An interventional study of Standard surgical procedure for endometrial cancer and systematic lymphadenectomy (LNE) in Cancer of Endometrium Stage I and Cancer of Endometrium Stage II, sponsored by Philipps University Marburg. Recruiting at 61 sites in 3 countries. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Philipps University Marburg · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Standard surgical procedure for endometrial cancer: total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)
Procedure: Standard surgical procedure for endometrial cancer
In addition to standard procedures as defined for Arm A: systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels
Procedure: Standard surgical procedure for endometrial cancer · Procedure: systematic lymphadenectomy (LNE)
total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)
systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels
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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Philipps University Marburg