UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018412 |
|---|---|
| Receipt number | R000021317 |
| Scientific Title | Research on biomarkers in "A randomized phase II study to investigate the deepness of response of FOLFOXIRI plus cetuximab (Erbitux) versus FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors" |
| Date of disclosure of the study information | 2015/07/27 |
| Last modified on | 2020/07/21 10:29:59 |
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Basic information
Public title
Research on biomarkers in "A randomized phase II study to investigate the deepness of response of FOLFOXIRI plus cetuximab (Erbitux) versus FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors"
Acronym
JACCRO CC-13AR
Scientific Title
Research on biomarkers in "A randomized phase II study to investigate the deepness of response of FOLFOXIRI plus cetuximab (Erbitux) versus FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors"
Scientific Title:Acronym
JACCRO CC-13AR
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the correlativity of a prognosis and the clinical response on the reported biomarkers or new ones between FOLFOXIRI plus cetuximab and FOLFOXIRI plus bevacizumab as the first-line therapy in advanced colorectal cancer patients with RAS wild-type tumors.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between the reported biomarkers or outcome
and clinical response.
Key secondary outcomes
Correlation between the new biomarkers or outcome
and clinical response.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
FOLFOXIRI+/-Bevacizumab (To 12 courses)
5-FU+Levofolinate+/-Bevacizumab (From 13 courses)
Bevacizumab 5mg/kg/bi-weekly
Irinotecan 150mg/m2/bi-weekly
Oxaliplatin 85mg/m2/bi-weekly
Levofolinate 200mg/m2/bi-weekly
5-FU 2400mg/m2/bi-weekly
Interventions/Control_2
FOLFOXIRI+/-Cetuximab (To 12 courses)
5-FU+Levofolinate+/-Cetuximab (From 13 courses)
Cetuximab (first time) 400 mg/m2/week
Cetuximab (after 2nd time) 250 mg/m2/week
Irinotecan 150mg/m2/bi-weekly
Oxaliplatin 85mg/m2/bi-weekly
Levofolinate 200mg/m2/bi-weekly
5-FU 2400mg/m2/bi-weekly
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 who are registered in JACCRO CC-13 study (UMIN000018217) and eligible to this research.
(1) Approved to supply the section for this research by IRB.
(2) Written informed consent.
Key exclusion criteria
(1) Patients who are regarded as inadequate for study enrollment by investigators.
(2) Patients who refuse to supply the section.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Sunakawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL
044-977-8111
y.suna0825@gmail.com
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Fujii |
Organization
Japan Clinical Cancer Research Organization
Division name
Office
Zip code
104-0061
Address
1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-5579-9882
Homepage URL
masashi.fujii@gioncology.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization
Institute
Department
Personal name
Funding Source
Organization
Japan Clinical Cancer Research Organization
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Liquid Genomics
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Clinical Cancer Research Organization Institutional Review Board
Address
7F Ginza Wing Bil.,1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
Tel
03-5579-9882
jaccro@jaccro.or.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
聖マリアンナ医科大学（神奈川県）他
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 27 | 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
227
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 | 07 | Month | 03 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 24 | Day |
Last modified on
| 2020 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021317
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
