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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026054
Receipt No. R000029924
Scientific Title Safety and efficacy of new pressure type infusion instrument VESSEL FUSER (type T) in outpatient cases with colon cancer for home anti-cancer chemotherapy
Date of disclosure of the study information 2017/02/08
Last modified on 2017/08/16

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Basic information
Public title Safety and efficacy of new pressure type infusion instrument VESSEL FUSER (type T) in outpatient cases with colon cancer for home anti-cancer chemotherapy
Acronym VESSEL study
Scientific Title Safety and efficacy of new pressure type infusion instrument VESSEL FUSER (type T) in outpatient cases with colon cancer for home anti-cancer chemotherapy
Scientific Title:Acronym 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
1st name
Middle name
Last name Yukimasa Hatachi
Organization Kobe City Medical center General Hospital
Division name Medical Oncology
Zip code
Address +81-78-302-4321
TEL 078-302-4321
Email yukimasa@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukimasa Hatachi
Organization Kobe City Medical center General Hospital
Division name Medical Oncology
Zip code
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)

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
2017 Year 02 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2016 Year 04 Month 08 Day
Date of IRB
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

Other
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

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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