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Endometrial Cancer Lymphadenectomy Trial

Study acronym: ECLAT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since May 9, 2023, no change to tracked fieldsv9-v10
  2. Study sites: 59 to 61v8
  3. Study sites: 57 to 59v7
  4. Study sites: 46 to 57v6
  5. Site details revised at 4 of 46 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 2 to 46v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 15, 2018 to Mar 28, 2018
    • Site details revised at 2 of 2 sites
    v3
  3. Start date: Feb 15, 2018 to Mar 15, 2018v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary aim of this trial is to ascertain whether or not systematic pelvic and para-aortic lymphadenectomy (LNE) does have a significant impact on overall survival (OS) in patients with endometrial cancer (EC) FIGO Stages I or II and high risk of recurrence. Secondary aims will be to evaluate the effect of LNE on disease free survival (DFS) and quality of life, as well as the complications and side effects of LNE and the number of resected lymphnodes. 640 patients with histologically confirmed EC with high risk of recurrence (stage pT1b - pT2, all histological subtypes; pT1a, G3 endometrioid or serous or clear cell EC or carcinosarcomas) will be randomized. In Arm A, a total hysterectomy and bilateral salpingo-oophorectomy and in case of serous or clear cell EC additionally an omentectomy will be performed. In arm B in addition a systematic pelvic and para-aortic LNE up to the level of the left renal vein will be performed.
Trial Details
NCT Number NCT03438474
Lead Sponsor Philipps University Marburg
Collaborators: German Cancer Aid
Conditions
(from sponsor)		 Cancer of Endometrium Stage I, Cancer of Endometrium Stage II
Related terms Endometrial Neoplasms
Enrollment 640 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov