UMIN-CTR Clinical Trial

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

Contact us.