UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of NK1-receptor antagonist; aprepitant for prevention of nausea and emesis in patients receiving chemotherapy with irinotecan for gastric cancer.
Title of the study (Brief title)	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	Sachio Fushida
Organization	Kanazawa University
Division name	Gastroenterologic Surgery
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	Katsunobu Oyama
Organization	Kanazawa University
Division name	Gastroenterologic Surgery
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 09 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000013975