AGO-OP.6 / ECLAT Pelvic and Para-aortic Lymphadenectomy in Patients - - PowerPoint PPT Presentation
AGO-OP.6 / ECLAT Pelvic and Para-aortic Lymphadenectomy in Patients with Stage I or II Endometrial Cancer with High Risk of Recurrence Endometrial Cancer Lymphadenectomy Trial ( ECLAT ) A Multicenter, Prospective Randomized Controlled Trial
Coordinating Investigators
PD Dr. med. Philipp Harter
endometrial cancer
n=640
Type I: endometrioid, endometrioid + squamous differentiation, mucinous Type II: serous, clear cell, carcinosarcoma
SLN in LNE arm as additional procedure allowed
Control of disease status and complications from surgery: by clinical examination, transvaginal sonography, sonography of kidneys, evaluation of QoL, evaluation of presence of lymphedema Visits every 3 months (years 1 – 3), then every 6 months (years 4 and 5) Final visit: 5 years after primary or secondary surgery Recommended adjuvant therapy: Vaginal brachytherapy + 6 courses of carboplatinum/paclitaxel (AUC 5/175mg/m2/every 3 weeks) In case of superiority in ongoing clinical trials (e.g. PORTEC-3; GOG 0258): change of recommendation to external beam radiotherapy with simultaneous cisplatinum followed by 4 cycles of carboplatinum/paclitaxel Arm A n = 320 no lymphadenectomy Arm B n = 320 lymphadenectomy
edema, lymph cysts
Subproject FRAILTY
could be a conceptual method of quantifying a patient’s fitness for surgery which might have a prognostic potential for surgical outcomes in patients who are undergoing oncological surgery Subproject SLN
the number of identified SLN including the region compared to the results of the subsequent full LNE.