UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005071 |
|---|---|
| Receipt number | R000005977 |
| Scientific Title | Study of efficacy and safety of oral neurokinin-1 antagonist, aprepitant for prevention of chemotherapy-induced nausea and vomiting associated with 5-FU/cisplatin chemotherapy in patients with head and neck cancer. |
| Date of disclosure of the study information | 2011/02/15 |
| Last modified on | 2022/02/21 15:57:03 |
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Basic information
Public title
Study of efficacy and safety of oral neurokinin-1 antagonist, aprepitant for prevention of chemotherapy-induced nausea and vomiting associated with 5-FU/cisplatin chemotherapy in patients with head and neck cancer.
Acronym
Effect of aprepitant in patients with head and neck cancer receiving 5-FU/cisplatin chemotherapy.
Scientific Title
Study of efficacy and safety of oral neurokinin-1 antagonist, aprepitant for prevention of chemotherapy-induced nausea and vomiting associated with 5-FU/cisplatin chemotherapy in patients with head and neck cancer.
Scientific Title:Acronym
Effect of aprepitant in patients with head and neck cancer receiving 5-FU/cisplatin chemotherapy.
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of aprepitant 5-days regimen with 5-HT3 receptor antagonist and dexamethasone in patients with head and neck cancer receiving 5-FU/cisplatin chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients with Complete Response (no vomiting and no use of rescue therapy) in overall phase (8 days after administration of cisplatin on day 1)
Key secondary outcomes
1) The proportion of patients with Complete Response in acute phase (days 1 to 4 after administration of cisplatin on day 1) and delayed phase (days 5 to 8 after administration of cisplatin on day 1)
2) The proportion of patients with no vomiting in overall, acute, and delayed phase
3) The frequency of nausea and vomiting
4) Food Intake
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aprepitant 125 mg PO on day 1
Aprepitant 80 mg PO on days 2 to 5
Granisetron 3 mg IV on days 1 to 4
Dexamethasone 8 mg IV on days 1 to 4
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patient is scheduled to receive his/her first course of 5-FU/cisplatin chemotherapy for head and neck cancer
2) Patient has not received highly or moderately emetogenic chemotherapy
3) Performance Status : 0-2
Key exclusion criteria
1) Patient has a serious hepatic insufficiency or renal failure
2) Patient has nausea or vomiting within 24 hours prior to chemotherapy
3) Patient has been treated with antiemetic agents within 48 hours prior to chemotherapy
4) Patient has any illness (e.g. central nervous system tumors, gastrointestinal obstruction, active peptic ulcer, brain metastasis) caused nausea or vomiting except for chemotherapy-induced nausea and vomiting
5) Patient is scheduled to receive radiation therapy to the abdomen
6) Patient is judged inappropriate by the investigator as subject for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kotaro Ishimaru |
Organization
Nagasaki University Hospital
Division name
Department of otolaryngology
Zip code
Address
1-7-1 sakamoto, Nagasaki, Japan
TEL
095-819-7349
kishimar@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Ishimaru |
Organization
Nagasaki University Hospital
Division name
Department of otolaryngology
Zip code
Address
1-7-1 sakamoto, Nagasaki, Japan
TEL
095-819-7349
Homepage URL
kishimar@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of otolaryngology , Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of otolaryngology , Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 15 | 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 | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | 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
| 2011 | Year | 02 | Month | 12 | Day |
Last modified on
| 2022 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005977
