UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017997 |
|---|---|
| Receipt number | 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 10:11:38 |
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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
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
morisem@med.nagoya-u.ac.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020083
