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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031233
Receipt No. R000035663
Scientific Title A clinical study of CapeOX+Cetuximab as first line therapy in patents with KRAS/BRAF wild type metastatic colorectal cancer (A pooled analysis of FLEET and FLEET2 study)
Date of disclosure of the study information 2018/03/01
Last modified on 2018/02/09

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Basic information
Public title A clinical study of CapeOX+Cetuximab as first line therapy in patents with KRAS/BRAF wild type metastatic colorectal cancer
(A pooled analysis of FLEET and FLEET2 study)
Acronym A pooled analysis of FLEET and FLEET2 study
Scientific Title A clinical study of CapeOX+Cetuximab as first line therapy in patents with KRAS/BRAF wild type metastatic colorectal cancer
(A pooled analysis of FLEET and FLEET2 study)
Scientific Title:Acronym A pooled analysis of FLEET and FLEET2 study
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of CapeOX+Cetuximab as first line therapy in patient with KRAS/BRAF wild type for metaststic colorectal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression free survival

Base
Study type Others,meta-analysis etc

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients treated by CapeOx+Cetuximab
in FLEET and FLEET2 study
Key exclusion criteria nane
Target sample size 65

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name shigeyoshiiwamoto
Organization Aichi medical University
Division name Cancer center
Zip code
Address YazakoKarimata 1-1 Nagakute, Aichi, JAPAN
TEL 0561-62-3311
Email iwamoto.shigeyoshi.168@mail.aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name shigeyoshiiwamoto
Organization Aichi medical University
Division name Cancer center
Zip code
Address YazakoKarimata 1-1 Nagakute, Aichi, JAPAN
TEL 0561-62-3311
Homepage URL
Email iwamoto.shigeyoshi.168@mail.aichi-med-u.ac.jp

Sponsor
Institute The nonprofit organization
Epidemiological & Clinical Research Organization.
Institute
Department

Funding Source
Organization The nonprofit organization
Epidemiological & Clinical Research Organization.
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
2018 Year 03 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 03 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 A pooled analysis of FLEET and FLEET2 study

Management information
Registered date
2018 Year 02 Month 09 Day
Last modified on
2018 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035663

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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