UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002165 |
|---|---|
| Receipt number | R000002650 |
| Scientific Title | Cetuximab biomarker study |
| Date of disclosure of the study information | 2009/08/10 |
| Last modified on | 2012/05/02 13:51:46 |
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Basic information
Public title
Cetuximab biomarker study
Acronym
C-MAb BM study
Scientific Title
Cetuximab biomarker study
Scientific Title:Acronym
C-MAb BM study
Region
| Japan |
Condition
Condition
Recurrent or metastatic colorectal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate predictive markers of efficacy and side effects of cetuximab for recurrent or metastatic colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
correlatopn between biomarkers and efficacy and side effects of cetuximab
Key secondary outcomes
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
| Medicine |
Interventions/Control_1
Cetuximab and Irinotecan
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.adenocarcinoma histology
2.primary site: colon or rectum
3.metastatic or recurrent disease
4.EGFR(IHC) positive
5.K-RAS Wild type in case of EGFR negative
6.above 20 y.o.
7. PS 0-1
8. prior chemotherapy with fluoropirimidine, L-OHP, irinotecan
9. no prior tretment with EGFR inhibitors
10. at least one measurable lesion
11. written informed consent form
Key exclusion criteria
1.active synchronous malignancy
2.pregnancy
3.severe psychological disease
4.systemic steroid administration
5.HBV carrier
6.uncontrolled diabetes
7.severe fluid collection
8.bowel obstruction
9.cardiovasucular disease within 3months
10.severe comorbidity
11.active infection
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu Minami |
Organization
Kobe University Hospital
Division name
Medical Oncology
Zip code
Address
7-5-1 Kusunokicho, chu-oku, Kobe, Hyogo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naomi Kiyota |
Organization
Kobe University Hospital
Division name
Medical Oncology
Zip code
Address
7-5-1 Kusunokicho, chu-oku, Kobe, Hyogo, Japan
TEL
Homepage URL
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
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
| 2009 | Year | 08 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 04 | Day |
Last modified on
| 2012 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002650
