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 Prof. Dr. med. Günter Emons PD Dr. med. Philipp Harter

ECLAT-Endometrial Cancer Lymphadenectomy Trial AGO-OP.6 System. lymphadenectomy • histologically confirmed  pelvic endometrial cancer  para-aortic • FIGO IB, II (all subtypes) • FIGO IA, G3 (type I) R • FIGO IA (Type II) • Absence of bulky nodes n=640 • Age 18-80y no lymphadenectomy Primary endpoint: Overall Survival Type I: endometrioid, endometrioid + squamous differentiation, mucinous Type II: serous, clear cell, carcinosarcoma SLN in LNE arm as additional procedure allowed

ECLAT-Endometrial Cancer Lymphadenectomy Trial AGO-OP.6 Arm A Arm B n = 320 n = 320 no lymphadenectomy lymphadenectomy Recommended adjuvant therapy: Vaginal brachytherapy + 6 courses of carboplatinum/paclitaxel (AUC 5/175mg/m 2 /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 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

ECLAT-Endometrial Cancer Lymphadenectomy Trial AGO-OP.6 • Primary endpoint: Overall Survival (5 year OS 75  83%) • Secondary endpoints • Disease free survival (DFS) • Disease specific survival (DSS) • Assessment of perioperative complications and site effects of LNE, lymph edema, lymph cysts • Health related Quality of life (EORTC QLQ-C30, EORTC QLQ-EN24) • Number of resected lymph nodes • Two ancillary projects • Subproject FRAILTY • Subproject SLN

ECLAT-Endometrial Cancer Lymphadenectomy Trial AGO-OP.6 Subproject FRAILTY • The aim of the Subproject FRAILTY is to investigate if the exploration of 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 aim of the Subproject SLN is to investigate the technique of identification, the number of identified SLN including the region compared to the results of the subsequent full LNE.

ECLAT-Endometrial Cancer Lymphadenectomy Trial AGO-OP.6 Interested Groups GINECO NSGO … Participating centers have to qualify! • Comparable to LION: 12 anonymous surgical and pathological reports of a systematic pelvic and para-aortic LNE at a high quality level within 12 months • Active sites in LION without major changes in the surgical team: modified qualification process

ECLAT-Endometrial Cancer Lymphadenectomy Trial AGO-OP.6 • Randomized Phase III trial, prospective, multicenter • Coordinating investigator: Günter Emons • Sponsor: Philipps-University Marburg / AGO Study Group • Planned number of patients: 640 pts. in 5 years • Current accrual: not started yet • Application to German Ethics Committee: July 2017 • So far, 40 German sites have qualified for participation.