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Not yet recruiting NCT04227249

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

Observational Endometrial Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: no lymph node dissection.
Who it may be relevant to
Registry conditions: Endometrial Cancer. Basic parameters: from 19 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • 3 year recurrence free survival [Time frame: 3 year since surgery]
Secondary outcome measures (10)
  • 5 year recurrence free survival [Time frame: 5 year since surgery]
  • 5 year overall survival [Time frame: 5 year since surgery]
  • surgery time [Time frame: surgery visit]
  • change of Functional Assessment of Cancer Therapy - General (FACT G) score from baseline [Time frame: baseline - 1week - 5week - 3month - 6month]
  • change of Gynecologic Cancer Lymphedema Questionnaire - Korean (GCLQ-K) score from baseline [Time frame: baseline - 5week - 6month - 12month - 18month - 24month - 36month - 48month - 60month]
  • change of Female Sexual Function Index (FSFI) score from baseline [Time frame: baseline - 6month - 12month - 24month - 36month - 48month - 60month]
  • length of stay [Time frame: surgery visit]
  • transfusion [Time frame: surgery visit]
  • hemoglobin decline [Time frame: surgery visit]
  • surgery complication [Time frame: surgery visit]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04227249 · KGOG 3021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗