The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma (EC-02)

This study is currently recruiting participants.
Verified March 2013 by Huazhong University of Science and Technology
Sponsor:
Collaborators:
Shandong University
Huazhong University of Science and Technology
Zhejiang University
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01820884
First received: March 21, 2013
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Endometrial Neoplasms
Procedure: TH
Procedure: TH/BSO
Procedure: BPLND

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma: A Multicenter, Prospective, Randomized Trial

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Disease-free survival (DFS) [ Time Frame: 3-year DFS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical gynecologic endocrine function [ Time Frame: 1-year period ] [ Designated as safety issue: No ]
    To observe the level of female hormone,i.e., estrogen, FSH, LH

  • Quality of Life [ Time Frame: 3-year period ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: 3-year OS ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: November 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Total Hysterectomy (TH)
Patients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND).
Procedure: TH
Total hysterectomy
Procedure: BPLND
bilateral pelvic and para-aortic lymph node dissection
Active Comparator: 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.
Procedure: TH/BSO
Total hysterectomy and bilateral salpingo-oophorectomy
Procedure: BPLND
bilateral pelvic and para-aortic lymph node dissection

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01820884

Contacts
Contact: Danhui Weng, MD, PhD +862783662681 weng.dh@gmail.com

Locations
China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Danhui Weng, MD    +862783662681    weng.dh@gmail.com   
Principal Investigator: Changyu Wang, MD         
China, Shandong
Qilu Hospital,Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Xingsheng Yang, MD, Ph D    13791123129    xingshengyang@yahoo.com   
Principal Investigator: Xingsheng Yang, MD         
China, Zhejiang
Women's Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Yuyan Mao, MD    13989816955    maoyy3@yahoo.com.cn   
Principal Investigator: Yuyan Mao, MD         
Sponsors and Collaborators
Ding Ma
Shandong University
Huazhong University of Science and Technology
Zhejiang University
Investigators
Study Chair: Beihua Kong, MD, PhD Shandong University
  More Information

No publications provided

Responsible Party: Ding Ma, Director of the department of Obstetrics and Gynecology, Tongji Hospital, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01820884     History of Changes
Other Study ID Numbers: 2012-GYN/EC-02
Study First Received: March 21, 2013
Last Updated: March 26, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Endometrial Neoplasms
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 14, 2014