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Poster display session

1149 - J-FORCE study: A randomized, double-blind, placebo-controlled phase III study evaluating olanzapine (5 mg) combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based, highly emetogenic chemotherapy


10 Sep 2017


Poster display session


Hironobu Hashimoto


Annals of Oncology (2017) 28 (suppl_5): v543-v567. 10.1093/annonc/mdx388


H. Hashimoto1, S. Iwasa2, M. Abe3, T. Yanai1, S. Zenda4, T. Yamaguchi5, H. Kaba6, H. Fukuda7, H. Terakado1, Y. Ohe8

Author affiliations

  • 1 Pharmacy, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 2 Department Of Gi Medical Oncology, National Cancer Center Hospital, Tokyo/JP
  • 3 Department Of Gyne Oncology, Shizuoka Cancer center, Shizuoka/JP
  • 4 Department Of Radiation Oncology, National Cancer Center Hospital East, Chiba/JP
  • 5 Biostatistics, Tohoku University Graduate School of Medicine, Sendai/JP
  • 6 Data Management Section, National Cancer Center, Tokyo/JP
  • 7 Data Management Section, National Cancer Center Hospital, Tokyo/JP
  • 8 Department Of Thoracic Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP


Abstract 1149


In the Alliance A221301 study, olanzapine (OLZ; 10 mg) significantly improved the prevention of nausea in patients who were receiving highly emetogenic chemotherapy (HEC). However, growing concerns exist concerning somnolence and sedation. We previously reported on the efficacy and safety of two doses (5 mg and 10 mg) of OLZ in combination with aprepitant (APR), palonosetron (PALO), and dexamethasone (DEX) in patients receiving HEC. OLZ (5 mg) seemed to lead to lower somnolence than OLZ (10 mg) and was equally effective in preventing nausea. The aim of this phase III study is to evaluate the efficacy and safety of 5 mg OLZ doses as compared with placebo, in combination with APR, PALO, and DEX, for the control of nausea in patients receiving HEC.

Trial design

Eligibility criteria for patients include those who are aged 20–75 years, have an Eastern Cooperative Oncology Group (ECOG) performance status between 0–2, and have malignant disease who will be scheduled to receive HEC with cisplatin at a dose ≥ 50 mg/m2. Having diabetes mellitus or being treated with antipsychotic agents within 48 hours before enrollment make patients ineligible for the study. Patients are randomly assigned to receive either a 5 mg OLZ dose or placebo orally after supper on days 1–4, in combination with APR (125 mg p.o. on day 1, 80 mg p.o. on days 2–3), PALO (0.75 mg i.v. on day 1) and DEX (9.9 mg i.v. on day 1 and 6.6 mg i.v. on days 2–4). The primary endpoint is a complete response (CR), defined as no emetic episodes and without the use of rescue medications in the delayed phase (24 to 120 hours). Secondary endpoints include a CR during acute (0 to 24 hours) and overall phases (0 to 120 hours), complete and total control rates, and the level of nausea, appetite and somnolence. A total of 690 patients are required to achieve 80% power for a one-sided significance level of 0.025. We expect the CR rate of the placebo and olanzapine arms to be 65% and 75%, respectively.

Clinical trial identification


Legal entity responsible for the study

Japan Supportive, Palliative and Psycho Social Oncology Group


Japan Agency for Medical Research and Development


All authors have declared no conflicts of interest.

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