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 |