UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004021 |
|---|---|
| Receipt number | 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 15:14:23 |
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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
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
Sponsor or person
Institute
Division of Upper Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004822
