Endometrial Cancer Lymphadenectomy Trial

Not Applicable

Recruiting

• Conditions: Cancer of Endometrium Stage I; Cancer of Endometrium Stage II

• Registration Number: NCT03438474
• Lead Sponsor: Philipps University Marburg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-19
• Study Start: 2018-03-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25
• Primary Completion: 2028-02-15
• Study Completion: 2029-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 640

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	60 months	Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on overall survival in EC patients with high risk of recurrence

Secondary Outcome Measures

Name	Time	Method
Assessment of serious complications	during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months	Assessment of perioperative complications and site effects of LNE
Disease free survival (DFS)	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
Number of resected lymph nodes	during surgery	resected pelvic and para-aortic lymph nodes
Disease specific survival (DSS)	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
EORTC QLQ-C30	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)
EORTC QLQ-EN24	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)

Trial Locations

Locations (61)

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

SANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik; 🇩🇪 Berlin, Germany

Vivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und Geburtsmedizin; 🇩🇪 Berlin, Germany

Charité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe; 🇩🇪 Berlin, Germany

Vivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin; 🇩🇪 Berlin, Germany

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