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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
640
total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)
systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels
Ostalb-Klinikum Aalen, Frauenklinik
Aalen, Germany
RECRUITINGKlinikum St. Marien Amberg, Frauenklinik
Amberg, Germany
RECRUITINGKlinikum Ansbach, Klinikum Ansbach
Ansbach, Germany
RECRUITINGUniversitätsklinikum Augsburg, Frauenklinik
Augsburg, Germany
Overall survival (OS)
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on overall survival in EC patients with high risk of recurrence
Time frame: 60 months
Disease free survival (DFS)
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease free survival
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
Disease specific survival (DSS)
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease specific survival
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
Assessment of serious complications
Assessment of perioperative complications and site effects of LNE
Time frame: during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months
EORTC QLQ-C30
Health related Quality of life (QoL)
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
EORTC QLQ-EN24
Health related Quality of life (QoL)
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
Number of resected lymph nodes
resected pelvic and para-aortic lymph nodes
Time frame: during surgery
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Hochtaunus-Kliniken gGmbH, Frauenklinik
Bad Homburg, Germany
RECRUITINGSozialstiftung Bamberg, Klinikum am Bruderwald, Klinik für Frauenheilkunde
Bamberg, Germany
RECRUITINGSANA Klinikum Lichtenberg, Oskar-Ziehten-Krankenhaus, Frauenklinik
Berlin, Germany
RECRUITINGVivantes Auguste-Viktoria-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
Berlin, Germany
RECRUITINGCharité Campus Virchow-Klinikum, Klinik für Frauenheilkunde und Geburtshilfe
Berlin, Germany
RECRUITINGVivantes Humboldt-Klinikum, Klinik für Gynäkologie und Geburtsmedizin
Berlin, Germany
RECRUITING...and 51 more locations