- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03538704
Effect of Fertility-sparing Therapy of Early Endometrial Cancer (ECFerSp)
May 24, 2018 updated by: Peking University People's Hospital
The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer.
Study Overview
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
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jianliu Wang, Professor
- Phone Number: 010-88324381
- Email: wangjianliu1203@163.com
Study Contact Backup
- Name: Rong Zhou, Professor
- Phone Number: 010-88324350
- Email: zhourong@pku.edu.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100044
- Recruiting
- Peking University People's Hospital
-
Contact:
- Jianliu Wang, Professor
- Phone Number: 010-88324381
- Email: wangjianliu1203@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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,
|
Metformin is given to patients 1-1.5g/d.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete response rate
Time Frame: through study completion, an average of 3 months
|
Histologically shows absence of pathological hyperplasia or carcinoma.
|
through study completion, an average of 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pregnancy rate
Time Frame: through study completion, an average of 3 months
|
Pregnancy test shows pregnancy after complete response.
|
through study completion, an average of 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence rate
Time Frame: through study completion, an average of 3 months
|
Pathology shows atypical hyperplasia or carcinoma again after complete response.
|
through study completion, an average of 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Jianliu Wang, Professor, Department of Obstetrics and Gynecology, Peking University People's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Anticipated)
March 31, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
March 14, 2018
First Submitted That Met QC Criteria
May 24, 2018
First Posted (Actual)
May 29, 2018
Study Record Updates
Last Update Posted (Actual)
May 29, 2018
Last Update Submitted That Met QC Criteria
May 24, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018ECFerSp
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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