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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002031
Receipt No. R000002470
Scientific Title Exploratory analysis of predictive and prognostic biomarkers in the randomized phase III study of FOLFOX plus bevacizumab versus FOLFIRI plus bevacizumab for metastatic colorectal cancer (WJOG4407GTR)
Date of disclosure of the study information 2009/06/02
Last modified on 2016/02/25

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Basic information
Public title Exploratory analysis of predictive and prognostic biomarkers in the randomized phase III study of FOLFOX plus bevacizumab versus
FOLFIRI plus bevacizumab for metastatic colorectal cancer (WJOG4407GTR)
Acronym Exploratory analysis of biomarkers in FOLFOX+bevacizumab vs FOLFIRI+bevacizumab for m-CRC
Scientific Title Exploratory analysis of predictive and prognostic biomarkers in the randomized phase III study of FOLFOX plus bevacizumab versus
FOLFIRI plus bevacizumab for metastatic colorectal cancer (WJOG4407GTR)
Scientific Title:Acronym Exploratory analysis of biomarkers in FOLFOX+bevacizumab vs FOLFIRI+bevacizumab for m-CRC
Region
Japan

Condition
Condition metastatic colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the clinicopathological features and biomarkers for predictive and prognostic values in patients with metastatic colorectal cancer treated with either FOLFOX+bevacizumab or FOLFIRI+bevacizumab
Basic objectives2 Others
Basic objectives -Others Translational study: Evaluation of predictive and prognostic factors
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1) To correlate micro vascular density (MVD) and expression of VEGF-A in the tumor specimens with response rates (RR), progression free survival (PFS) and over all survival (OS).
2) To correlate expressions of various genes and k-Ras gene status in the tumor specimens with RR, PFS and OS.
3) To correlate the values of angiogenesis-related growth factors in plasma with RR, PFS and OS.
4) To correlate the profiles of glycoconjugates in plasma with RR, PFS and OS.
Key secondary outcomes Not applicable

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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Those who participate in the WJOG4407G and give informed consent to the current study are qualified.
Key exclusion criteria Not applicable
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Tsurutani
Organization Kinki University School of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-2 Ohnohigashi, Osakasayama, Osaka 589-8511 Japan
TEL 072-366-022
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

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
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
2009 Year 06 Month 02 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
2009 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2015 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the clinicopathological features and biomarkers for predictive and prognostic values in patients with metastatic colorectal cancer treated with either FOLFOX+bevacizumab or FOLFIRI+bevacizumab

Management information
Registered date
2009 Year 06 Month 02 Day
Last modified on
2016 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002470

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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