A randomized Phase II/III trial of 3 weekly intraperitoneal versus intravenous carboplatin in combination with intravenous weekly dose-dense paclitaxel for newly diagnosed ovarian, fallopian tube and primary peritoneal cancer

Retrospective studies and a Phase II trial demonstrated the promising efficacy and safety of intraperitoneal administration of carboplatin in ovarian, fallopian tube and primary peritoneal cancer. A Japanese Gynecologic Oncology Group 3016 randomized Phase III trial for these cancers showed dose-dense weekly administration of paclitaxel significant improvement of progression-free survival and overall survival over every 3-week administration. From June 2010, we have been conducting a randomized Phase II/III trial of intravenous versus intraperi-toneal administration of carboplatin every 3 week in combination with dose-dense weekly administration of paclitaxel. The purpose of this trial is to prove the superiority of intraperito-neal administration of carboplatin over intravenous administration. Primary endpoint is pro-gression-free survival and secondary endpoints include overall survival, quality of life assessment and cost–benefit. The first 120 patients will be evaluated for the feasibility o