UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004936 |
|---|---|
| Receipt number | R000005877 |
| Scientific Title | Palonosetron+Aprepitant+Dexamethasone for moderately emetic chemotherapy induced nausea and voimiting-Phase II study- |
| Date of disclosure of the study information | 2011/01/24 |
| Last modified on | 2018/06/14 10:41:23 |
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Basic information
Public title
Palonosetron+Aprepitant+Dexamethasone for moderately emetic chemotherapy induced nausea and voimiting-Phase II study-
Acronym
Palonosetron+Aprepitant+Dexamethasone for moderately emetic chemotherapy induced nausea and voimiting
Scientific Title
Palonosetron+Aprepitant+Dexamethasone for moderately emetic chemotherapy induced nausea and voimiting-Phase II study-
Scientific Title:Acronym
Palonosetron+Aprepitant+Dexamethasone for moderately emetic chemotherapy induced nausea and voimiting
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of Palonosetron+ Aprepitant + Dexamethasone in moderately emetic CINV in lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Complete response rate in 1st course of chemotherapy
Key secondary outcomes
Complete response rate in any course of chemotherapy
Complete control rate
Time to treatment failure
QOL analysis
Toxicity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aprepitant: 125mg po. 1-1.5 hr. prior to chemotherapy on Day1
Palonosetron:0.75mg iv. prior to chemotherapy on Day1
Dexamethasone: 4.95mg iv. 30 min. prior to chemotherapy on Day 1, 4mg po. on Day 2-3.
Interventions/Control_2
Granisetron or Ondansetron:1A iv. prior to chemotherapy on Day1
Dexamethasone: 9.9mg iv. 30 min. prior to chemotherapy on Day 1, 8mg po. on Day 2-3.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically proven Lung cancer
2)Moderately or Highly emetic chemotherapy
3)Patient receiving moderately emetic chemotherapy defined by NCCN guideline 2009, ver 1.
3) Written IC.
Key exclusion criteria
1)MEC administration except Day 1.
2)Radiation therapy
3)Contraindication of Dexamethasone
4)Symptomatic brain meta
5)Hypersensitivity for Palonosetron, Aprepitant, Dexamethasone
6)Vomiting episode prior to chemotherapy with 24 hours
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohisa Yoshizawa |
Organization
Niigata University Medical and Dental Hospital
Division name
Bioscience Medical Research Center
Zip code
Address
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL
025-227-2517
hy0522@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohisa Yoshizawa |
Organization
Niigata University Medical and Dental Hospital
Division name
Bioscience Medical Research Center
Zip code
Address
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL
025-227-2517
Homepage URL
hy0522@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata Lung Cancer Treatment Group
Institute
Department
Personal name
Funding Source
Organization
Niigata Foundation of the Promotion of Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
新潟肺癌治療研究会参加施設
新潟大学医歯学総合病院
新潟県立がんセンター新潟病院
鶴岡市立荘内病院
新潟市民病院
新潟県立新発田病院
佐渡総合病院
南部郷総合病院
厚生連長岡中央綜合病院
厚生連三条総合病院
厚生連刈羽郡総合病院
長岡赤十字病院
厚生連豊栄病院
済生会新潟第二病院
国立病院機構西新潟中央病院
新潟県立中央病院
新潟県立柿崎病院
燕労災病院
上越総合病院
新潟県立吉田病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 24 | Day |
Last modified on
| 2018 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005877
