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  • 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)

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Clinical trial
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)
  1. Günter Emons1,
  2. Jae-Weon Kim2,
  3. Karin Weide3,
  4. Nikolaus de Gregorio4,
  5. Pauline Wimberger5,
  6. Fabian Trillsch6,
  7. Boris Gabriel7,
  8. Dominik Denschlag8,
  9. Stefan Kommoss9,
  10. Mustafa Aydogdu10,
  11. Thomas Papathemelis11,
  12. Martina Gropp-Meier12,
  13. Mustafa-Zelal Muallem13,
  14. Cristin Kühn14,
  15. Andreas Müller15,
  16. Matthias Frank16,
  17. Michael Weigel17,
  18. Holger Bronger18,
  19. Björn Lampe19,
  20. Jörn Rau3,
  21. Carmen Schade-Brittinger20 and
  22. Philipp Harter21
  1. 1 Universitätsmedizin Göttingen, Gottingen, Germany
  2. 2 Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Korea
  3. 3 Koordinierungszentrum für Klinische Studien (KKS), Marburg, Germany
  4. 4 Obstetrics and Gynecology, Universität Ulm, Ulm, Baden-Württemberg, Germany
  5. 5 Department of Gynecology and Obstetrics, Technische Universität Dresden, Dresden, Germany
  6. 6 Obsterics and Gynecology, Ludwig-Maximilians-Universität München Medizinische Fakultät, Munchen, Bayern, Germany
  7. 7 Obstetrics and Gynecology, St Josefs Hospital Wiesbaden GmbH, Wiesbaden, Hessen, Germany
  8. 8 Hochtaunus-Kliniken, Bad Homburg, Germany
  9. 9 Department für Frauenheilkunde, Universitätsklinikum Tübingen, Tubingen, Germany
  10. 10 Klinik für Gynäkologie, Bremen Mitte, Bremen, Germany
  11. 11 Obstetrics and Gynecology, Klinikum St Marien Amberg, Amberg, Bayern, Germany
  12. 12 Oberschwabenklinik gGmbH, Ravensburg, Baden-Württemberg, Germany
  13. 13 Charite Universitatsmedizin Berlin, Berlin, Germany
  14. 14 Obstetrics and Gynecology, Christliches Klinikum Unna Mitte, Unna, Germany
  15. 15 Städtisches Klinikum Karlsruhe gGmbH, Karlsruhe, Baden-Württemberg, Germany
  16. 16 Obstetrics and Gynecology, Ortenau Klinikum Offenburg-Kehl, Offenburg, Baden-Württemberg, Germany
  17. 17 Obstetrics and Gynecology, Leopoldina Krankenhaus Schweinfurt GmbH, Schweinfurt, Germany
  18. 18 Department of Gynecology and Obstetrics, Technical University of Munich, Munchen, Germany
  19. 19 Gynäkologie u Geburtshilfe, Florence-Nightingale-Krankenhaus, Dusseldorf, Germany
  20. 20 Philipps-Universität Marburg Koordinierungszentrum für Klinische Studien, Marburg, Hessen, Germany
  21. 21 Department of Gynecology and Gynecologic Oncology, Evangelische Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung Essen-Huttrop, Essen, Germany
  1. Correspondence to Professor Günter Emons, Universitätsmedizin Göttingen, Gottingen, Germany; emons{at}med.uni-goettingen.de

Abstract

Background The impact of comprehensive pelvic and para-aortic lymphadenectomy on survival in patients with stage I or II endometrial cancer with a high risk of recurrence is not reliably documented. The side effects of this procedure, including lymphedema and lymph cysts, are evident.

Primary Objective Evaluation of the effect of comprehensive pelvic and para-aortic lymphadenectomy in the absence of bulky nodes on 5 year overall survival of patients with endometrial cancer (International Federation of Gynecology and Obstetrics (FIGO) stages I and II) and a high risk of recurrence.

Study Hypothesis Comprehensive pelvic and para-aortic lymphadenectomy will increase 5 year overall survival from 75% (no lymphadenectomy) to 83%, corresponding to a hazard ratio of 0.65.

Trial Design Open label, randomized, controlled trial. In arm A, a total hysterectomy plus bilateral salpingo-oophorectomy is performed. In arm B, in addition, a systematic pelvic and para-aortic lymphadenectomy up to the level of the left renal vein is performed. For all patients, vaginal brachytherapy and adjuvant chemotherapy (carboplatin/paclitaxel) are recommended.

Major Inclusion Criteria Patients with histologically confirmed endometrial cancer stages pT1b–pT2, all histological subtypes, and pT1a endometrioid G3, serous, clear cell, or carcinosarcomas can be included when bulky nodes are absent. When hysterectomy has already been performed (eg, for presumed low risk endometrial cancer), study participation is also possible.

Exclusion Criteria Patients with pT1a, G1 or 2 of type 1 histology or uterine sarcomas (except for carcinosarcomas), endometrial cancers of FIGO stage III or IV (except for microscopic lymph node metastases) or visual extrauterine disease.

Primary Endpoint Overall survival calculated from the date of randomization until death.

Sample Size 640 patients will be enrolled in the study.

Estimated Dates for Completing Accrual and Presenting Results At present, 252 patients have been recruited. Based on this, accrual should be completed in 2025. Results should be presented in 2031.

Trial Registration NCT03438474.

  • endometrial neoplasms
  • SLN and lymphadenectomy

Data availability statement

All data relevant to the study are included in the article.

https://doi.org/10.1136/ijgc-2021-002703

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    Data availability statement

    All data relevant to the study are included in the article.

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    Footnotes

    • Contributors GE, KW, DD, JR, CS-B, and PH developed the protocol and applied for the funding. All authors participated in the recruitment, treatment, and documentation of the patients studied. All authors participated in the preparation of the manuscript.

    • Funding This trial is supported by Deutsche Krebshilfe (German Cancer Aid).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.