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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031621
Receipt No. 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 2018/04/12

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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
Email 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
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 12 Day
Last follow-up date
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
2018 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036095

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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