Endometrial Cancer Lymphadenectomy Trial

Study Overview
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Brief Summary
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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.

Official Title
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Pelvic and Para-aortic Lymphadenectomy in Patients With Stage I or II Endometrial Cancer With High Risk of Recurrence

Conditions
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Cancer of Endometrium Stage I, Cancer of Endometrium Stage II

Intervention / Treatment
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* Procedure: Standard surgical procedure for endometrial cancer
* Procedure: systematic lymphadenectomy (LNE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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) absence of bulky lymph nodes performance status ECOG 0-1 age 18 - 75 years written informed consent adequate compliance Exclusion Criteria: stage pT1a, G1 or G2 tumors of type 1 histology sarcomas (except for carcinosarcoma = malignant mixed Müllerian tumor) EC of FIGO stages III or IV (except for microscopical lymph node metastases) evidence of extrauterine disease by visual inspection recurrent EC preceding chemo-, radio, or endocrine therapy for EC any concomitant disease not allowing surgery including lymphadenectomy and/or chemotherapy any medical history indicating excessive peri-operative risk any current medication containing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents) any known disorder or circumstances making participation in trial and follow-up questionable. Insufficient compliance is expected. patients with second malignancies if disease or treatment might have an impact on the patient's prognosis known HIV-infection or AIDS 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A standard surgical procedure<br>Standard surgical procedure for endometrial cancer: total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers) | Procedure: Standard surgical procedure for endometrial cancer<br>* total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)<br>|
| Experimental: Arm B systematic lymphadenectomy (LNE)<br>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<br>* total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)<br>Procedure: systematic lymphadenectomy (LNE)<br>* systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Number of resected lymph nodes | resected pelvic and para-aortic lymph nodes | during surgery |