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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006059
Receipt No. R000007173
Scientific Title s-1/cpt-11/cetuximab combination therapy in patients with advanced colorectal kras wild cancer: phase 2 trial
Date of disclosure of the study information 2011/07/29
Last modified on 2011/07/28

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Basic information
Public title s-1/cpt-11/cetuximab combination therapy in patients with
advanced colorectal kras wild cancer: phase 2 trial
Acronym iris/cet combination phase 2 trial
Scientific Title s-1/cpt-11/cetuximab combination therapy in patients with
advanced colorectal kras wild cancer: phase 2 trial
Scientific Title:Acronym iris/cet combination phase 2 trial
Region
Japan

Condition
Condition advanced colorectal kras-wild cancer
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 evaluate safety and efficacy for s-1/cpt-11/cetuximab in patients with advanced colorectal kras-wild cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes response rate
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 ts-1
cpt-11
cetuximab
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
80 years-old >
Gender Male and Female
Key inclusion criteria advanced colorectal kras-wild cancer
Key exclusion criteria double cancer
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name onodera hisashi
Organization st.lukes international hospital
Division name syoukakicenter
Zip code
Address chuuouku akashichou 9-1
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization syoukakicenter jimukyoku
Division name syoukakicenter
Zip code
Address
TEL 03-3541-5151
Homepage URL
Email

Sponsor
Institute shoukakicenter jimukyoku
Institute
Department

Funding Source
Organization gaitounashi
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
2011 Year 07 Month 29 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2011 Year 06 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 08 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

Management information
Registered date
2011 Year 07 Month 28 Day
Last modified on
2011 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007173

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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