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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002165
Receipt No. R000002650
Scientific Title Cetuximab biomarker study
Date of disclosure of the study information 2009/08/10
Last modified on 2012/05/02

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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
Email

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
Email

Sponsor
Institute Kobe University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002650

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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