J-SUPPORT1604

A randomized, double-blind, placebo-controlled phase III trial evaluating olanzapine 5mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy: J-SUPPORT 1604

 

schema_1604_EN

 

Study Title A randomized, double-blind, placebo-controlled phase III trial evaluating olanzapine 5mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy: J-SUPPORT 1604
Principal Investigator/Study Manager/Mentor Masakazu Abe, Hironobu Hashimoto/ Hironobu Hashimoto /Sadamoto Zenda
Condition Malignant solid tumor
UMIN Clinical Trials Registry UMIN000024676
Funding Source Japan Agency for Medical Research and Development
Protocol Paper 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.

Jpn J Clin Oncol. 2018 Oct 1;48(10):950-952.

https://www.ncbi.nlm.nih.gov/pubmed/30124989

Publication

 Olanzapine 5 mg in combination with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy (J-FORCE): a randomised, double-blind, placebo-controlled, phase 3 trial.

THE LANCET Oncology. VOLUME 21, ISSUE 2, P242-249, FEBRUARY 01, 2020

https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30678-3/fulltext

 

[Secondary Analysis]

Efficacy of Olanzapine in Addition to Standard Triplet Antiemetic Therapy for Cisplatin-Based Chemotherapy: A Secondary Analysis of the J-FORCE Randomized Clinical Trial

JAMA Netw Open. 2023 May 1;6(5):e2310894.
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2804394
Spreading effect AMERICAN SOCIETY OF CLINICAL ONCOLOGY（ASCO）Antiemetics Guideline Update. ↓↓

https://ascopubs.org/doi/pdf/10.1200/JCO.20.01296
Press release https://www.ncc.go.jp/en/information/press_release/20191211/index.html