LION: Lymphadenectomy in Ovarian Neoplasms

This is an international cooperation - Germany, Belgium, Italy, Czech Republic and Austria - under the direction of the AGO OVAR Study Group. Ovarian cancer is the leading cause of death from gynecological malignancies and is in most cases diagnosed at an advanced stage. Despite optimal therapy consisting of surgery followed by platinumaxanes-based chemotherapy more than half of the patients will die within 5 years after first diagnosis. But there is an uncertainty about the performance of systematic pelvic and paraaortic lymphadenectomy (LNE) in patients with advanced ovarian cancer FIGO IIB - IV after complete debulking. There are hints that this additional procedure has an impact on survival. Therefore, this trial wants to evaluate the hypothesis that systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete resection has a significant impact on overall survival and progression-free survival. In the case of a positive trial lymphadenectomy could become standard treatment in this patient population. In the case of a negative trial, unnecessary surgical procedures can be avoided. Furthermore, this first prospective trial assessing quality of life and long-term morbidity after surgery for ovarian cancer could help to better inform our patients about this treatment. Apart from the potential advantage in survival, the resection of lymph nodes could possibly avoid isolated lymph node recurrences at a later date. Relaparotomy with lymphadenectomy and subsequent chemotherapy are often performed in these patients. If this procedure could help to reduce isolated lymph node recurrences and other relapses an additional economic advantage is possible through less relaparotomies and less chemotherapies for relapse. The main inclusion criteria are primary diagnosis of invasive epithelial ovarian cancer FIGO stage IIB-IV (IV only if resectable metastasis in pleura, liver, spleen, and/or abdominal wall) and macroscopic complete resection. The primary study objective is to assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete debulking with respect to overall survival. Secondary objectives are the safety of systematic pelvic and para-aortic lymphadenectomy in these patients and the effect of systematic LNE on progression-free survival (PFS) and quality of life (QoL). A further objective is to explore the association of number of resected lymph nodes and primary and secondary outcome measures.

This is an international cooperation - Germany, Belgium, Italy, Czech Republic, Korea and Austria under the direction of the AGO OVAR Study Group. Ovarian cancer is the leading cause of death from gynecological malignancies and is in most cases diagnosed at an advanced stage. Despite optimal therapy consisting of surgery followed by platinum/taxanes-based chemotherapy more than half of the patients will die within 5 years after first diagnosis. But there is an uncertainty about the performance of systematic pelvic and paraaortic lymphadenectomy (LNE) in patients with advanced ovarian cancer FIGO IIB IV after complete debulking. There are hints that this additional procedure has an impact on survival. Therefore, this trial wants to evaluate the hypothesis that systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete resection has a significant impact on overall survival and progression-free survival. In the case of a positive trial lymphadenectomy could become standard treatment in this patient population. In the case of a negative trial, unnecessary surgical procedures can be avoided. Furthermore, this first prospective trial assessing quality of life and long-term morbidity after surgery for ovarian cancer could help to better inform our patients about this treatment. Apart from the potential advantage in survival, the resection of lymph nodes could possibly avoid isolated lymph node recurrences at a later date. Relaparotomy with lymphadenectomy and subsequent chemotherapy are often performed in these patients. If this procedure could help to reduce isolated lymph node recurrences and other relapses an additional economic advantage is possible through less relaparotomies and less chemotherapies for relapse. The main inclusion criteria are primary diagnosis of invasive epithelial ovarian cancer FIGO stage IIB-IV (IV only if resectable metastasis in pleura, liver, spleen, and/or abdominal wall) and macroscopic complete resection. The primary study objective is to assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete debulking with respect to overall survival.