UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011363 |
|---|---|
| Receipt number | R000007361 |
| Scientific Title | Phase IIstudy of biweekly FOLFIRI+cetuximab treatment for unresectable KRAS-wild type colorectal cancer |
| Date of disclosure of the study information | 2013/08/03 |
| Last modified on | 2016/10/07 14:45:57 |
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Basic information
Public title
Phase IIstudy of biweekly FOLFIRI+cetuximab treatment for unresectable KRAS-wild type colorectal cancer
Acronym
Phase IIstudy of FOLFIRI+biweekly cetuximab
Scientific Title
Phase IIstudy of biweekly FOLFIRI+cetuximab treatment for unresectable KRAS-wild type colorectal cancer
Scientific Title:Acronym
Phase IIstudy of FOLFIRI+biweekly cetuximab
Region
| Japan |
Condition
Condition
unresectable colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of FOLFIRI+biweekly cetuximab treatment for umresectable colorectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Disease free survival
Overall survival
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
administration of cetuximab biweekly
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
pathologically proven colorectal cancer
Kras wild type
PS; 0-2
untreated case
Key exclusion criteria
severe dysfunction of bone marrow, liver, renal, and cardiac function
no prior radiotherapy, chemotherapy or any molecular targeting therapy for rectal cancer; no other co-existing malignancy or malignancy within the last five years prior to enrollment no severe concurrent medical or psychiatric illness
no a known hypersensitivity to the study drugs
none of the patients were pregnant or lactating.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Maeda |
Organization
Osaka City University Graduate School of Medicine
Division name
Dept of Surgical Oncology
Zip code
Address
1-4-3Asahimachi, Abeno-ku, Osaka, Japan
TEL
06-6645-3838
m1378386@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Maeda |
Organization
Osaka City University Graduate School of Medicine
Division name
Dept of Surgical Oncology
Zip code
Address
1-4-3Asahimachi, Abeno-ku, Osaka, Japan
TEL
06-6645-3838
Homepage URL
m1378386@med.osaka-cu.ac.jp
Sponsor or person
Institute
Dept of Surgical Oncology Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka CIty University
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
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
大阪市立大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 19 | 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
| 2013 | Year | 08 | Month | 03 | Day |
Last modified on
| 2016 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007361
