Status:
RECRUITING
Endometrial Cancer Lymphadenectomy Trial
Lead Sponsor:
Philipps University Marburg
Collaborating Sponsors:
German Cancer Aid
Conditions:
Cancer of Endometrium Stage I
Cancer of Endometrium Stage II
Eligibility:
FEMALE
18-75 years
Phase:
NA
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 endometria...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2029
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT03438474
Start Date
March 28 2018
End Date
February 15 2029
Last Update
November 25 2024
Active Locations (61)
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1
Ostalb-Klinikum Aalen, Frauenklinik
Aalen, Germany, 73430
2
Klinikum St. Marien Amberg, Frauenklinik
Amberg, Germany, 92224
3
Klinikum Ansbach, Klinikum Ansbach
Ansbach, Germany, 91522
4
Universitätsklinikum Augsburg, Frauenklinik
Augsburg, Germany, 86156