Study protocol for J-SUPPORT 1604 (J-FORCE): A randomized, double blind, placebo-controlled Phase III study evaluating olanzapine (5 mg) plus standard triple antiemetic therapy for prevention of chemotherapy induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy

Hironobu Hashimoto, Masakazu Abe, Takako Yanai, Takuhiro Yamaguchi, Sadamoto Zenda, Yosuke Uchitomi, Haruhiko Fukuda, Mikio Mori, Satoru Iwasa, Noboru Yamamoto, Yuichiro Ohe

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

The Guidelines of the Japan Society of Clinical Oncology recommend standard triple antiemetic therapy with aprepitant, a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone for patients receiving highly emetogenic chemotherapy. Recently, a Phase III study demonstrated the significance of adding of olanzapine (10 mg) to standard triple antiemetic therapy. Olanzapine is associated with somnolence, and we have previously conducted a randomized Phase II study to evaluate the efficacy and safety of 10 mg and 5 mg olanzapine. Lower dose of olanzapine reduced the incidence of somnolence. Therefore, we conducted a randomized, double blind, placebo-controlled, Phase III study to evaluate the efficacy of olanzapine (5 mg) combined with standard triple antiemetic therapy for cisplatin-based highly emetogenic chemotherapy. This study initiated in Feb 2017. A total of 690 patients are planned to be enrolled over a period of 2 years. This study has been registered at the UMIN Clinical Trials Registry as UMIN000024676.

Original languageEnglish
Pages (from-to)950-952
Number of pages3
JournalJapanese journal of clinical oncology
Volume48
Issue number10
DOIs
Publication statusPublished - 2018 Jan 1

Keywords

  • CINV
  • Cisplatin
  • Olanzapine
  • Phase III
  • Placebo

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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