UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002031 |
|---|---|
| Receipt number | 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 09:28:34 |
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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
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002470
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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