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

Pelvic and Para-aortic Lymphadenectomy in Patients With Stage I or II Endometrial Cancer With High Risk of Recurrence

Not applicable Interventional Philipps University Marburg · NCT03438474

This study is testing if removing lymph nodes during surgery can help people with early-stage high-risk endometrial cancer live longer and have a better quality of life.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment640 (estimated)
Ages18 Years to 75 Years
SexFemale
SponsorPhilipps University Marburg Academic / other
Drugs / interventionschemotherapy
Locations61 sites (Aalen and 60 other locations)
Trial IDNCT03438474 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18-75 with histologically confirmed endometrial cancer at clinical stages T1b or T2 and high risk of recurrence.

Not a fit: Patients with low-risk endometrial cancer or those with advanced-stage disease (FIGO stages III or IV) may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates for patients with high-risk endometrial cancer.

How similar studies have performed: Previous studies have shown varying results regarding the impact of lymphadenectomy on survival in endometrial cancer, making this approach both relevant and necessary for further investigation.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Aalen and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cancer of Endometrium Stage ICancer of Endometrium Stage II
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.