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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017997
Receipt No. R000020083
Scientific Title Efficacy and safety of oral granisetron and dexamethasone for crizotinib-induced nausea and vomiting in patient with non-small cell lung cancer (NSCLC)
Date of disclosure of the study information 2015/06/23
Last modified on 2017/06/22

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Basic information
Public title Efficacy and safety of oral granisetron and dexamethasone for crizotinib-induced nausea and vomiting in patient with non-small cell lung cancer (NSCLC)
Acronym CROWN study
Scientific Title Efficacy and safety of oral granisetron and dexamethasone for crizotinib-induced nausea and vomiting in patient with non-small cell lung cancer (NSCLC)
Scientific Title:Acronym 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
1st name
Middle name
Last name Koichi Goto
Organization National Cancer Center Hospital East
Division name Department of Thoracic Oncology
Zip code
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
1st name
Middle name
Last name Masahiro Morise
Organization Nagoya University Graduate School of Medicine, Nagoya, Japan
Division name Department of Respiratory medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 05 Month 26 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000020083

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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