Standard surgical procedure for endometrial cancer
Proceduretotal hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)
NCT Number: NCT03438474
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.
Interested in participating?
Request Info18 year–75 year
Female
Interventional
Not applicable
Ostalb-Klinikum Aalen, Frauenklinik, Aalen, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)
systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels
Time frame: 60 months
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on overall survival in EC patients with high risk of recurrence
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
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
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on Disease specific survival
Time frame: during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months
Assessment of perioperative complications and site effects of LNE
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
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
Health related Quality of life (QoL)
Time frame: during surgery
resected pelvic and para-aortic lymph nodes
Contact information is provided by the study sponsor or research team.
Günter Emons, Professor MD
CONTACT
Philipp Harter, Professor MD
CONTACT
Philipps University Marburg
Other
Pelvic and Para-aortic Lymphadenectomy in Patients With Stage I or II Endometrial Cancer With High Risk of Recurrence
Acronym: ECLAT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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