UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031621 |
|---|---|
| Receipt number | R000036095 |
| Scientific Title | Retrospective analysis of randomized phase II trial (WJOG6210G) of FOLFIRI with either panitumumab or bevacizumab as second-line treatment in patients with KRAS wild metastatic colorectal cancer refractory to oxaliplatin and bevacizumab to evaluate the association of survival time and treatment efficacy (early tumor shrinkage, depth of response and best overall response) at each arm |
| Date of disclosure of the study information | 2018/03/07 |
| Last modified on | 2021/09/08 11:00:04 |
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Basic information
Public title
Retrospective analysis of randomized phase II trial (WJOG6210G) of FOLFIRI with either panitumumab or bevacizumab as second-line treatment in patients with KRAS wild metastatic colorectal cancer refractory to oxaliplatin and bevacizumab to evaluate the association of survival time and treatment efficacy (early tumor shrinkage, depth of response and best overall response) at each arm
Acronym
Retrospective analysis for predictive factor of FOLFIRI+Pmab vs FOLFIRI+BV as second-line for colorectal cancer
Scientific Title
Retrospective analysis of randomized phase II trial (WJOG6210G) of FOLFIRI with either panitumumab or bevacizumab as second-line treatment in patients with KRAS wild metastatic colorectal cancer refractory to oxaliplatin and bevacizumab to evaluate the association of survival time and treatment efficacy (early tumor shrinkage, depth of response and best overall response) at each arm
Scientific Title:Acronym
Retrospective analysis for predictive factor of FOLFIRI+Pmab vs FOLFIRI+BV as second-line for colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association of survival time (progression-free survival, overall survival) and treatment efficacy (early tumor shrinkage, depth of response and best overall response) at each arm (FOLFIRI+BV, FOLFIRI+Pmab) for metastatic colorectal cancer as second-line chemotherapy.
Basic objectives2
Others
Basic objectives -Others
To explore the predictive factor of treatment
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the association of survival time (progression-free survival, overall survival) and treatment efficacy (early tumor shrinkage, depth of response and best overall response) at each arm (FOLFIRI+BV, FOLFIRI+Pmab) for metastatic colorectal cancer as second-line chemotherapy.
Key secondary outcomes
To evaluate the association of known data of ligand protein level and period of BV treatment during first-line chemotherapy.
To evaluate the association of treatment efficacy and patient characteristics.
To evaluate the association of survival time and patient characteristics.
To evaluate the association of survival time and known data of ligand protein level.
To evaluate the association of survival time and VEGF-D which is measured by using residual sample, treatment efficacy and VEGF-D, and patient characteristics and VEGF-D.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were enrolled in WJOG6210G study
Key exclusion criteria
None
Target sample size
117
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Izawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
Address
2-16-1, Sugao, Miyamake-ku, Kawasaki
TEL
044-977-8111
n2izawa@marianna-u.ac.jp
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
Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2018 | Year | 03 | Month | 07 | 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To explore the predictive factor of treatment
Management information
Registered date
| 2018 | Year | 03 | Month | 07 | Day |
Last modified on
| 2021 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036095
