UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059294 |
|---|---|
| Receipt number | R000067823 |
| Scientific Title | A biomarker study associated with a randomized, prospective phase II trial comparing the efficacy and safety of mFOLFOX6 plus cetuximab (q2w) versus mFOLFOX6 plus bevacizumab as first-line treatment for unresectable right-sided colon cancer with RAS/BRAF wild-type |
| Date of disclosure of the study information | 2025/10/06 |
| Last modified on | 2025/10/05 17:10:00 |
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Basic information
Public title
A biomarker study associated with a randomized, prospective phase II trial comparing the efficacy and safety of mFOLFOX6 plus cetuximab (q2w) versus mFOLFOX6 plus bevacizumab as first-line treatment for unresectable right-sided colon cancer with RAS/BRAF wild-type
Acronym
A biomarker study associated with a randomized, prospective phase II trial comparing the efficacy and safety of mFOLFOX6 plus cetuximab (q2w) versus mFOLFOX6 plus bevacizumab as first-line treatment for unresectable right-sided colon cancer with RAS/BRAF wild-type
Scientific Title
A biomarker study associated with a randomized, prospective phase II trial comparing the efficacy and safety of mFOLFOX6 plus cetuximab (q2w) versus mFOLFOX6 plus bevacizumab as first-line treatment for unresectable right-sided colon cancer with RAS/BRAF wild-type
Scientific Title:Acronym
A biomarker study associated with a randomized, prospective phase II trial comparing the efficacy and safety of mFOLFOX6 plus cetuximab (q2w) versus mFOLFOX6 plus bevacizumab as first-line treatment for unresectable right-sided colon cancer with RAS/BRAF wild-type
Region
| Japan |
Condition
Condition
unresectable colon cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
As a specified clinical research study, this project aims to investigate the relationship between treatment efficacy or resistance mechanisms and the DNA methylation status as well as gene mutation profiles measured using ctDNA in patients with right-sided colon cancer who received mFOLFOX6 plus bevacizumab or mFOLFOX6 plus cetuximab as first-line chemotherapy.
Basic objectives2
Others
Basic objectives -Others
As a specified clinical research study, this project aims to investigate the relationship between treatment efficacy or resistance mechanisms and the DNA methylation status as well as gene mutation profiles measured using ctDNA in patients with right-sided colon cancer who received mFOLFOX6 plus bevacizumab or mFOLFOX6 plus cetuximab as first-line chemotherapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study investigates the association between treatment efficacy (ORR, DCR, ETS, mTS, PFS, and OS) and tumor classification (LMCC or HMCC).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a primary tumor located in the right colon (cecum, ascending colon, or transverse colon) histologically diagnosed as colorectal adenocarcinoma.
Patients with metastatic colorectal cancer (Stage IV according to the UICC TNM classification) or postoperative recurrent colorectal cancer.
Confirmed RAS (KRAS and NRAS) wild-type status based on genetic testing.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Presence of at least one measurable target lesion on imaging, as defined by RECIST version 1.1.
Key exclusion criteria
Presence of a confirmed BRAF V600E mutation.
Patients with brain metastases or those with a strong clinical suspicion of brain metastases.
Patients with effusions requiring intervention, such as pleural effusion, ascites, or pericardial effusion.
Patients with a history of interstitial lung disease, or those with extensive findings suggestive of such conditions on CT imaging.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Chikashi |
| Middle name | |
| Last name | Ishioka |
Organization
JR Sendai Hospital
Division name
Medical Oncology
Zip code
980-0022
Address
1-1-5, Itsutsubashi, Aoba-ku, Sendai-shi
TEL
022-266-9671
chikashi@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Ouchi |
Organization
Tohoku University Hospital
Division name
Medical Oncology
Zip code
981-8574
Address
1-1, Seiryo-cho, Aoba-ku
TEL
022-717-8543
Homepage URL
kota.ouchi.b3@tohoku.ac.jp
Sponsor or person
Institute
JR Sendai Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Hospital Institutional Review Board
Address
1-1, Seiryo-cho, Aoba-ku
Tel
022-718-0461
crb-hosp@grp.tohoku.ac.jp
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
| 2025 | Year | 10 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Explore the association between the efficacy of the treatment administered in this trial (response rate, disease control rate, early tumor reduction rate, maximum tumor reduction rate, progression-free survival, and overall survival) in each of the classified LMCC and HMCC groups.
By comparing DNA methylation status and gene mutation data obtained from blood samples collected before protocol treatment with data obtained from blood samples collected on day 1 of the 3rd cycle of protocol treatment and at the time of protocol treatment discontinuation, we will elucidate temporal changes in the epigenome and genome and investigate resistance mechanisms.
We will evaluate the objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and disease control rate (DCR) based on the presence or absence of each genetic abnormality (gene mutation, bTMB and MSI, gene rearrangement, copy number alteration) obtained from blood samples (ctDNA) before and after protocol treatment. This will help us understand the relationship with treatment efficacy and explore resistance mechanisms.
Management information
Registered date
| 2025 | Year | 10 | Month | 05 | Day |
Last modified on
| 2025 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067823
