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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005488
Receipt No. R000006513
Scientific Title Examination of Effectiveness, safety, of Cetuximab as 1st-line treatment for KRAS wild type colorectal cancer.
Date of disclosure of the study information 2011/04/25
Last modified on 2016/07/06

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Basic information
Public title Examination of Effectiveness, safety, of Cetuximab as 1st-line treatment for KRAS wild type colorectal cancer.
Acronym Examination of Effectiveness, safety, of Cetuximab as 1st-line treatment for KRAS wild type colorectal cancer.
Scientific Title Examination of Effectiveness, safety, of Cetuximab as 1st-line treatment for KRAS wild type colorectal cancer.
Scientific Title:Acronym Examination of Effectiveness, safety, of Cetuximab as 1st-line treatment for KRAS wild type colorectal cancer.
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Retrospectively evaluate the efficacy and safety of cetuximab as 1st-line treatment for metastatic colorectal cancer .
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression-free survival, Overall survival, Safety profile, Conversion rate of nonresectable liver metastases to resectable

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) Patient who has histologically colorectal cancer and KRAS wild type.
2) Patient who was treated by Cetuximab as 1st-line for Kras wild type colorectal cancer.
Key exclusion criteria Patients who are inadequate by investigator's decision.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuya Sakata
Organization Higashiosaka City General Hospital
Division name Surgery
Zip code
Address 1-1-1 minamiyasuityo sakai-ku sakai city Osaka
TEL 06-6781-5101
Email sakata-kazu@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Masataka Ikeda Tsunekazu Mizushima
Organization Multicenter Clinical Study Group Osaka
Division name Colorectal Cancer Treatment Group
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565-0871,Japan
TEL 06-6879-3251
Homepage URL
Email tmizushima@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Multicenter Clinical Study Group Osaka Colorectal Cancer Treatment Group
Institute
Department

Funding Source
Organization None
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
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
2011 Year 04 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Response rate
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 Main results already published
Date of protocol fixation
2011 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Progression-free survival
Overall survival
Safety profile
Conversion rate of nonresectable liver metastases to resectable

Management information
Registered date
2011 Year 04 Month 22 Day
Last modified on
2016 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006513

Research Plan
Registered date File name
2016/07/06 KRAS野生型の進行・再発結腸・直腸癌に対する初回治療としてのセツキシマブ療法の有効性と安全性の検討.zip

Research case data specifications
Registered date File name

Research case data
Registered date File name


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