NCT03438474: ECLAT

Endometrial Cancer Lymphadenectomy Trial

Recruiting now NA Last updated 25 November 2024

What this trial tests

NA trial testing Standard surgical procedure for endometrial cancer in Cancer of Endometrium Stage I in 640 participants. Currently enrolling.

Timeline

28 March 2018

Primary endpoint
15 February 2028

15 February 2029

Quick facts

Lead sponsor	Philipps University Marburg
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	640
Start date	28 March 2018
Primary completion	15 February 2028
Estimated completion	15 February 2029
Sites	61 locations across Japan, Germany, South Korea

Drugs / interventions tested

• Standard surgical procedure for endometrial cancer
• systematic lymphadenectomy (LNE)

Conditions studied

• Cancer of Endometrium Stage I — all drugs for Cancer of Endometrium Stage I →
• Cancer of Endometrium Stage II — all drugs for Cancer of Endometrium Stage II →

Sponsor

Philipps University Marburg

Who can join

Adults 18 to 75, female only, with Cancer of Endometrium Stage I or Cancer of Endometrium Stage II. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Risk Stratification of Endometrial Cancer Patients: FIGO Stage, Biomarkers and Molecular Classification.
   Kasius JC, Pijnenborg JMA, Lindemann K, Forsse D, et al · · 2021 · cited 67× · PMID 34831000 · DOI 10.3390/cancers13225848
2. Endometrial Cancer Lymphadenectomy Trial (ECLAT) (pelvic and para-aortic lymphadenectomy in patients with stage I or II endometrial cancer with high risk of recurrence; AGO-OP.6).
   Emons G, Kim JW, Weide K, de Gregorio N, et al · · 2021 · cited 24× · PMID 34226291 · DOI 10.1136/ijgc-2021-002703
3. Low-Volume Metastases in Apparent Early-Stage Endometrial Cancer: Prevalence, Clinical Significance, and Future Perspectives.
   Fumagalli D, De Vitis LA, Caruso G, Occhiali T, et al · · 2024 · cited 7× · PMID 38611016 · DOI 10.3390/cancers16071338
4. From the Beginning of the Korean Gynecologic Oncology Group to the Present and Next Steps.
   Min KJ, Kim NK, Song JY, Choi MC, et al · · 2024 · cited 2× · PMID 39410040 · DOI 10.3390/cancers16193422
5. SEOM-GEICO clinical guidelines on endometrial cancer (2025).
   Ramírez SP, Fidalgo AP, Ginesta MPB, De Juan Ferré A, et al · · 2025 · cited 1× · PMID 40986254 · DOI 10.1007/s12094-025-04046-1
6. Comprehensive pelvic and paraaortic lymphadenectomy in patients with apparently early stage uterine serous carcinoma - an anachronism?
   Emons G. · · 2020 · cited 1× · PMID 32808502 · DOI 10.3802/jgo.2020.31.e76
7. Comparison of tracer application methods for sentinel lymph node detection in open surgery patients with endometrial cancer: a retrospective cohort study.
   Sehnal B, Waldauf P, Matej R, Hruda M, et al · · 2025 · PMID 40200256 · DOI 10.1186/s12885-025-14037-8