Phase III trial of upfront debulking surgery versus neoadjuvant chemotherapy for stage III/IV ovarian, tubal and peritoneal cancers: Japan Clinical Oncology Group Study JCOG0602.

On the basis of promising results of neoadjuvant chemotherapy (NAC) in our previous study (JCOG0206), we have been performing a Phase III study of treatment starting with NAC versus standard treatment starting with primary debulking surgery (PDS) for Stage III/IV müllerian carcinomas (ovarian, tubal and peritoneal carcinomas) since November 2006. The purposes are to prove the non-inferiority of the efficacy and to show the decrease in adverse effects resulting from reduced surgical invasiveness of treatment starting with NAC. Three hundred patients with advanced müllerian carcinomas will be randomized during 3 years. NAC arm patients undergo four cycles of NAC with paclitaxel plus carboplatin followed by interval debulking surgery and an additional four cycles of postsurgical chemotherapy. Standard arm patients undergo PDS and eight cycles of postsurgical chemotherapy with or without interval debulking surgery. The primary endpoint is overall survival. The major secondary endpoints are the incidence of adverse events and parameters representing surgical invasiveness.