UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061783 |
|---|---|
| Receipt number | R000070701 |
| Scientific Title | A Biomarker Study of AREG/EREG Expression as Predictive Markers of Treatment Efficacy in Patients with RAS Wild-Type Unresectable Advanced or Recurrent Colorectal Cancer Treated with mFOLFOX6 plus Panitumumab |
| Date of disclosure of the study information | 2026/06/03 |
| Last modified on | 2026/06/03 15:56:05 |
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Basic information
Public title
A Study Investigating Whether AREG/EREG Expression Can Predict the Effectiveness of mFOLFOX6 Plus Panitumumab Therapy in Patients with RAS Wild-Type Unresectable Advanced or Recurrent Colorectal Cancer
Acronym
AREG/EREG CRC Treatment Prediction Study
Scientific Title
A Biomarker Study of AREG/EREG Expression as Predictive Markers of Treatment Efficacy in Patients with RAS Wild-Type Unresectable Advanced or Recurrent Colorectal Cancer Treated with mFOLFOX6 plus Panitumumab
Scientific Title:Acronym
AREG/EREG-Pmab Study
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical utility of AREG and EREG protein expression levels as predictive biomarkers for the therapeutic efficacy of panitumumab in patients with unresectable RAS wild-type colorectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival in patients with unresectable advanced or recurrent RAS wild-type colorectal cancer treated with mFOLFOX6 plus panitumumab, stratified by high and low AREG and EREG protein expression
Key secondary outcomes
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were enrolled in the PARADIGM trial at 197 institutions in Japan between March 1, 2015 and July 31, 2017, and for whom colorectal cancer tissue specimens obtained before the initiation of mFOLFOX6 plus bevacizumab or mFOLFOX6 plus panitumumab therapy were available.
Key exclusion criteria
Patients whom the investigator considers inappropriate as study participants.
Target sample size
561
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Oki |
Organization
Kyushu University Hospital
Division name
Department of Advanced Medicine and Innovative Technology
Zip code
812-8582
Address
3-1-1 Maedashi Higashiku, Fukuoka
TEL
092-642-5992
oki.eiji.857@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Nambara |
Organization
Kyushu University Hospital
Division name
Department of Gastrointestinal Surgery II
Zip code
812-8582
Address
3-1-1 Maedashi Higashiku, Fukuoka
TEL
092-642-5466
Homepage URL
nanbara36@gmail.com
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Roche Diagnostics K.K.
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
Kyushu University Medical District Institutional Review Board for Observational Studies
Address
3-1-1 Maedashi Higashiku, Fukuoka
Tel
092-642-5082
ijkseimei@jimu.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT02394795
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
jRCTs031180246
Org. issuing International ID_2
Japan Registry of Clinical Trials
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational biomarker study using archived tumor specimens and existing clinical data from patients with unresectable advanced or recurrent RAS wild-type colorectal cancer enrolled in the PARADIGM trial. No new patient recruitment, treatment intervention, randomization, or blinding will be performed in this study. AREG/EREG protein expression will be evaluated using archived tumor specimens and integrated with existing clinical data to analyze its association with PFS and OS.
Management information
Registered date
| 2026 | Year | 06 | Month | 03 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070701
