Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial (iPocc)

• Progression-free survival(PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed until 510 events are observed or until 3 years from the last patient is randomized to the study ] [ Designated as safety issue: No ]
  

• Overall survival (OS) [ Time Frame: weekly during the protocl treatment, then every 3 months for the first 2 years, 6-month for the following 2 years, and once a year thereafter ] [ Designated as safety issue: Yes ]
  
• Tumor response (only patients with evaluable disease) [ Time Frame: every 2 cycles [after 2 cycles, after 4 cycles, after 6 cycles, (after 8 cycles)], the time of discontinuation of the protocol treatment and then at least annually during follow-up ] [ Designated as safety issue: No ]
  
• Adverse events [ Time Frame: weekly during the protocl treatment, then every 3 months for the first 2 years, 6-month for the following 2 years, and once a year thereafter ] [ Designated as safety issue: Yes ]
  
• Treatment completion rate [ Time Frame: After the last cycle of the protocol teatment ] [ Designated as safety issue: No ]
  
• Quality of Life (QOL) assessments [ Time Frame: baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment ] [ Designated as safety issue: No ]
  
• Cost-utility analysis [ Time Frame: baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment ] [ Designated as safety issue: No ]
  

This is a randomized, multicenter international study. Patient are stratified according to Residual tumor diameter([0cm(No residual)] vs. [0cm＜residual＜1cm] vs. [1cm<residual<2cm] vs. [>2 cm]), FIGO stage(StageII vs. III vs. IV) and institution. Patient randomized to one of the treatment arms described below.

RegimenI(Standard treatment: dd-TCiv therapy): Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks

RegimenII(Study treatment: dd-TCip therapy): Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks

The 3-week period (21 days) is 1 cycle. Protocol treatment basically comprises 6 cycles. IDS is allowed to be performed after 3, 4 or 5 cycles of the protocol treatment. In such cases, the protocol treatment must be restarted within 8 weeks after IDS. If IDS is performed, patients can receive up to 3 additional cycles of the protocol treatment after IDS. If interval debulking surgery (IDS) is performed after 3, 4 or 5 cycles, the patients can receive up to 3 additional cycles of the protocol treatment. A total of 6 to 8 cycles will be repeated.

The analysis of efficacy will be performed on all randomized subjects in accordance with the intention-to-treat (ITT) principle. In order to assess the robustness of the results, the same analyses will be done using all randomized subjects who satisfy the eligibility criteria. The analysis of safety will be performed on all subjects who have received at least one dose of study treatment.