UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010018 |
|---|---|
| Receipt number | R000011725 |
| Scientific Title | Antiemetic effectiveness and safety of aprepitant in patients with lung cancer receiving combination therapy with carboplatin. |
| Date of disclosure of the study information | 2013/02/13 |
| Last modified on | 2013/02/11 22:41:07 |
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Basic information
Public title
Antiemetic effectiveness and safety of aprepitant in patients with lung cancer receiving combination therapy with carboplatin.
Acronym
Antiemetic effectiveness of aprepitant in patients recieving combination therapy with carboplatin
Scientific Title
Antiemetic effectiveness and safety of aprepitant in patients with lung cancer receiving combination therapy with carboplatin.
Scientific Title:Acronym
Antiemetic effectiveness of aprepitant in patients recieving combination therapy with carboplatin
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the antiemetic effect of aprepitant in patient with lung cancer recieving combination therapy with carboplatin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
antiemetic effect
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In initial treatment, patients are randomly allocated to receive newly antiemetic therapy with aprepitant or to recieve existing antiemetic therapy. In second treatment, all patients are received aprepitant.
Interventions/Control_2
In initial treatment, patients are randomly allocated to receive newly antiemetic therapy with aprepitant or to recieve existing antiemetic therapy. In second treatment, all patients are received aprepitant.
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
Pathologically confirmed inoperable stage IIIB or stage IV NSCLC
Adequate function of the bone marrow, liver and kidney.
Patients who can give a precise answer to a questionnaire about antiemetic effect.
Key exclusion criteria
Patients with severe complications.
Patients with nausea and vomitting in the 24 hours before chemotherapy.
Patients received antiemetic therapy in the 48 hours before chemotherapy.
Patients with a risk of vomitting for other reasons. (active peptic ulcer and gastrointestinal obstruction, etc)
Target sample size
134
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1 Handayama, Hamamatsu, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1 Handayama, Hamamatsu, Japan
TEL
Homepage URL
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 02 | Month | 13 | 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
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 12 | Day |
Last modified on
| 2013 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011725
