UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018215 |
|---|---|
| Receipt number | R000020275 |
| Scientific Title | Study of the efficacy of hepatic arterial infusion therapy (modified Circadian chronotherapy) for unresectable colorectal cancer liver metastasis |
| Date of disclosure of the study information | 2015/07/06 |
| Last modified on | 2015/07/06 15:51:50 |
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Basic information
Public title
Study of the efficacy of hepatic arterial infusion therapy (modified Circadian chronotherapy) for unresectable colorectal cancer liver metastasis
Acronym
Study of the efficacy of hepatic arterial infusion therapy (modified Circadian chronotherapy) for unresectable colorectal cancer liver metastasis
Scientific Title
Study of the efficacy of hepatic arterial infusion therapy (modified Circadian chronotherapy) for unresectable colorectal cancer liver metastasis
Scientific Title:Acronym
Study of the efficacy of hepatic arterial infusion therapy (modified Circadian chronotherapy) for unresectable colorectal cancer liver metastasis
Region
| Japan |
Condition
Condition
Metastatic liver cancer from colon and rectum
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of hepatic arterial infusion therapy (modified Circadian chronotherapy) for unresectable colorectal cancer liver metastasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
Key secondary outcomes
Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hepatic infusion therapy will be performed.
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.It has been confirmed that it is histologically colon and rectum cancer
2.Diagnosis of stage 4 has been confirmed liver metastases in the diagnostic imaging
3.There is no distant metastasis other than liver, lung, and peritoneal dissemination
4.More than 20yr
5.for registration before tumor organ function within two weeks, it meets the following criteria. Incidentally, if the inspection result within that period there are a plurality and adopting those registered most recently, is not performed transfusion, administration of hematopoietic factors preparations building within two weeks before the test date When measurement
white blood cell number 4000/mm3 or more 12000/mm3 less than
neutrophil number 2000/mm3 or more
platelet count 10.0x4/m3 or more
hemoglobin 9.0g/dl or more
total bilirubin 2.0mg /dl or less
AST. ALT. 200U/L or less
than 1.5 times the serum creatinine facility reference value upper limit
6.there is no clinically problem of the electrocardiogram within registration before 4 weeks
7.The Eastern Cooperative Oncology Group(ECOG) Performance Status =0-1
8.received a sufficient explanation for the study content, written consent of the person has been obtained
Key exclusion criteria
Patient other than the above
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Takeda |
Organization
Yokohama City University Hospital
Division name
Gastroenterological surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City, Japan
TEL
045-787-2800
kazutake@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Takeda |
Organization
Yokohama City University Hospital
Division name
Gastroenterological surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City, Japan
TEL
045-787-2800
Homepage URL
kazutake@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 06 | Day |
Last modified on
| 2015 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020275
