Comparison Of Survival Between Upfront Primary Debulking Surgery Versus Neoadjuvant Chemotherapy For Stage Iii/Iv Ovarian, Tubal And Peritoneal Cancers In Phase Iii Randomized Trial: Jcog0602.

5500Background: We conducted a phase III non-inferiority trial comparing upfront primary debulking surgery (PDS) and neoadjuvant chemotherapy (NAC) for stage III/IV ovarian, tubal and peritoneal cancers (JCOG0602). Two preceding studies, EORTC55971 and CHORUS demonstrated non-inferior overall survival (OS) of patients treated with NAC. We have already reported reduced invasiveness of NAC setting treatment (NACT) compared to PDS setting treatment (PDST) in analysis of short-term outcomes of JCOG0602. This is a final analysis including primary endpoint of OS. Methods: Target cancer was diagnosed by 1) imaging studies (CT and/or MRI), 2) cytology of ascites, pleural effusions or fluids obtained by tumor centesis, and 3) CA125 u003e 200 U/ml and CEA u003c 20 ng/ml. Patients were randomized to PDS arm (PDS followed by 8 cycles of paclitaxel and carboplatin, i.e. TC regimen) and NAC arm (4 cycles of TC, interval debulking surgery [IDS], 4 cycles of TC). Planned sample size was 300 with 3-year OS of 25% in PDS arm, 30.3...