Impact of lymph node removal on survival in early-stage endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates whether systematic pelvic and para-aortic lymphadenectomy (LNE) improves overall survival in patients with high-risk endometrial cancer at FIGO Stages I or II. A total of 640 patients with histologically confirmed endometrial cancer will be randomized into two groups: one receiving standard surgical procedures and the other undergoing additional lymphadenectomy. The study will also assess disease-free survival, quality of life, and the complications associated with LNE. The aim is to determine the effectiveness of LNE in enhancing patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. histologically confirmed EC of clinical stages T1b and T2 (all histological types) and stage T1a G3 type 1 (endometrioid, endometriod with squamous differentiation, mucinous) or type 2 tumors (any percentage of serous or clear cell component) or carcinosarcoma
2. a) no previous surgery concerning EC (primary surgery) or b) surgery after hysterectomy (e.g. for presumed low risk endometrial cancer) is allowed within 8 weeks after hysterectomy if no LNE was performed (secondary surgery)
3. absence of bulky lymph nodes
4. performance status ECOG 0-1
5. age 18 - 75 years
6. written informed consent
7. adequate compliance

Exclusion Criteria:

1. stage pT1a, G1 or G2 tumors of type 1 histology
2. sarcomas (except for carcinosarcoma = malignant mixed Müllerian tumor)
3. EC of FIGO stages III or IV (except for microscopical lymph node metastases)
4. evidence of extrauterine disease by visual inspection
5. recurrent EC
6. preceding chemo-, radio, or endocrine therapy for EC
7. any concomitant disease not allowing surgery including lymphadenectomy and/or chemotherapy
8. any medical history indicating excessive peri-operative risk
9. any current medication containing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents)
10. any known disorder or circumstances making participation in trial and follow-up questionable. Insufficient compliance is expected.
11. patients with second malignancies if disease or treatment might have an impact on the patient's prognosis
12. known HIV-infection or AIDS
13. simultaneous participation in other clinical trials if not permitted by the steering committee (translational or QoL studies not interfering with the objectives of ECLAT are allowed)

Where it's running

• Ostalb-Klinikum Aalen, Frauenklinik
  Aalen, Germany Recruiting
• Klinikum St. Marien Amberg, Frauenklinik
  Amberg, Germany Recruiting
• Klinikum Ansbach, Klinikum Ansbach
  Ansbach, Germany Recruiting
• Universitätsklinikum Augsburg, Frauenklinik
  Augsburg, Germany Recruiting
• Hochtaunus-Kliniken gGmbH, Frauenklinik
  Bad Homburg, Germany Recruiting
• Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde
  Bamberg, Germany Recruiting

+11 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Philipp Harter, Professor MD — Kliniken Essen Mitte, Gynäkologie und gynäkologische Onkologie
• Study coordinator: Philipp Harter, Professor MD
• Email: p.harter@kem-med.com
• Phone: +49 (0) 201 174-34511

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.