UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006578 |
|---|---|
| Receipt number | R000007790 |
| Scientific Title | Pilot study of ceramide cream for the skin toxicity of cetuximab in advanced colorectal cancer. |
| Date of disclosure of the study information | 2011/10/20 |
| Last modified on | 2012/12/28 11:31:34 |
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Basic information
Public title
Pilot study of ceramide cream for the skin toxicity of cetuximab in advanced colorectal cancer.
Acronym
Pilot study of ceramide cream for the skin toxicity of cetuximab in advanced colorectal cancer.
Scientific Title
Pilot study of ceramide cream for the skin toxicity of cetuximab in advanced colorectal cancer.
Scientific Title:Acronym
Pilot study of ceramide cream for the skin toxicity of cetuximab in advanced colorectal cancer.
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy of ceramide cream for the sikn toxicity of cetuximab use for advanced colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
efficacy for skin toxicity
Key secondary outcomes
time to efficacy
safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
ceramide cream
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)Patients with skin toxicity of cetuximab uncontrolled with coventional therapy.
2) PS(ECOG) 0 or 1.
3) Patients who can use ceramide cream.
4) Patients who can respond to uestinnaire.
5) Agree with take the pictures of skin toxicity.
6) Life expectancy 3months over.
7)Written informed concent.
Key exclusion criteria
1) Other causes occureing skin toxicity.
2) inappropriate for the study.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nakamura |
Organization
Aizawa Hospital
Division name
Aizawa comprehensive cancer center
Zip code
Address
Honjo 2-5-1, Matsumoto city, Nagano, Japan
TEL
+81-263-33-8600
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Aizawa Hospital
Division name
Aizawa comprehensive cancer center
Zip code
Address
Honjo 2-5-1, Matsumoto city, Nagano, Japan
TEL
0263-33-8600
Homepage URL
geka-dr7@ai-hosp.or.jp
Sponsor or person
Institute
Aizawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Aizawa Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2011 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
| 2012 | Year | 11 | Month | 15 | Day |
Date trial data considered complete
| 2012 | Year | 11 | Month | 15 | Day |
Date analysis concluded
| 2012 | Year | 11 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 20 | Day |
Last modified on
| 2012 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007790
