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NCT04227249 Clinical Trial

3 Year Recurrence Free Survival in Ultra-low-risk Endometrial Cancer

Endometrial Cancer Clinical Trial

— TREE PRO  

Official title:
Three-year Recurrence Free Survival in Patients With Ultra-low-risk Endometrial Cancer Who do Not Undergo Lymph Node dissEction

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04227249
Other study ID # KGOG 3021
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2020
Est. completion date March 2027

Study information
Verified date January 2020
Source Seoul National University Hospital
Contact kidong kim, md
Phone 82 31 787 7262
Email kidong.kim.md@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 153
Est. completion date March 2027
Est. primary completion date March 2025
Accepts healthy volunteers
Gender Female
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• no lymph node dissection
do not undergo lymph node dissection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 3 year recurrence free survival 3 year recurrence free survival 3 year since surgery
Secondary 5 year recurrence free survival 5 year recurrence free survival 5 year since surgery
Secondary 5 year overall survival 5 year overall survival 5 year since surgery
Secondary surgery time from surgery start to end surgery visit
Secondary change of Functional Assessment of Cancer Therapy - General (FACT G) score from baseline functional assessment of cancer therapy - general baseline - 1week - 5week - 3month - 6month
Secondary change of Gynecologic Cancer Lymphedema Questionnaire - Korean (GCLQ-K) score from baseline gynecologic cancer lymphedema questionnaire - Korean baseline - 5week - 6month - 12month - 18month - 24month - 36month - 48month - 60month
Secondary change of Female Sexual Function Index (FSFI) score from baseline female sexual function index baseline - 6month - 12month - 24month - 36month - 48month - 60month
Secondary length of stay from admission to discharge surgery visit
Secondary transfusion amount of transfusion surgery visit
Secondary hemoglobin decline change of hemoglobin level from baseline to postoperative lowest level surgery visit
Secondary surgery complication any surgery complications observed surgery visit
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