UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010056 |
|---|---|
| Receipt number | R000011749 |
| Scientific Title | Comparison of antiemetic effectiveness and safety of palonosetron and dexamethasone with palonosetron, dexamethasone and aprepitant in patients with lung cancer receiving combination therapy with carboplatin: A phase II randomized study |
| Date of disclosure of the study information | 2013/03/10 |
| Last modified on | 2015/02/18 00:54:34 |
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Basic information
Public title
Comparison of antiemetic effectiveness and safety of palonosetron and dexamethasone with palonosetron, dexamethasone and aprepitant in patients with lung cancer receiving combination therapy with carboplatin: A phase II randomized study
Acronym
Comparison of effectiveness of palonosetron and dexamethasone with palonosetron, dexamethasone and aprepitant in patients with lung cancer
Scientific Title
Comparison of antiemetic effectiveness and safety of palonosetron and dexamethasone with palonosetron, dexamethasone and aprepitant in patients with lung cancer receiving combination therapy with carboplatin: A phase II randomized study
Scientific Title:Acronym
Comparison of effectiveness of palonosetron and dexamethasone with palonosetron, dexamethasone and aprepitant in patients with lung cancer
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 added to palonosetron and dexamethasone in patient with lung cancer receiving 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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients received dexamethasone and palonosetron, and then received carboplatin.
Interventions/Control_2
Patients received dexamethasone, palonosetron and aprepitant, and then received carboplatin.
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
Advanced, metastatic or recurrent NSCLC
Adequate function of the bone marrow, liver and kidney.
PS(ECOG) 0-2
Key exclusion criteria
Patients with severe complications.
Patients with brain metastasis.
Patients with convulsive disorders requiring treatment.
Patients with pleural effusion or ascites requiring treatment.
Patients with gastrointestinal obstruction.
Patients with drug sensitivities.
Patients received antiemetic therapy as below, in the 24 hours before chemotherapy.
5HT3 receptor antagonist, NK1 receptor antagonist, adrenocortical steroid, antidopaminergic agent, phenothiazine
derivative, antihistamine, benzodiazepine
compound.
Pregnant female, nursing mom.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafuimi 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 | Hideki Kusagaya |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
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 | 03 | Month | 10 | 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
| 2013 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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 | 17 | Day |
Last modified on
| 2015 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011749
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
