UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004993 |
|---|---|
| Receipt number | 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 22:03:05 |
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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
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/
tmoriwak@md.tsukuba.ac.jp
Sponsor or person
Institute
Cancer Chemotherapy Group in Ibaraki Cancer Clinical Epidemiology Study
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005937
