UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004175 |
|---|---|
| Receipt number | R000004929 |
| Scientific Title | Study of oral neurokinin-1 antagonist, aprepitant for prevention of nausea and emesis in patients receiving chemotherapy including cisplatin for gastric cancer. |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2013/01/28 22:07:17 |
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Basic information
Public title
Study of oral neurokinin-1 antagonist, aprepitant for prevention of nausea and emesis in patients receiving chemotherapy including cisplatin for gastric cancer.
Acronym
Effect of aprepitant in patient recieving chemotherapy including cisplatin for gastric cancer.
Scientific Title
Study of oral neurokinin-1 antagonist, aprepitant for prevention of nausea and emesis in patients receiving chemotherapy including cisplatin for gastric cancer.
Scientific Title:Acronym
Effect of aprepitant in patient recieving chemotherapy including cisplatin for gastric cancer.
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of aprepitant for prevention of nausea and emesis in patients receiving chemotherapy involving cisplatin for gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of complete response (defined as no emesis and no rescue treatment). [Time Frame: overall; 0-120hr(during and post chemotherapy), acute phase;0-24hr, delayed phase 24-120hr] .
Key secondary outcomes
1) ratio of patient without emesis.
2) ratio of patient without resque treatment.
3) ratio of patient without neusea.
4) time to first emesis.
5) evaluation of volume of meal intake.
6) evaluation of QOL with Functional Living index-Emesis (FLIE) scale.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We use three antiemetic drugs (aprepitant/granisetron/dexamethasone) for this trial.
aprepitant: oral administration, 125mg; 1 hour before chemotherapy on day1, 80mg; after breakfast on day2-3.
granisetron: 0.04mg/kg; intravenous administration, before chemotherapy on day1.
dexamethasone: 9.9mg; intravenous administration, before chemotherapy on day1, 8mg; oral administration, day 2-3.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) chemotherapy-naive ( including cisplatin, dose intensity; more than 10mg/week) patients with gastric cancer.
2) aged 20 years or more.
3) patents had undergone treatment with high emetic risk and moderate emetic risk chemotherapy prior to this study
4) written informed consent from the patients.
Key exclusion criteria
1) patients with serious hepatic insufficiency or renal failure.
2) patients with emesis within 24 hours before first administrating of cisplatin.
3) patients who were administered antiemetic drugs within 48 hours before first administrating of cisplatin.
4) patients with emetic factor except for chmotherapy
5) patient who was intended radiation therapy
6) patients judged inappropriate for this study by physicians.
7) patients who received Pimozide.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sachio Fushida |
Organization
Kanazawa University
Division name
Division of gastroenterologic surgery
Zip code
Address
13-1, Takara-machi, Kanazawa, Ishikawa 920-8641, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kanazawa University
Division name
Division of gastroenterologic surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Division of gastroenterologic surgery, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Division of gastroenterologic surgery, Kanazawa University
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
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
| 2010 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Addition of aprepitant to standard antiemetic
therapy was effective in gastric cancer patients
undergoing treatment with cisplatin and S-1.
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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 08 | Day |
Last modified on
| 2013 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004929
