3 Year Recurrence Free Survival in Ultra-low-risk Endometrial Cancer
Not yet recruiting
- Conditions
- Endometrial Cancer
- Interventions
- Procedure: no lymph node dissection
- Registration Number
- NCT04227249
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
To verify the safety of omission of lymph node dissection in ultra-low-risk endometrial cancer (KGOG criteria), we examine the survival of women with ultra-low-risk endometrial cancer who do not undergo lymph node dissection
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 153
Inclusion Criteria
- endometrioid type
- anticipated surgery omitting lymph node dissection for endometrial cancer
- pelvis MRI, CA125 - satisfying KGOG criteria
- no distant metastasis
- age 19 or more
Exclusion Criteria
- other cancer within 5 yr
- previous hysterectomy
- previous therapy for endometrial cancer
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Experimental no lymph node dissection women who do not undergo lymph node dissection
- Primary Outcome Measures
Name Time Method 3 year recurrence free survival 3 year since surgery 3 year recurrence free survival
- Secondary Outcome Measures
Name Time Method 5 year recurrence free survival 5 year since surgery 5 year recurrence free survival
hemoglobin decline surgery visit change of hemoglobin level from baseline to postoperative lowest level
surgery complication surgery visit any surgery complications observed
5 year overall survival 5 year since surgery 5 year overall survival
change of Gynecologic Cancer Lymphedema Questionnaire - Korean (GCLQ-K) score from baseline baseline - 5week - 6month - 12month - 18month - 24month - 36month - 48month - 60month gynecologic cancer lymphedema questionnaire - Korean
change of Female Sexual Function Index (FSFI) score from baseline baseline - 6month - 12month - 24month - 36month - 48month - 60month female sexual function index
transfusion surgery visit amount of transfusion
change of Functional Assessment of Cancer Therapy - General (FACT G) score from baseline baseline - 1week - 5week - 3month - 6month functional assessment of cancer therapy - general
length of stay surgery visit from admission to discharge
surgery time surgery visit from surgery start to end