UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of combinational effect of Aprepitant on nausea and vomiting induced by chemotherapy (moderate risk) in patients with Gastric Cancer or Colorectal Cancer
Title of the study (Brief title)	Emend
Region	Japan

Condition
Condition	Inoperable advanced/recurrence Gastric Cancer or Colorectal Cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate combinational effect of Aprepitant on nausea and vomiting induced by chemotherapy (moderate risk) in patients with Gastric Cancer or Colorectal Cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	* Frequency of vomiting * Severity of nausea
Key secondary outcomes	* Grading of appetite * Used amount of per-request medication

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group A: * 1st course : Conventional therapy (Palonosetron 0.75 mg i.v. on 1st day + Dexamathasone 9.9 mg i.v. on 1st day, 8 mg p.o. on 2nd day and 3rd day) * 2nd course : Conventional therapy (Palonosetron 0.75 mg i.v. on 1st day + Dexamathasone 4.95 mg i.v. on 1st day, 4 mg p.o. on 2nd day and 3rd day) plus Aprepitant (125 mg p.o. on 1st day, 80 mg p.o. on 2nd day and 3rd day)
Interventions/Control_2	Group B: * 1st course: Conventional therapy (Palonosetron 0.75 mg i.v. on 1st day + Dexamathasone 4.95 mg i.v. on 1st day, 4 mg p.o. on 2nd day and 3rd day) plus Aprepitant (125 mg p.o. on 1st day, 80 mg p.o. on 2nd day and 3rd day) * 2nd course : Conventional therapy (Palonosetron 0.75 mg i.v. on 1st day + Dexamathasone 9.9 mg i.v. on 1st day, 8 mg p.o. on 2nd day and 3rd day)
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) Patient who has Gastric Cancer or Colorectal Cancer receiving FOLFILI, CPT-11 monotherapy, FOLFOX or XELOX regimen (2) Performance Status (ECOG)=0-2
Key exclusion criteria	(1) Patient who has severe liver failure or renal failure (2) Patient who has vomited or provoked nausea in the 24 hours prior to start of chemotherapy (3) Patient who has a factor that induces nausea or vomitting except chemotherapy (brain tumor, obstruction of gastrointestinal tract, active peptic ulcer, brain metastasis et al) (4) Patient who is considered inappropriate as a target patient by a physician-in-charge
Target sample size	100

Research contact person
Name of lead principal investigator	Masashiro Goto
Organization	Osaka Medical College Hospital
Division name	Chemotherapy Center
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
TEL	072-683-1221
Email	in2030@poh.osaka-med.ac.jp

Public contact
Name of contact person	Masahiro Goto
Organization	Osaka Medical College Hospital
Division name	Chemotherapy Cancter
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
TEL	072-683-1221
Homepage URL
Email	in2030@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College Hospital
Institute
Department

Funding Source
Organization	Osaka Medical College Hospital
Organization
Division
Category of Funding Organization	Self funding
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	大阪医科大学付属病院（Osaka Medical College Hospital)

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 02 Month 01 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2012 Year 02 Month 01 Day
Date of closure to data entry	2014 Year 11 Month 01 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 05 Month 28 Day
Last modified on	2017 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009470