Endometrial Cancer, Fertility
Conditions
Keywords
Endometrial cancer, Atypical hyperplasia, Fertility-preserving, Remission time, Recurrence, Pregnancy, Progesterone receptor
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.
Interventions
DRUGMetformin
Metformin is given to patients 1-1.5g/d.
Sponsors
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
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate | through study completion, an average of 3 months | Histologically shows absence of pathological hyperplasia or carcinoma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate | through study completion, an average of 3 months | Pregnancy test shows pregnancy after complete response. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate | through study completion, an average of 3 months | Pathology shows atypical hyperplasia or carcinoma again after complete response. |
Countries
China
Contacts
Primary ContactJianliu Wang, Professor
Backup ContactRong Zhou, Professor
Outcome results
None listed