LION - Lymphadenectomy in Ovarian Neoplasm (AGO-OVAR OP.3)

• Applicant: Professor Dr. Uwe Wagner
• Subject Area: Hematology, Oncology
• Term: from 2008 to 2018
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 43844406

Pelvic and para-aortic lymphadenectomy (LNE) is well established as part of comprehensive surgical staging in early stage ovarian cancer. The role of LNE in advanced ovarian cancer is unclear. Retrospective analyses indicate a potential benefit of LNE in patients with macroscopically complete intraabdominally resection. However, prospective randomized trials are lacking and a randomized trial in a mixed population composed of both completely debulked patients (30%) and those with small residual tumor intraabdominally (70%) could only show a significant impact of LNE on progression-free survival but not on survival. The lack of sound evidence in this area is reflected by the heterogeneous LNE usage in Germany. In 2004, patients with advanced ovarian cancer who had complete debulking showed a heterogeneous pattern of LNE: 47.9% received pelvic and para-aortic LNE (some of them as sampling only), 27.9% did not receive any LNE and the remaining 24.2% had only limited lymph node evaluation either pelvic or para-aortic. This proposed prospectively randomized controlled multicentre phase 111 trial will clarify the role of LNE in advanced ovarian cancer, thereby either establish LNE as evidence-based part of ovarian cancer surgery in routine care or disregard its use. Both results would provide benefit for the patient by either stopping overtreatment or withheld of optimal surgical care. Endpoints include overall survival but also quality of life and tolerability which allows balancing of supposed objective improvement with subjective outcome results.

• DFG Programme: Clinical Trials