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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004021
Receipt No. R000004822
Scientific Title Study of oral neurokinin-1 antagonist, aprepitant for the prevention of nausea and vomiting in patients receiving chemotherapy with irinotecan alone or combination of irinotecan plus cisplatin for unresectable gastric cancer
Date of disclosure of the study information 2010/08/09
Last modified on 2010/08/08

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Basic information
Public title Study of oral neurokinin-1 antagonist, aprepitant for the prevention of nausea and vomiting in patients receiving chemotherapy with irinotecan alone or combination of irinotecan plus cisplatin for unresectable gastric cancer
Acronym Effect of aprepitant in patients receiving chemotherapy with irinotecan alone or combination of irinotecan plus cisplatin
Scientific Title Study of oral neurokinin-1 antagonist, aprepitant for the prevention of nausea and vomiting in patients receiving chemotherapy with irinotecan alone or combination of irinotecan plus cisplatin for unresectable gastric cancer
Scientific Title:Acronym Effect of aprepitant in patients receiving chemotherapy with irinotecan alone or combination of irinotecan plus cisplatin
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of aprepitant for prevention of nausea and vomiting in patients receiving chemotherapy with irinotecan alone or combination of irinotecan plus cisplatin for unresectable gastric cancer by double-blined-control method
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Overall complete response (no vomiting and no rescue treatment) [Time Frame: During and post chemotherapy (0-120hr)]
2) Complete response acute/delayed phase [Time Frame: During and post chemotherapy (0-120hr)]
3) Overall complete protection (no vomiting, no rescue treatment and no significant nausea (VAS<25mm)) [Time Frame: During and post chemotherapy (0-120hr)]
4) Complete protection acute/delayed phase [Time Frame:During and post chemotherapy(0-120hr)]
Key secondary outcomes 1) Proportion of patients without vomiting and nausea, frequency of vomiting, no rescue treatment, and time to first vomiting or first rescue treatment [Time Frame: During and post chemotherapy (0-120hr)]
2) Evaluation of nausea, vomiting and appetite loss using CTCAE, VAS scale and Functional Living index-Emesis (FLIE) scale[Time Frame: During and post chemotherapy (0-120hr)]
3) Investigation of potential factors predisposing patients to nausea and vomiting (e.g.,patient's sense of anxiety)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1) Aprepitant: 125mg P.O./day on day1 followed by 80mg P.O./day on day2 and 3
2) Dexamethasone: 3.3mg I.V./body on day1-3
3) Granisetron: 40ug I.V./kg on day1
Interventions/Control_2 1) Placebo: Placebo capsules P.O. on day1-3
2) Dexamethasone: 6.6mg I.V./body on day1-3
3) Granisetron: 40ug I.V./kg on day1
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Pathologic diagnosis of gastric cancer
2) Possible state of oral intake
3) Unresectable gastric cancer
4) Performance status is 0 to 2
5) Patients who are older than 20 years at entry
6) WBC > 3,000/mm3, Platelets > 10,000/mm3
7) Patients who understand the study contents and give informed consents by themselves
Key exclusion criteria 1) Known hypersensitivity to any component of study regimen
2) Patients receiving pimozide or atazanavir sulfate
3) Patients with active infectious diseases
4) Patients with active interstitial pneumonia or pulmonary fibrosis
5) Patients with large quantity of pleural effusion or ascites
6) Patients with frequent diarrhea (watery)
7) Patients with jaundice
8) Patients with ileus
9) Pregnant or lactating women
10) Patients who are regarded in-eligible by the doctor who participates in this study
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroto Miwa
Organization Hyogo College of Medicine
Division name Division of Upper Gastroenterology, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Junji Tanaka
Organization Hyogo College of Medicine
Division name Division of Upper Gastroenterology, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
Homepage URL
Email

Sponsor
Institute Division of Upper Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
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 兵庫医科大学病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 09 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
2010 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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
2010 Year 08 Month 09 Day
Last modified on
2010 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004822

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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