UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011962 |
|---|---|
| Receipt number | R000013975 |
| Scientific Title | Study of NK1-receptor antagonist; aprepitant for prevention of nausea and emesis in patients receiving chemotherapy with irinotecan for gastric cancer. |
| Date of disclosure of the study information | 2013/10/05 |
| Last modified on | 2017/10/10 08:45:46 |
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Basic information
Public title
Study of NK1-receptor antagonist; aprepitant for prevention of nausea and emesis in patients receiving chemotherapy with irinotecan for gastric cancer.
Acronym
Effect of aprepitant in patient receiving chemotherapy with irinotecan for gastric cancer.
Scientific Title
Study of NK1-receptor antagonist; aprepitant for prevention of nausea and emesis in patients receiving chemotherapy with irinotecan for gastric cancer.
Scientific Title:Acronym
Effect of aprepitant in patient receiving chemotherapy with irinotecan for gastric cancer.
Region
| Japan |
Condition
Condition
Advanced 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 with irinotecan 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 after chemotherapy, acute phase; 0-24hr, delayed phase; 24-120hr].
Key secondary outcomes
1) ratio of patient without emesis.
2) ratio of patient without rescue treatment.
3) ratio of patient without nausea.
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
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)patients receiving first course of chemotherapy with irinotecan for gastric cancer.
2)UGT1A1 genotype: wild or hetero type
3) aged 20 years or more.
4) patents had carried out no adverse effect of prior chemotherapy.
5) 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 chemotherapy
5) patient who was intended radiation therapy
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
Gastroenterologic Surgery
Zip code
Address
13-1, Takara-machi, Kanazawa, Ishikawa 920-8641, Japan
TEL
076-265-2000
oya-ma@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsunobu Oyama |
Organization
Kanazawa University
Division name
Gastroenterologic Surgery
Zip code
Address
13-1, Takara-machi, Kanazawa, Ishikawa 920-8641, Japan
TEL
076-265-2000
Homepage URL
oya-ma@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Gastroenterologic Surgery, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Digestive Disease Support Organization (DDSO)
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 10 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | 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
To investigate the efficacy and safety of aprepitant for prevention of nausea and emesis in patients receiving chemotherapy with irinotecan for gastric cancer.
Management information
Registered date
| 2013 | Year | 10 | Month | 04 | Day |
Last modified on
| 2017 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013975
