UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006059 |
|---|---|
| Receipt number | 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 13:57:42 |
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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
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
Sponsor or person
Institute
shoukakicenter jimukyoku
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007173
