Endometrial Cancer Lymphadenectomy Trial

  • STATUS
    Recruiting
  • End date
    Feb 15, 2029
  • participants needed
    640
  • sponsor
    Philipps University Marburg Medical Center
Updated on 10 June 2021
Investigator
Günter Emons, MD, PhD
Primary Contact
Vivantes Humboldt-Klinikum, Klinik f r Gyn kologie und Geburtsmedizin (5.2 mi away) Contact
+82 other location

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 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.

Details
Condition Cancer of Endometrium Stage I, Cancer of Endometrium Stage II, stage ii endometrial cancer
Treatment Standard surgical procedure for endometrial cancer, systematic lymphadenectomy (LNE)
Clinical Study IdentifierNCT03438474
SponsorPhilipps University Marburg Medical Center
Last Modified on10 June 2021

Eligibility

Yes No Not Sure

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 Mllerian 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)
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