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Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01968317
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : October 30, 2017
Sponsor:
Collaborators:
Fudan University
Shanghai 6th People's Hospital
Zhejiang Cancer Hospital
Shanghai Changning Maternity & Infant Health Hospital
Information provided by (Responsible Party):
Xiaojun Chen, Fudan University

Tracking Information
First Submitted Date  ICMJE October 16, 2013
First Posted Date  ICMJE October 24, 2013
Last Update Posted Date October 30, 2017
Study Start Date  ICMJE October 2013
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2014)
Pathological response rate [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2013)
Pathological response rate [ Time Frame: 16 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2013)
  • Toxicity evaluation [ Time Frame: up to 2 years after the treatment for each patient ]
  • Rate of relapse [ Time Frame: up to 2 years after the treatment for each patient ]
  • Rate of pregnancy [ Time Frame: up to 2 years after the treatment for each patient ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma
Official Title  ICMJE Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma
Brief Summary The purpose of this study is to see if megestrol acetate plus metformin will be more effective in returning the endometrial tissue to a normal state than megestrol acetate alone in patients with endometrial atypical hyperplasia or early stage endometrial adenocarcinoma.
Detailed Description

After diagnosed of endometrial atypical hyperplasia(EAH) or type I endometrial cancer(EC) by dilatation and curettage (D&C) or hysteroscopy, patients will be enrolled. Age, waist circumstances, blood pressure, basic history of infertility, blood pressure, serum lipid level and side effects will be collected. Blood tests, including triglycerides, high density lipoprotein-cholesterol, fasting blood glucose, liver and kidney function will be performed before treatment to evacuate their metabolic conditions.

Patients are randomized to 1 of 2 treatment groups. Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months on Arm I. Patients will receive megestrol acetate 160 mg PO daily for 3 months on Arm II. Then an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded. For patients with EAH, complete response (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response (PR) is defined as regression to simple or complex hyperplasia without atypia; no response (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of endometrial cancer in patients. EAH after treatment will be defined as PR in patients with EC. Continuous therapies will be needed in PR, NR or PD.

After completion of study treatment, 3 months of maintenance treatment will be recommended for patients with CR, and they will be followed up for 2 years.

In addition, we've already had a pilot study in 19 patients primarily diagnosed of endometrial atypical hyperplasia from August 2012 to April 2013. 10 patients were in Arm I and 9 patients were in Arm II. Metabolic syndrome were evaluated among all subjects. After treatment, megestrol acetate plus metformin worked better than megestrol acetate alone. But two arms showed no difference in NR patients, which may suggest metformin just worked as an antitumor drug more than an insulin sensitizer. More supportive researches are needed to verify it.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Endometrial Atypical Hyperplasia
  • Endometrial Adenocarcinoma
Intervention  ICMJE
  • Drug: Megestrol acetate and metformin
    Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months.
    Other Names:
    • Megestrol acetate: Megace
    • Metformin: Fortamet, Glucophage
  • Drug: Megestrol acetate
    Patients will receive megestrol acetate 160 mg by mouth daily for 3 months.
    Other Name: Megestrol acetate: Megace
Study Arms  ICMJE
  • Experimental: Megestrol acetate and metformin
    Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months.Then an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.
    Intervention: Drug: Megestrol acetate and metformin
  • Experimental: Megestrol acetate
    Patients will receive megestrol acetate 160 mg by mouth daily for 3 months.Then an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.
    Intervention: Drug: Megestrol acetate
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2014)
150
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2013)
106
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be between the ages of 18-45 years old
  • Primarily have a confirmed diagnosis of endometrial atypical hyperplasia based upon D&C or hysteroscopy

    • OR primarily have a confirmed diagnosis of endometrial adenocarcinoma(G1, low tumor grade), based upon D&C or hysteroscopy, and three MRI parameters shows there's no myometrial invasion, extension beyond corpus, or enlarged lymph nodes
  • Have a desire for remaining reproductive function or uterus
  • Need to be able to undergo correlative treatment and follow-up

Exclusion Criteria:

  • Have a history of serious liver or renal dysfunction
  • Have a confirmed diagnosis of malignant tumor in genital system
  • Have taken oral contraceptive or other medicine for the treatment of endometrial hyperplasia in the past 6 months
  • Ask for removal of the uterus or other conservative treatment
  • serum CA-125 > 35 Um/L
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01968317
Other Study ID Numbers  ICMJE 134119a4500
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiaojun Chen, Fudan University
Study Sponsor  ICMJE Xiaojun Chen
Collaborators  ICMJE
  • Fudan University
  • Shanghai 6th People's Hospital
  • Zhejiang Cancer Hospital
  • Shanghai Changning Maternity & Infant Health Hospital
Investigators  ICMJE
Study Chair: Xiaojun Chen, PhD Obstetrics & Gynecology Hospital of Fudan University
PRS Account Fudan University
Verification Date October 2017

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