Cancer of Endometrium Stage I Clinical Trial
— ECLATOfficial title:
Pelvic and Para-aortic Lymphadenectomy in Patients With Stage I or II Endometrial Cancer With High Risk of Recurrence
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.
| Status | Recruiting |
| Enrollment | 640 |
| Est. completion date | February 15, 2029 |
| Est. primary completion date | February 15, 2028 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 75 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Ostalb-Klinikum Aalen, Frauenklinik | Aalen | |
| Germany | Klinikum St. Marien Amberg, Frauenklinik | Amberg | |
| Germany | Klinikum Ansbach, Klinikum Ansbach | Ansbach | |
| Germany | Universitätsklinikum Augsburg, Frauenklinik | Augsburg | |
| Germany | Hochtaunus-Kliniken gGmbH, Frauenklinik | Bad Homburg | |
| Germany | Sozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde | Bamberg | |
| Germany | Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe | Berlin | |
| Germany | Martin-Luther-Krankenhaus, Klinik für Gynäkologie und Geburtshilfe | Berlin | |
| Germany | SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik | Berlin | |
| Germany | Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und Geburtsmedizin | Berlin | |
| Germany | Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin | Berlin | |
| Germany | Kliniken Böblingen, Frauenklinik | Böblingen | |
| Germany | Universitätsklinikum Bonn, Zentrum für Geburtshilfe u. Frauenheilkunde | Bonn | |
| Germany | Sana Kliniken Leipziger Land GmbH, Klinik für Gynäkologie und Geburtshilfe | Borna | |
| Germany | Städtisches Klinikum Braunschweig gGmbH, Frauenklinik | Braunschweig | |
| Germany | Klinikum Bremen Mitte gGmbH, Frauenklinik | Bremen | |
| Germany | Donau-Ries Klinik Donauwörth, Klinik für Frauenheilkunde und Geburtshilfe | Donauwörth | |
| Germany | Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik f. Frauenheilkunde u. Geburtshilfe | Dresden | |
| Germany | Kaiserswerther-Diakonie, Florence-Nightingale-Krankenhaus, Gynäkologie u. Geburtshilfe | Düsseldorf | |
| Germany | Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Gynäkologische Onkologie | Essen | |
| Germany | Klinikum der Johann Wolfgang Goethe Universität, Klinik für Gynäkologie und Geburtshilfe | Frankfurt/Main | |
| Germany | Universitätsklinikum Freiburg, Universitätsfrauenklinik | Freiburg | |
| Germany | Klinikum Fulda gAG, Frauenklinik | Fulda | |
| Germany | Klinikum Fürth, Frauenklinik Nathanstift | Fürth | |
| Germany | Universitätsklinikum Gießen und Marburg GmbH, Frauenklinik | Gießen | |
| Germany | Klinikum Göttingen, Georg-August-Universität, Universitätsfrauenklinik | Göttingen | |
| Germany | Klinikum der Ernst-Moritz-Arndt-Universität, Klinik u. Poliklinik f. Gynäkologie u. Geburtshilfe | Greifswald | |
| Germany | Klinikum Gütersloh, Frauenklinik | Gütersloh | |
| Germany | Universitätsklinikum Halle/S., Universitätsklinik und Poliklinik für Gynäkologie | Halle/Saale | |
| Germany | Agaplesion Diakonieklinikum Hamburg, Frauenklinik | Hamburg | |
| Germany | Albertinen Krankenhaus/Albertinen-Haus gemeinnützige GmbH, Station B2 Gynäkologie | Hamburg | |
| Germany | Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie | Hamburg | |
| Germany | Medizinische Hochschule Hannover, Frauenklinik | Hannover | |
| Germany | Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe | Jena | |
| Germany | Städtisches Klinikum Karlsruhe, Frauenklinik | Karlsruhe | |
| Germany | ViDia Christliche Kliniken Karlsruhe, Frauenklinik | Karlsruhe | |
| Germany | Evangelisches Krankenhaus Kalk gGmbH, Gynäkologie und Geburtshilfe | Köln | |
| Germany | Klinikum Mannheim GmbH, Universitäts-Frauenklinik | Mannheim | |
| Germany | Evangelisches Krankenhaus Bethesda, Klinik für Frauenheilkunde und Geburtshilfe | Mönchengladbach | |
| Germany | Klinikum der Universität München (LMU), Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe | München | |
| Germany | Klinikum Dritter Orden, Klinik für Gynäkologie und Geburtshilfe | München | |
| Germany | Klinikum rechts der Isar der Technischen Universität, Frauen- und Poliklinik | München | |
| Germany | Klinikum Offenbach GmbH, Frauenklinik | Offenbach | |
| Germany | Ortenau Klinikum St. Josefsklinik, Gynäkologie | Offenburg | |
| Germany | Klinikum Passau, Frauenklinik | Passau | |
| Germany | Oberschwabenklinik Krankenhaus St. Elisabeth, Frauenklinik | Ravensburg | |
| Germany | Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde u. Geburtshilfe | Regensburg | |
| Germany | Leopoldina Krankenhaus Schweinfurt GmbH, Frauenheilkunde und Geburtshilfe | Schweinfurt | |
| Germany | Städt. Klinikum Solingen gGmbH, Frauenheilkunde u. Geburtshilfe | Solingen | |
| Germany | Klinikum Starnberg, Klinik für Frauenheilkunde und Geburtshilfe | Starnberg | |
| Germany | Klinikum St. Elisabeth Straubing GmbH, Klinik für Frauenheilkunde und Geburtshilfe | Straubing | |
| Germany | Kreiskliniken Traunstein-Trostberg GmbH, Frauenklinik | Traunstein | |
| Germany | Universitätsklinikum Tübingen, Universitätsfrauenklinik | Tübingen | |
| Germany | Universitätsklinikum Ulm, Universitätsfrauenklinik | Ulm | |
| Germany | Christliches Klinikum Unna Mitte, Klinik für Gynäkologie und Geburtshilfe | Unna | |
| Germany | Schwarzwald-Baar Klinikum, Frauenklinik | Villingen-Schwenningen | |
| Germany | St. Josefs-Hospital, Frauenklinik | Wiesbaden | |
| Germany | Klinikum der Stadt Wolfsburg, Frauenklinik | Wolfsburg | |
| Japan | Okayama University Hospital | Okayama | |
| Japan | Saitama Medical University International Medical Center | Saitama | |
| Korea, Republic of | Seoul National University Hospital, Department of Obstetrics & Gynecology | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Philipps University Marburg Medical Center | German Cancer Aid |
Germany, Japan, Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival (OS) | Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on overall survival in EC patients with high risk of recurrence | 60 months | |
| Secondary | Disease free survival (DFS) | Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease free survival | 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 | |
| Secondary | Disease specific survival (DSS) | Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease specific survival | 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 | |
| Secondary | Assessment of serious complications | Assessment of perioperative complications and site effects of LNE | during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months | |
| Secondary | EORTC QLQ-C30 | Health related Quality of life (QoL) | 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 | |
| Secondary | EORTC QLQ-EN24 | Health related Quality of life (QoL) | 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 | |
| Secondary | Number of resected lymph nodes | resected pelvic and para-aortic lymph nodes | during surgery |