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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004993
Receipt No. R000005937
Scientific Title Clinical research of the prediction of clinical outcome in patients with metastatic colorectal cancer treated with cetuximab
Date of disclosure of the study information 2011/02/01
Last modified on 2014/02/03

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Basic information
Public title Clinical research of the prediction of clinical outcome in patients with metastatic colorectal cancer treated with cetuximab
Acronym IBACET study
Scientific Title Clinical research of the prediction of clinical outcome in patients with metastatic colorectal cancer treated with cetuximab
Scientific Title:Acronym IBACET study
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether KRAS/BRAF status and/or cancer related proteins expression could have a predictive/prognostic value in patients treated with cetuximab.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Progression-free survival and Overall survival
Key secondary outcomes Response rate, Grade 3 and more adverse events rate of interest to cetuximab

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) Histological confirmation of colorectal cancer
2) To receive cetuximab alone or cetuximab combination therapy between July 2008 and December 2009
3) To stored in tissue sections of primary or metastatic lesions
Key exclusion criteria 1) Unable to assess the efficacy of cetuximab treatment
2) Other conditions not suitable for this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichinosuke Hyodo
Organization Tsukuba University Hospital
Division name Gastroenterology
Zip code
Address 2-1-1 Amakubo, Tsukuba-shi, Ibaraki-ken, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshikazu Moriwaki
Organization Tsukuba University Hospital
Division name Gastroenterology
Zip code
Address
TEL
Homepage URL http://www.ekigaku-ibaraki.jp/science/
Email tmoriwak@md.tsukuba.ac.jp

Sponsor
Institute Cancer Chemotherapy Group in Ibaraki Cancer Clinical Epidemiology Study
Institute
Department

Funding Source
Organization Ibaraki Cancer Clinical Epidemiology Study
Organization
Division
Category of Funding Organization Local Government
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 筑波大学附属病院(茨城県)、日立総合病院(茨城県)、茨城県立中央病院(茨城県)、龍ヶ崎済生会病院(茨城県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 01 Day

Related information
URL releasing protocol http://www.ekigaku-ibaraki.jp/science/
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The 9th Annual Meeting of Japanese Society of Medical Oncology
KRAS and BRAF mutations as predictive/prognostic factors in patients with metastatic colorectal cancer treated with cetuximab
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
2010 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In previous cetuximab trial reports, predictive marker for response were as follows: KRAS/BRAF mutations, high expression of alternative EGFR ligands, such epiregulin, amphiregulin, insulin growth factor 1, and insulin growth factor receptor.

Management information
Registered date
2011 Year 02 Month 01 Day
Last modified on
2014 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005937

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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