UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009128 |
|---|---|
| Receipt number | R000010697 |
| Scientific Title | To evaluate the availability of intra-erythrocytic oxaliplatin and plasma oxaliplatin for patients who received oxaliplatin containing adjuvant chemotherapy |
| Date of disclosure of the study information | 2012/10/16 |
| Last modified on | 2012/10/16 10:37:48 |
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Basic information
Public title
To evaluate the availability of intra-erythrocytic oxaliplatin and plasma oxaliplatin for patients who received oxaliplatin containing adjuvant chemotherapy
Acronym
To evaluate the availability of intra-erythrocytic oxaliplatin and plasma oxaliplatin for patients who received oxaliplatin containing adjuvant chemotherapy
Scientific Title
To evaluate the availability of intra-erythrocytic oxaliplatin and plasma oxaliplatin for patients who received oxaliplatin containing adjuvant chemotherapy
Scientific Title:Acronym
To evaluate the availability of intra-erythrocytic oxaliplatin and plasma oxaliplatin for patients who received oxaliplatin containing adjuvant chemotherapy
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the availability of intra-erythrocytic oxaliplatin and plasma oxaliplatin
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Stage II/III colon cancer
(2)Consent has already been obtained about receiving the adjuvant chemotherapy containing oxaliplatin
Key exclusion criteria
(1)Prior chemotherapy including platinum drugs
(2)HBs antigen positive, HCV antibody positive, HIV antibody positive, TPHA positive, and the active infection which needs systemic treatment
(3)History of psychological disease or central nervous system disorders
(4)No intention of cooperating with clinical tests in this study
(5)Current or prospective enrolled in placebo controlled trial for peripheral neuropathy
(6) Other conditions not suitable for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuo Shimada |
Organization
Tokushima University Hospital
Division name
Department of Digestive and Pediatric Surgery
Zip code
Address
50-1 Kuramotocho 2-chome, Tokushima city
TEL
088-631-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohiko Sato |
Organization
Tokushima University Hospital
Division name
Department of Digestive and Pediatric Surgery
Zip code
Address
50-1 Kuramotocho 2-chome, Tokushima city
TEL
088-631-3111
Homepage URL
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2012 | Year | 10 | Month | 16 | 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
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2012 | Year | 10 | Month | 16 | Day |
Last modified on
| 2012 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010697
