Clinical trial NCT03538704: Effect of Fertility-sparing Therapy of Early Endometrial Cancer
Official title: Effect of Fertility-sparing Therapy of Early Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrial Cancer
Fertility
Keywords: Endometrial cancer
Atypical hyperplasia
Fertility-preserving
Remission time
Recurrence
Pregnancy
Progesterone receptor
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Peking University Third Hospital
name: Tianjin Medical University General Hospital
name: Maternal and Child Health Hospital of Hubei Province
name: First Affiliated Hospital, Sun Yat-Sen University
name: Qilu Hospital of Shandong University
First posted: 2018-05-29
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete response rate
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: Pregnancy rate
timeFrame: through study completion, an average of 3 months
Other outcomes:
measure: Recurrence rate
timeFrame: through study completion, an average of 3 months
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Department of Obstetrics and Gynecology, Peking University People's Hospital
name: Jianliu Wang, Professor
role: STUDY_CHAIR
References:
citation: 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.