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Recruitment status Terminated
Unique ID issued by UMIN UMIN000004826
Receipt No. R000005717
Scientific Title Randomized crossover trial of Granisetron/Dexamethasone/Aprepitant versus Palonosetron/Dexamethasone/Aprepitant for the prevention of nausea and vomiting in patients receiving receiving Cisplatin containing chemotherapy for head and neck cancer
Date of disclosure of the study information 2011/01/06
Last modified on 2015/01/13

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Basic information
Public title Randomized crossover trial of Granisetron/Dexamethasone/Aprepitant versus Palonosetron/Dexamethasone/Aprepitant for the prevention of nausea and vomiting in patients receiving receiving Cisplatin containing chemotherapy for head and neck cancer
Acronym Randomized crossover trial of Granisetron/Dexamethasone/Aprepitant versus Palonosetron/Dexamethasone/Aprepitant for the prevention of nausea and vomiting in patients receiving receiving Cisplatin containing chemotherapy for head and neck cancer
Scientific Title Randomized crossover trial of Granisetron/Dexamethasone/Aprepitant versus Palonosetron/Dexamethasone/Aprepitant for the prevention of nausea and vomiting in patients receiving receiving Cisplatin containing chemotherapy for head and neck cancer
Scientific Title:Acronym Randomized crossover trial of Granisetron/Dexamethasone/Aprepitant versus Palonosetron/Dexamethasone/Aprepitant for the prevention of nausea and vomiting in patients receiving receiving Cisplatin containing chemotherapy for head and neck cancer
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 antiemetic efficacy and safety of Palonosetron and Granisetron in combination with Dexamethasone and Aprepitant in patients receiving Cisplatin containing chemotherapy for head and neck cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes the proportion of patients with a Complete Protection during the overall phase(0-120 h postchemotherapy), the proportion of patients with a Complete Response during the overall phase
Key secondary outcomes 1)the proportion of patients with a Complete Protection during
the acute phase (0-24 h postchemotherapy) and the delayed
phase (24-120 h postchemotherapy)
2)the proportion of patients with a Complete Response during the overall phase and the acute phase and the delayed phase
3)the proportion of patients with a Complete Control during the overall phase and the acute phase and the delayed phase
4)the proportion of patients without nausea
5)the proportion of patients without emesis
6)time to treatment failure
7)safety

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Aprepitant is administered orally at 125 mg/body 1 hour or 1 hour and half before Cisplatin administration. On day 2 and 3, Aprepitant is administrated orally at 80 mg/body.
Granisetron 40 ug/body and Dexamethasone 12.3 mg/body are
administered intravenously 30 min before Cisplatin administration. On day 2 and 3, Granisetron 40 ug/body and Dexamethasone 6.6 mg/body are administrated.
Interventions/Control_2 Aprepitant is administered orally at 125 mg/body 1 hour or 1 hour and half before Cisplatin administration. On day 2 and 3, Aprepitant is administrated orally at 80 mg/body.
Palonosetron 0.75 mg/body and Dexamethasone 12.3 mg/body are
administered intravenously 30 min before Cisplatin administration. On day 2 and 3, Dexamethasone 6.6 mg/body are administrated.
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) histologically or cytologically confirmed head and neck cancer
2) stage III-IV head and neck cancer
3) without prior treatment
4) age: >=20 and <75
5) patients who are scheduled to receive high emetogenic chemotherapy (Cisplatin >=60 mg/m2)
6) sufficient function of important organs
a)WBC: >=3,000/mm3
b)AST: <100 IU/L
c)ALT: <100 IU.L
d)Ccr: >=60 ml/min/body
7) Performance Statues: 0-1(ECOG)
8) written informed consent
Key exclusion criteria 1) with seizure disorder needing anticonvulsants unless clinically stable
2) with vomiting, retching, or grade 2 or higher nausea according to
CTCAE
3) with QTc prolongation by electrocardiography (QTc: >470 msec)
4) with severe allergy to Palonosetron, Granisetron, Aprepitant and Dexamethasone
5) pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant
6) receiving an antiemetic drug
7) receiving pimozide (orap)
8) with history of mental disorder or treating it at the moment
9) doctor's decision not to be registered to this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiko Oridate
Organization Yokohama City University Graduate School of Medicine
Division name Department of Biology and Function in the Head and Neck
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama,236-0004
TEL 045-787-2687
Email noridate@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiko Oridate
Organization Yokohama City University Graduate School of Medicine
Division name Department of Biology and Function in the Head and Neck
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama,236-0004
TEL 045-787-2687
Homepage URL
Email noridate@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine
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
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 横浜市立大学附属病院(神奈川県)、横浜市立大学附属市民総合医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 06 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 Terminated
Date of protocol fixation
2010 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2014 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 06 Day
Last modified on
2015 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005717

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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