Endometrial CancerECFerSpNCT03538704
Effect of Fertility-sparing Therapy of Early Endometrial Cancer
A study testing Metformin in people with Endometrial Cancer and Fertility, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometrial Cancer, Fertility
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Jianliu Wang, Professor, 010-88324381, wangjianliu1203@163.com
About this study
The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer.
Read the 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.
- Conditions
- Endometrial Cancer, Fertility
- Being tested
- Metformin
- Keywords
- Endometrial cancer, Atypical hyperplasia, Fertility-preserving, Remission time, Recurrence, Pregnancy, Progesterone receptor
- Medical subject headings
- Endometrial Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin is given to patients 1-1.5g/d.
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Histologically shows absence of pathological hyperplasia or carcinoma.
Measured: through study completion, an average of 3 months
Secondary outcomes (1)
Pregnancy rate
Pregnancy test shows pregnancy after complete response.
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Jan 2015
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Jianliu Wang, Professor, Study chair, Department of Obstetrics and Gynecology, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538704
- Sponsor's protocol ID
- 2018ECFerSp
- Acronym
- ECFerSp
- Status last verified
- May 2018
- First submitted
- 14 Mar 2018
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23021687
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fertility-sparing Therapy of Early Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03538704
- Acronym / sponsor ID
- ECFerSp / 2018ECFerSp
- Conditions
- Endometrial Cancer, Fertility
- Keywords
- Endometrial cancer, Atypical hyperplasia, Fertility-preserving, Remission time, Recurrence, Pregnancy, Progesterone receptor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- 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
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI≥25 group with metformin | Experimental | Drug: MetforminPatients 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, |
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin is given to patients 1-1.5g/d. | Drug | BMI≥25 group with metformin |
Primary outcome
Complete response rate
Time frame: through study completion, an average of 3 months
Histologically shows absence of pathological hyperplasia or carcinoma.
1 secondary outcome
Pregnancy rate
Time frame: through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Results publication: PubMed 23021687Gallos 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.
- Individual participant dataSharing planned: No
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianliu Wang, Professor study chair
Department of Obstetrics and Gynecology, Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Endometrial Cancer and Fertility, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianliu Wang, Professor (010-88324381, wangjianliu1203@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03538704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2018.