UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of oral granisetron and dexamethasone for crizotinib-induced nausea and vomiting in patient with non-small cell lung cancer (NSCLC)
Title of the study (Brief title)	CROWN study
Region	Japan

Condition
Condition	Non-small cel lung cancer
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of a double combination of oral granisetron plus dexamethasone, as standard preventive care for moderate emetic chemotherapy, for crizotinib-induced nausea and vomiting in patient with ALK-positive NSCLC.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complete response rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	granisetron plus dexamethasone by oral administration
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with ALK positive NSCLC 2) Patients with starting crizotinib treatment 3) Patients with 20 years old or older 4) Patients with ECOG Performance Status 0-2 5) Written informed concent
Key exclusion criteria	1) Patients with symptomatic CNS metastases. 2) Documented history of severe autoimmune disease required systemic steroids. 3) Patients with digestive disease associated with symptom of nausea, vomiting and appetite loss
Target sample size	30

Research contact person
Name of lead principal investigator	Koichi Goto
Organization	National Cancer Center Hospital East
Division name	Department of Thoracic Oncology
Address	6-5-1 Kashiwa, Chiba 277-8577, Japan.
TEL	04-7133-1111
Email	kgoto@east.ncc.go.jp

Public contact
Name of contact person	Masahiro Morise
Organization	Nagoya University Graduate School of Medicine, Nagoya, Japan
Division name	Department of Respiratory medicine
Address	65 Tsurumai cho, Nagoya, Aichi, Japan
TEL	052-744-2111
Homepage URL
Email	morisem@med.nagoya-u.ac.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Pfizer Inc
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 23 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 05 Month 26 Day
Anticipated trial start date	2015 Year 06 Month 23 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 21 Day
Last modified on	2017 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020083