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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005071
Receipt No. 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 2015/03/24

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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
Email 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
Email kishimar@nagasaki-u.ac.jp

Sponsor
Institute Department of otolaryngology , Nagasaki University Hospital
Institute
Department

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
Email

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
2015 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005977

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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