UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004310 |
|---|---|
| Receipt number | R000005154 |
| Scientific Title | Efficacy of mFOLFOX6 with bebacizumab or cetuximab based on K-ras status for unresectable hepatic metastasis of colorectal cancer |
| Date of disclosure of the study information | 2010/10/04 |
| Last modified on | 2016/04/02 09:31:54 |
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Basic information
Public title
Efficacy of mFOLFOX6 with bebacizumab or cetuximab based on K-ras status for unresectable hepatic metastasis of colorectal cancer
Acronym
Efficacy of mFOLFOX6 with bebacizumab or cetuximab based on K-ras status for unresectable hepatic metastasis of colorectal cancer
Scientific Title
Efficacy of mFOLFOX6 with bebacizumab or cetuximab based on K-ras status for unresectable hepatic metastasis of colorectal cancer
Scientific Title:Acronym
Efficacy of mFOLFOX6 with bebacizumab or cetuximab based on K-ras status for unresectable hepatic metastasis of colorectal cancer
Region
| Japan |
Condition
Condition
Unresectable hepatic metastasis of colorectal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify efficacy of mFOLFOX6 with bebacizumab or cetuximab based on K-ras status for unresectable hepatic metastasis of colorectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The ratio of R0 resection or clinical CR
Key secondary outcomes
Safety, The ratio of R0 hepatic resection, overall response rate, pathological response rate, progression free survival, 2-year survival rate, Compliance of initial regimen, relative dose intensity
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
mFOLFOX6+bev or mFOLFOX6+cet
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. colorectal cancer histologically confirmed
2. K-ras status confirmed
3. unresectable hepatic metastasis
4. Liver-specific metastasis or resectable extrahepatic metastasis
5. adequate bone marrow, hepatic, and renal function
Key exclusion criteria
1. Brain metastasis, brain tumor
2. symptomatic cerebrovascular disease
3. active bleeding
4. uncontrolled hypertention
etc.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Etsuro Hatano |
Organization
Kyoto University
Division name
Dept of Hepatobiliarypancreatic and transplantation surgery
Zip code
Address
54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL
075-751-3608
etsu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kojiro Nakamura |
Organization
Kyoto University
Division name
Dept of Hepatobiliarypancreatic and transplantation surgery
Zip code
Address
54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL
075-751-3608
Homepage URL
shiryou@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Other 20 hospitals
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 04 | 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
Main results already published
Date of protocol fixation
| 2010 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 02 | Day |
Last modified on
| 2016 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005154
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/04/02 | 実施計画書_ver3.5_20110815.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2016/04/02 | 登録適格性確認票_K-ras_BevCet_Ver2.5.doc |
| Research case data | |
|---|---|
| Registered date | File name |
| 2016/04/02 | CRF：治癒切除不能肝転移BevCet(5)_ver3.5.doc |
Single case data URL
Value
https://center6.umin.ac.jp/ice/5154
