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Effect of Fertility-sparing Therapy of Early Endometrial Cancer (ECFerSp)

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ClinicalTrials.gov Identifier: NCT03538704
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Collaborators:
Peking University First Hospital
Peking University Third Hospital
Tianjin Medical University General Hospital
Maternal and Child Health Hospital of Hubei Province
First Affiliated Hospital, Sun Yat-Sen University
Qilu Hospital of Shandong University
Information provided by (Responsible Party):
Peking University People's Hospital

Tracking Information
First Submitted Date  ICMJE March 14, 2018
First Posted Date  ICMJE May 28, 2018
Last Update Posted Date May 28, 2018
Actual Study Start Date  ICMJE January 1, 2015
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
Complete response rate [ Time Frame: through study completion, an average of 3 months ]
Histologically shows absence of pathological hyperplasia or carcinoma.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
Pregnancy rate [ Time Frame: through study completion, an average of 3 months ]
Pregnancy test shows pregnancy after complete response.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 24, 2018)
Recurrence rate [ Time Frame: through study completion, an average of 3 months ]
Pathology shows atypical hyperplasia or carcinoma again after complete response.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Fertility-sparing Therapy of Early Endometrial Cancer
Official Title  ICMJE Effect of Fertility-sparing Therapy of Early Endometrial Cancer
Brief Summary The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer.
Detailed Description This is a prospective, multi center, open, randomized, controlled clinical trial. All endometrial cancer (EC) or atypical hyperplasia (AH) patients who met the fertility-sparing indications in the hospitals involved in this study were recruited. Then the investigators conducted assessment, treatment and follow up according to the standard procedure. General information, therapeutic regimen, side effects, oncological and pregnant results were collected for risk factors analysis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Endometrial Cancer
  • Fertility
Intervention  ICMJE Drug: Metformin
Metformin is given to patients 1-1.5g/d.
Study Arms  ICMJE
  • Experimental: BMI≥25 group with metformin
    Patients with BMI≥25kg/m2 in the experimental group are treated with medroxyprogesterone acetate (MPA) 0.25g/d plus metformin and are followed-up of baseline data, hormone levels,
    Intervention: Drug: Metformin
  • No Intervention: BMI≥25 group without metformin
    Patients with BMI≥25kg/m2 in the none intervention group are treated with MPA 0.25g/d alone and are followed-up of baseline data, hormone levels, and endometrial pathology every 3 months until 12 months.
Publications * Gallos ID, Yap J, Rajkhowa M, Luesley DM, Coomarasamy A, Gupta JK. Regression, relapse, and live birth rates with fertility-sparing therapy for endometrial cancer and atypical complex endometrial hyperplasia: a systematic review and metaanalysis. Am J Obstet Gynecol. 2012 Oct;207(4):266.e1-12. doi: 10.1016/j.ajog.2012.08.011. Epub 2012 Aug 10. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ages of no more than 40
  • with a strong desire of fertility preservation
  • International Federation of Gynecology and Obstetrics (FIGO) 2009 stage Ⅰa grade 1~2 with lesion confined in endometrium
  • pathology expression of progestin receptors (PRs) and estrogen receptors

Exclusion Criteria:

  • not eligible for pregnancy or delivery
  • evidence of suspected extrauterine or distant metastasis
  • complicated with any other malignancy
  • severe medical complications
  • contraindication of oral progestin
  • uncontrolled epilepsy, central nervous system disease or mental disorder history in patients which Influence clinical research compliance judging by the researcher.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jianliu Wang, Professor 010-88324381 wangjianliu1203@163.com
Contact: Rong Zhou, Professor 010-88324350 zhourong@pku.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03538704
Other Study ID Numbers  ICMJE 2018ECFerSp
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peking University People's Hospital
Study Sponsor  ICMJE Peking University People's Hospital
Collaborators  ICMJE
  • Peking University First Hospital
  • Peking University Third Hospital
  • Tianjin Medical University General Hospital
  • Maternal and Child Health Hospital of Hubei Province
  • First Affiliated Hospital, Sun Yat-Sen University
  • Qilu Hospital of Shandong University
Investigators  ICMJE
Study Chair: Jianliu Wang, Professor Department of Obstetrics and Gynecology, Peking University People's Hospital
PRS Account Peking University People's Hospital
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP