UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026054 |
|---|---|
| Receipt number | 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 18:40:45 |
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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
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
yukimasa@kcho.jp
Sponsor or person
Institute
Kobe City Medical center General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029924
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
