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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011962
Receipt No. 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

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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
Email 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
Email oya-ma@staff.kanazawa-u.ac.jp

Sponsor
Institute Gastroenterologic Surgery, Kanazawa University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013975

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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