Efficacy and safety of oral granisetron and dexamethasone for crizotinib-induced nausea and vomiting in patient with non-small cell lung cancer

JRCT ID: jRCTs031180378

Registered date:19/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: non small cell lung cancer
• Date of first enrollment: 01/09/2015
• Target sample size: 30
• Study type: Interventional
• Intervention(s): oral granisetron and dexamethasone for crizotinib-induced nausea and vomiting

Outcome(s)

• Primary Outcome: Complete response rate of control vomiting within 120 hours (day1-5) from the start of administration of Crizotinib

Secondary Outcome

Complete response rate of control vomiting (day6-14)
Complete control rate of vomiting (day1-5 and day6-14)
Total control rate of nausea and vomiting (day1-5 and day6-14)
Time to treatment failure which ever come earlier first vomiting or rescue usage of antiemetic drugs

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. histologically or cytologically confirmed NSCLC
2. diagnosed with ALK or ROS1 fusion gene
3. planned to treat with Crizotinib within 2 weeks
4. 20years old or older
5. possible to oral intake
6. ECOG PS 0-2
7. adequate organ function
8. Written informed consent

Exclude criteria

1. medical history of severe allergy
2. symptomatic brain metastasis
3. medical history of seizure and who need epilepsy drug
4. gastrointestinal obstruction
5. pregnant, breast-feeding, and childbearing potential
6. diagnosed with interstitial lung disease or pulmonary fibrosis by chest CT
7. difficult to registration due to mental illness
8. systemic steroid administration (oral or intravenous)
9. started to treat with opioid for pain control within 7days before registration
10. vomiting and/or more than Gr2 nausea (CTCAE) within 72 hours after registration
11. impossible to record medical diary
12. no prior Crizotinib
13. assessed unsuitable to this study by attending doctor because of any other reason

Related Information

• Primary Sponsor: Goto Koichi
• Source(s) of Monetary Support: Pfizer Investigator Initiated Research funding
• Secondary ID(s): R000020083