UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016782 |
|---|---|
| Receipt number | 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 | 2025/05/07 13:40:28 |
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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 | Takeda Pharmaceutical Company Limited |
| Middle name | |
| Last name | Takeda Pharmaceutical Company Limited |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Oncology Business Unit
Zip code
103 - 8668
Address
https://www.takeda.com/jp/who-we-are/contact-us/
TEL
06-6204-2111
Japan.ONC.Evidence.Gen@takeda.com
Public contact
Name of contact person
| 1st name | Clinical Trial Information |
| Middle name | |
| Last name | Contact for Clinical Trial Information |
Organization
Takeda Pharmaceutical Company Limited
Division name
Contact for Clinical Trial Information
Zip code
103 - 8668
Address
12-10 Nihonbashi 2-chome Chuo-ku Tokyo Japan
TEL
03-6226-8880
Homepage URL
Japan.ONC.Evidence.Gen@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
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
Non-Profit Organization MINS Institutional Review Board
Address
5-20-9-401 Mita, Minato-ku, Tokyo
Tel
03-6416-1868
Japan.ONC.Evidence.Gen@takeda.com
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
https://www.nature.com/articles/s41591-023-02791-w
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41591-023-02791-w
Number of participants that the trial has enrolled
757
Results
This prespecified exploratory biomarker analysis evaluated the association between ctDNA gene alterations and efficacy outcomes, focusing on a broad panel of gene alterations. OS was prolonged with panitumumab plus modified FOLFOX6 versus bevacizumab plus modified FOLFOX6 in patients with ctDNA that lacked gene alterations in the panel but was similar or inferior with panitumumab in patients with ctDNA that contained any gene alteration in the panel, regardless of tumor sidedness.
Results date posted
| 2023 | Year | 09 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 11 | Day |
Last modified on
| 2025 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019475
