NCT03538704

Brief Summary

The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 29, 2018

Status Verified

May 1, 2018

Enrollment Period

5.2 years

First QC Date

March 14, 2018

Last Update Submit

May 24, 2018

Conditions

Endometrial CancerFertility

Keywords

Endometrial cancerAtypical hyperplasiaFertility-preservingRemission timeRecurrencePregnancyProgesterone receptor

Outcome Measures

Primary Outcomes (1)

  • Complete response rate

    Histologically shows absence of pathological hyperplasia or carcinoma.

    through study completion, an average of 3 months

Secondary Outcomes (1)

  • Pregnancy rate

    through study completion, an average of 3 months

Other Outcomes (1)

  • Recurrence rate

    through study completion, an average of 3 months

Study Arms (2)

BMI≥25 group with metformin

EXPERIMENTAL

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,

Drug: Metformin

BMI≥25 group without metformin

NO INTERVENTION

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.

Interventions

MetforminDRUG

Metformin is given to patients 1-1.5g/d.

BMI≥25 group with metformin

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23021687RESULT

MeSH Terms

Conditions

Endometrial NeoplasmsRecurrence

Interventions

Metformin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Jianliu Wang, Professor

    Department of Obstetrics and Gynecology, Peking University People's Hospital

    STUDY CHAIR

Central Study Contacts

Jianliu Wang, Professor

CONTACT

010-88324381wangjianliu1203@163.com

Rong Zhou, Professor

CONTACT

010-88324350zhourong@pku.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2018

First Posted

May 29, 2018

Study Start

January 1, 2015

Primary Completion

March 31, 2020

Study Completion

December 31, 2020

Last Updated

May 29, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)