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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016782
Receipt No. R000019475
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
Date of disclosure of the study information 2015/03/23
Last modified on 2017/06/14

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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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