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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010635
Receipt No. 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

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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
Email 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/
Email jaccro@jaccro.or.jp

Sponsor
Institute Japan Clinical Cancer Research Organization
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012437

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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