UMIN-CTR Clinical Trial

Basic information
Public title	An exploratory study of treatment sensitivity and prognostic factors in a Phase III, randomized, controlled study comparing the efficacy and safety of mFOLFOX6 + bevacizumab therapy vs. mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve wild-type RAS(KRAS/NRAS) unresectable advanced or recurrent colorectal cancer
Acronym	Exploratory analysis of biomarkers in PARADIGM study
Scientific Title	An exploratory study of treatment sensitivity and prognostic factors in a Phase III, randomized, controlled study comparing the efficacy and safety of mFOLFOX6 + bevacizumab therapy vs. mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve wild-type RAS(KRAS/NRAS) unresectable advanced or recurrent colorectal cancer
Scientific Title:Acronym	Exploratory analysis of biomarkers in PARADIGM study
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	This study is exploratory analysis of biomarkers to estimate treatment effects of panitumumab and bevacizumab.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the relationship between overall survival (OS) of the main study and mutation of each gene in tumor samples from baseline of the main study
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	mFOLFOX6 + panitumumab
Interventions/Control_2	mFOLFOX6 + bevacizumab
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Patients who are enrolled in the main study and personally provided written consent after adequately explained about the contents of the additional study
Key exclusion criteria	(1)Patients who are determined by the investigator or researchers to be not suitable for participating in the additional study
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroyuki Uetake/Katsuya tsuchihara
Organization	Medical Hospital, Tokyo Medical and Dental University / National Cancer Center
Division name	Department of Surgical Oncology / Division of Translational Research, Exploratory Oncology and Clinical Trial Center
Zip code
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo / 6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL	03-6226-8880
Email	protocol@paradigm-study.jp

Public contact
Name of contact person	1st name Middle name Last name Contact for Clinical Trial Information
Organization	Takeda Pharmaceutical Company Limited
Division name	Contact for Clinical Trial Information
Zip code
Address	12-10 Nihonbashi 2-chome Chuo-ku Tokyo Japan
TEL	03-6226-8880
Homepage URL
Email	protocol@paradigm-study.jp

Sponsor
Institute	Takeda Pharmaceutical Company Limited
Institute
Department

Funding Source
Organization	Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization	Profit organization
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	YES
Study ID_1	JapicCTI-152837
Org. issuing International ID_1	JAPIC
Study ID_2	NCT02394795
Org. issuing International ID_2	clinicaltrials.gov
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 23 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	No longer recruiting
Date of protocol fixation	2015 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date	2015 Year 04 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 11 Day
Last modified on	2017 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019475

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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