Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03438474

Endometrial Cancer Lymphadenectomy Trial

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ostalb-Klinikum Aalen, Frauenklinik, Aalen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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)
  • absence of bulky lymph nodes
  • performance status ECOG 0-1
  • age 18 - 75 years
  • written informed consent
  • adequate compliance

Exclusion criteria

  • stage pT1a, G1 or G2 tumors of type 1 histology
  • sarcomas (except for carcinosarcoma = malignant mixed Müllerian tumor)
  • EC of FIGO stages III or IV (except for microscopical lymph node metastases)
  • evidence of extrauterine disease by visual inspection
  • recurrent EC
  • preceding chemo-, radio, or endocrine therapy for EC
  • any concomitant disease not allowing surgery including lymphadenectomy and/or chemotherapy
  • any medical history indicating excessive peri-operative risk
  • any current medication containing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents)
  • any known disorder or circumstances making participation in trial and follow-up questionable. Insufficient compliance is expected.
  • patients with second malignancies if disease or treatment might have an impact on the patient's prognosis
  • known HIV-infection or AIDS
  • 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)

Treatment and study plan

Standard surgical procedure for endometrial cancer

Procedure

total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)

systematic lymphadenectomy (LNE)

Procedure

systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels

Primary outcomes

  1. Overall survival (OS)

    Time frame: 60 months

    Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on overall survival in EC patients with high risk of recurrence

Secondary outcomes

  1. Disease free survival (DFS)

    Time frame: 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months

    Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease free survival

  2. Disease specific survival (DSS)

    Time frame: 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months

    Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease specific survival

  3. Assessment of serious complications

    Time frame: during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months

    Assessment of perioperative complications and site effects of LNE

  4. EORTC QLQ-C30

    Time frame: Baseline, at hospital discharge, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months

    Health related Quality of life (QoL)

  5. EORTC QLQ-EN24

    Time frame: Baseline, at hospital discharge, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months

    Health related Quality of life (QoL)

  6. Number of resected lymph nodes

    Time frame: during surgery

    resected pelvic and para-aortic lymph nodes

Study contacts

Contact information is provided by the study sponsor or research team.

Günter Emons, Professor MD

CONTACT

[email protected]

+49 (0) 551-39 66501

Philipp Harter, Professor MD

CONTACT

[email protected]

+49 (0) 201 174-34511

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • German Cancer Aid

Registry information

Official study title

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

Acronym: ECLAT

Important dates

Study start
2018
Primary completion
2028
Study completion
2029
First posted
Feb 19, 2018
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.