Endometrial Neoplasms
Conditions
Brief summary
This randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA endometrial carcinoma.
Interventions
PROCEDURETH
Total hysterectomy
PROCEDURETH/BSO
Total hysterectomy and bilateral salpingo-oophorectomy
PROCEDUREBPLND
bilateral pelvic and para-aortic lymph node dissection
Sponsors
Shandong University
Huazhong University of Science and Technology
Zhejiang University
Ding Ma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* FIGO stage: ⅠA, endometrial carcinoma; * Female, Chinese women; * premenopausal women； * ≤ 50 years old; * Pathological diagnosis by curettage/hysteroscopy : G1 * No prior treatment; * Provide written informed consent.
Exclusion criteria
* The suspicious metastasis of ovarian; * Family history of ovarian cancer; * Suffering from other malignancies; * Concurrently participating in other clinical trials; * Unable or unwilling to sign informed consents; * Unable or unwilling to abide by protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS) | 3-year DFS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical gynecologic endocrine function | 1-year period | To observe the level of female hormone，i.e., estrogen, FSH, LH |
| Quality of Life | 3-year period | — |
| Overall Survival (OS) | 3-year OS | — |
Countries
China
Outcome results
None listed