UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005488 |
|---|---|
| Receipt number | 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 | 2021/05/25 15:54:00 |
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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
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
tmizushima@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Clinical Study Group Osaka Colorectal Cancer Treatment Group
Institute
Department
Personal name
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
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
| 2021 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006513
