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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004310
Receipt No. 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

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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
Email 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
Email shiryou@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email

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
URL(English) https://upload.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


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