A randomized phase II trial to test the efficacy of intra-peritoneal paclitaxel for gastric cancer with high risk for the peritoneal metastasis (INPACT trial)

Jpn J Clin Oncol. 2011 Feb;41(2):283-6. doi: 10.1093/jjco/hyq187. Epub 2010 Oct 14.

Abstract

Owing to its peculiar pharmacological characteristics, paclitaxel attains substantial intra-peritoneal concentration for a prolonged period when delivered intra-peritoneally, and is active against peritoneal metastasis of ovarian cancer. It is also considered promising against disseminated gastric cancer. However, the fact that the intra-peritoneal paclitaxel has not been approved in Japan has rendered its evaluation by a formal clinical trial impossible. The authors designed a randomized phase II trial using the Kodo Iryo Hyoka system, a new system to legally test an yet unapproved mode of treatment. It is hoped that this trial will result in a breakthrough in the treatment of peritoneal carcinomatosis from gastric cancer.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Agents, Phytogenic / administration & dosage*
  • Feasibility Studies
  • Humans
  • Infusions, Intravenous
  • Infusions, Parenteral
  • Japan
  • Paclitaxel / administration & dosage*
  • Patient Selection
  • Peritoneal Neoplasms / prevention & control*
  • Peritoneal Neoplasms / secondary
  • Research Design
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / pathology

Substances

  • Antineoplastic Agents, Phytogenic
  • Paclitaxel