UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008318 |
|---|---|
| Receipt number | R000006107 |
| Scientific Title | Effect of additional aprepitant on palonosetron and dexamethasone for prevention of moderately emetogenic chemotherapy-induced nausea and vomiting in patients with lung cancer: clinical phase II study |
| Date of disclosure of the study information | 2012/07/02 |
| Last modified on | 2012/07/02 13:13:55 |
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Basic information
Public title
Effect of additional aprepitant on palonosetron and dexamethasone for prevention of moderately emetogenic chemotherapy-induced nausea and vomiting in patients with lung cancer: clinical phase II study
Acronym
Effect of additional aprepitant on palonosetron and dexamethasone for prevention of moderately emetogenic chemotherapy-induced nausea and vomiting in patients with lung cancer: clinical phase II study
Scientific Title
Effect of additional aprepitant on palonosetron and dexamethasone for prevention of moderately emetogenic chemotherapy-induced nausea and vomiting in patients with lung cancer: clinical phase II study
Scientific Title:Acronym
Effect of additional aprepitant on palonosetron and dexamethasone for prevention of moderately emetogenic chemotherapy-induced nausea and vomiting in patients with lung cancer: clinical phase II study
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of additional apreptant to palonosetron and dexamethasone for prevention of moderately emetogenic chemotherapy-induced nausea and vomiting in patients with lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Complete Response (CR) rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-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
Palonosetoron+Dexamethasone
Interventions/Control_2
Palonosetoron+Aprepitant+Dexamethasone
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)No prior chemotherapy
2)Patient receiving combination chemotherapy with CBDCA and moderately emetogenic anticancer drugs
7)Written IC.
Key exclusion criteria
1)vomiting within 24h before first chemotherapy
2)continuatory use of severely or moderately emetogenic anticancer drugs after Day 2
3)concurrent radiotherapy
4) Severe complications
5)Symptomatic brain meta
6)Hypersensitivity for PaIonosetron, Aprepitant, Dexamethasone
7) Other patients who are unfit for the study as determined by the attending physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Ishii |
Organization
Dokkyo Medical University
Division name
Department of Pulmonary Medicine and Clinical Immunology
Zip code
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Ishii |
Organization
Dokkyo Medical University
Division name
Department of Pulmonary Medicine and Clinical Immunology
Zip code
Address
TEL
Homepage URL
ishiiysk@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 07 | Month | 02 | 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
| 2011 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | 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
| 2012 | Year | 07 | Month | 02 | Day |
Last modified on
| 2012 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006107
