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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001547
Receipt No. R000001852
Scientific Title Clinical Investigation of Efficacy and Safety in Second-line Bevacizumab treatment combined with FOLFIRI or FOLFOX for metastatic colorectal cancer
Date of disclosure of the study information 2008/12/03
Last modified on 2010/12/02

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Basic information
Public title Clinical Investigation of Efficacy and Safety in Second-line Bevacizumab treatment combined with FOLFIRI or FOLFOX for metastatic colorectal cancer
Acronym Clinical Investigation of Bevacizumab plus FOLFIRI or FOLFOX in previously treated metastatic colorectal cancer (2nd-BV)
Scientific Title Clinical Investigation of Efficacy and Safety in Second-line Bevacizumab treatment combined with FOLFIRI or FOLFOX for metastatic colorectal cancer
Scientific Title:Acronym Clinical Investigation of Bevacizumab plus FOLFIRI or FOLFOX in previously treated metastatic colorectal cancer (2nd-BV)
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Clinical Investigation of Efficacy and Safety in Second-line Bevacizumab treatment combined with FOLFIRI or FOLFOX for metastatic colorectal cancer in Japan
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Response rate, Time to Treatment failure, Adverse events rate, Progression free survival, Overall survival
Key secondary outcomes

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)Histologically confirmed adenocarcinoma in colon cancer, rectal cancer or cecal cancer
2)Unresectable and/or metastatic cancer
3)FOLFIRI+bevacizumab or FOLFOX+bevacizumab treatment in patients with previous chemotherapy
4)Performance status 0-2(ECOG)
Key exclusion criteria 1)Prior bevacizumab administration
2)FOLFIRI+bevacizumab in patients with previous CPT-11-based chemotherapy, or FOLFOX+bevacizumab in patients with previous L-OHP-based chemotherapy
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichinosuke Hyodo
Organization University of Tsukuba
Division name Gastroenterology
Zip code
Address 1-1-1 Tennodai, Tsukuba-shi, Ibaraki-ken, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshikazu Moriwaki
Organization University of Tsukuba
Division name Gastroenterology
Zip code
Address
TEL
Homepage URL http://www.tctg.or.jp/index.html
Email

Sponsor
Institute Tsukuba Cancer Clinical Trial Group
Institute
Department

Funding Source
Organization Tsukuba Cancer Clinical Trial Group
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2008 Year 12 Month 03 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
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 Completed
Date of protocol fixation
2008 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2010 Year 08 Month 01 Day
Date analysis concluded

Other
Other related information No randomazation
Retrospective and Follow-up survey

Management information
Registered date
2008 Year 12 Month 02 Day
Last modified on
2010 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001852

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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