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

Keiichi Fujiwara, Eriko Aotani, Tetsutaro Hamano, Shoji Nagao, Hiroyuki Yoshikawa, Toru Sugiyama, Junzo Kigawa, Daisuke Aoki, Noriyuki Katsumata, Masahiro Takeuchi, Mitsuaki Suzuki

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24 Citations (Scopus)

Abstract

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 intraperitoneal 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 intraperitoneal administration of carboplatin over intravenous administration. Primary endpoint is progression-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 of intraperitoneal arm and a total of 746 patients will be enrolled in a Phase III study.

Original languageEnglish
Pages (from-to)278-282
Number of pages5
JournalJapanese journal of clinical oncology
Volume41
Issue number2
DOIs
Publication statusPublished - 2011 Feb 1

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Keywords

  • Carboplatin
  • Dose-dense chemotherapy
  • Intraperitoneal chemotherapy
  • Ovarian cancer
  • Paclitaxel

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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