UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010635 |
|---|---|
| Receipt number | R000012437 |
| Scientific Title | Research on biomarkers in cetuximab containing combination therapies for patients with KRAS wild-type metastatic colorectal cancer |
| Date of disclosure of the study information | 2013/05/07 |
| Last modified on | 2019/03/08 10:08:00 |
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Basic information
Public title
Research on biomarkers in cetuximab containing combination therapies for patients with KRAS wild-type metastatic colorectal cancer
Acronym
JACCRO CC-05/CC-06 AR research
Scientific Title
Research on biomarkers in cetuximab containing combination therapies for patients with KRAS wild-type metastatic colorectal cancer
Scientific Title:Acronym
JACCRO CC-05/CC-06 AR research
Region
| Japan |
Condition
Condition
metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Retrospective exploratory reseach on the reported biomarkers (DNA, RNA, and protein expression) or new ones (DNA, RNA, and microRNA) using the paraffin-embedded section of tumor tissue confirmed EGFR-positive and wild-type of KRAS gene before the first-line treatment
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 (EGFR expression, ligand expression to EGFR, BRAF, PI3K, and PTEN expression) or new ones (DNA microarray, analysis of microRNA expression, and DNA SNP analysis) and the response to cetuximab containing combination therapies
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
NO
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
cetuximab loading dose 400mg/m2, 250mg/m2/week
L-OHP 85mg/m2/biweekly
levofololinate 200mg/m2/biweekly
5-FU bolus 400 mg/m2/biweekly
5-FU continuous 2,400 mgm2/biweekly
/
Interventions/Control_2
cetuximab loding dose 400 mg/m2, 250 mg/m2/week
L-OHP 75-130 mg/m2/tri-weekly
S-1 80-120 mg/day, day1-14
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
(1) Patients who are registered in JACCRO CC-05 study (UMIN000004197) or in JACCRO CC-06 study (UMIN000007022) and started protocol therapy
(2) Remaining the paraffin-embedded section of tumor tissue
(3) Approved to supply the section for this research by IRB
(4) Getting the informed consent from the patient, in the case of death or disappearance, approval of IRB and the representative of hospital must be taken
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
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wataru Ichikawa |
Organization
National Defense Medical College Hospital
Division name
Department of Clinical Oncology
Zip code
Address
3-2 Namiki, Tokorozawa-shi, Saitama 359-8513, Japan
TEL
04-2995-1511
wataru@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Fujii |
Organization
Japan Clinical Cancer Research Organization
Division name
Office
Zip code
Address
1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-5579-9893
Homepage URL
http://www.jaccro.com/
jaccro@jaccro.or.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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 06 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 06 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 06 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 02 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012437
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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