorectomy (TH/BSO)

Patients may receive total hysterectomy, bilateral salpingo-oophorectomy (BSO) and bilateral pelvic and para-aortic lymph node dissection.

Group Type ACTIVE_COMPARATOR

TH/BSO

Intervention Type PROCEDURE

Total hysterectomy and bilateral salpingo-oophorectomy

BPLND

Intervention Type PROCEDURE

bilateral pelvic and para-aortic lymph node dissection

Interventions

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TH

Total hysterectomy

Intervention Type PROCEDURE

TH/BSO

Total hysterectomy and bilateral salpingo-oophorectomy

Intervention Type PROCEDURE

BPLND

bilateral pelvic and para-aortic lymph node dissection

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role collaborator

Ding Ma

OTHER

Sponsor Role lead

Responsible Party

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Ding Ma

Director of the department of Obstetrics and Gynecology, Tongji Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Beihua Kong, MD, PhD

Role: STUDY_CHAIR

Shandong University

Locations

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

Wuhan, Hubei, China

Site Status

Qilu Hospital,Shandong University

Jinan, Shandong, China

Site Status

Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2012-GYN/EC-02

Identifier Type: -

Identifier Source: org_study_id

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