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Endometrial Cancer, high risk

ECLAT Endometrial Cancer Lymphadenectomy Trial (AGO-OP.6)

Pelvic and Para-aortic Lymphadenectomy in Patients with Stage I or II Endometrial Cancer with High Risk of Recurrence. A Multicenter, Prospective Randomized Controlled Trial

Erkrankung: Gebärmutterkrebs u.a. gynäkologische Tumoren Endometriumkarzinom
Start der Studie am Zentrum: 01.07.2017
Status der Studie: Studie rekrutiert
Ende der Studie: 01.01.2028
Studiendesign: interventionell
Studienart: Operative Studie
Haupteinschlusskritieren: 1. 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
2. absence of bulky lymph nodes
3. Performance status ECOG 0-1
4. age 18 – 75 years
5. written informed consent
6. adequate compliance
7. Study participation after hysterectomy (e.g. for presumed low
risk endometrial cancer) is allowed within 8 weeks after
hysterectomy when stages pT1b and pT2 (all histological
types) and stage pT1a G3 type 1 (endometrioid, endometriod
with squamous differentiation, mucinous) or type 2 tumors (any
percentage of serous, clear cell components) or
carcinosarcoma are found and no LNE performed.
Hauptausschlusskritieren: 8. Stage pT1a, G1 or G2 tumors of type 1 histology
9. sarcomas (except for carcinosarcoma = malignant mixed
Müllerian tumor)
10. EC of FIGO stages III or IV (except for microscopical lymph
node metastases)
11. Evidence of extrauterine disease by visual inspection
12. recurrent EC
13. preceding chemo-, radio, or endocrine therapy for EC
14. Any concomitant disease not allowing surgery including
lymphadenectomy and/or chemotherapy
15. Any medical history indicating excessive peri-operative risk
16. Any current medication containing considerable surgical risk
(e.g. bleeding: due to oral anticoagulating agents)
17. Any known disorder or circumstances making participation in
trial and follow-up questionable. Insufficient compliance is
expected.
18. Patients with second malignancies if disease or treatment
might have an impact on the patient’s prognosis
Prüfarzt: Prof. Dr. Boris Gabriel

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