UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015914 |
|---|---|
| Receipt number | R000018521 |
| Scientific Title | Additional research on biomarkers in "Phase II study of cetuximab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer (JACCRO CC-08) " |
| Date of disclosure of the study information | 2014/12/12 |
| Last modified on | 2016/11/15 13:46:57 |
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Basic information
Public title
Additional research on biomarkers in "Phase II study of cetuximab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer (JACCRO CC-08) "
Acronym
JACCRO CC-08AR
Scientific Title
Additional research on biomarkers in "Phase II study of cetuximab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer (JACCRO CC-08) "
Scientific Title:Acronym
JACCRO CC-08AR
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prospective exploratory reseach on the reported biomarkers (EGFR S492R) using the plasma in the metastatic colorectal cancer patients who are registered in JACCRO CC-08 study, and confirmed wild-type of KRAS gene by the paraffin-embedded section of tumor tissue. In addition, DNA of the rest performs the measurement in Cancer Panel.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Tumor-related gene variation analysis using plasma free DNA
Key secondary outcomes
The measurement in Cancer Panel
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Collecting blood 16mL at the time of before JACCRO CC-08 protocol treatment, 8 weeks after protocol treatment, and PD.
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 who are registered in JACCRO CC-08 study. (UMIN000010638)
(1) Approved to supply the section for this research by IRB. (2) Getting the informed consent from the patient.
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
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wataru Ichikawa |
Organization
Showa University Fujigaoka Hospital
Division name
Division of Medical Oncology
Zip code
Address
1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa, 227-8501 Japan
TEL
045-971-1151
wataru@med.showa-u.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
03-5579-9882
Homepage URL
cc08ar.dc@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
| 2014 | Year | 12 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 11 | Day |
Last modified on
| 2016 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018521
