UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031233 |
|---|---|
| Receipt number | 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 19:19:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
iwamoto.shigeyoshi.168@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
The nonprofit organization
Epidemiological & Clinical Research Organization.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035663
