UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of new pressure type infusion instrument VESSEL FUSER (type T) in outpatient cases with colon cancer for home anti-cancer chemotherapy
Title of the study (Brief title)	VESSEL study
Region	Japan

Condition
Condition	colon cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of new pressure type infusion instrument VESSEL FUSER (type T) in outpatient cases with colon cancer for home anti-cancer chemotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A cross-comparative analysis of VESSEL FUSER (type T) with conventional type (Safety, QOL, filling ability of drug, safety of drug flow, injecting time, priming time, compatibility to other instruments)
Key secondary outcomes	Improvement of patient Quality of life Reduction in nursing work Reduction in liquid medicine filling time Cost reduction

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
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	Device,equipment
Interventions/Control_1	one time
Interventions/Control_2	forty-six hours
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 had newly diagnosed and histologically confirmed colorectal cancer 2. Patients were age 20 years or older 3. Eastern Cooperative Oncology Group performance status of 0-2 4. Patients receive chemotherapy including FOLFOX or FOLFIRI regimen using pressure type pump in outpatient setting. 5. Adequate hematologic, hepatic and renal function as follows: Neutrophil count 1,500/mm^3or higher Haemoglobin level 9.0g/dl or higher Platelet count 100,000/mm^3 or higher Serum Total bilirubin level 1.0x the upper limit of normal or lower Serum aspartate aminotransferase (AST) levels no higher than 1.5 the ULN Serum alanine aminotransferase (ALT) levels no higher than 1.5 the ULN Serum creatinine level no higher than 1.5 the ULN Or Creatinine clearance 50ml/min or higher 6. All patients provided written informed consent.
Key exclusion criteria	1. Patients with active infection 2. Patients with severe pulmonary disease 3. Patients with uncontrolled heart disease 4. Patients for whom it's difficult to handle a instrument
Target sample size	40

Research contact person
Name of lead principal investigator	Yukimasa Hatachi
Organization	Kobe City Medical center General Hospital
Division name	Medical Oncology
Address	+81-78-302-4321
TEL	078-302-4321
Email	yukimasa@kcho.jp

Public contact
Name of contact person	Yukimasa Hatachi
Organization	Kobe City Medical center General Hospital
Division name	Medical Oncology
Address	+81-78-302-4321
TEL	078-302-4321
Homepage URL
Email	yukimasa@kcho.jp

Sponsor
Institute	Kobe City Medical center General Hospital
Institute
Department

Funding Source
Organization	Toray Industries Inc.
Organization
Division
Category of Funding Organization	Profit organization
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	2017 Year 02 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 08 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 06 Month 30 Day

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

Management information
Registered date	2017 Year 02 Month 08 Day
Last modified on	2017 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029924