UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004238 |
|---|---|
| Receipt number | R000005095 |
| Scientific Title | Retrospective study of distributions of FcGRIIa-131 and FcGRIIIa-158 polymorphisms and clinical response to cetuximab in metastatic colorectal cancer (mCRC) |
| Date of disclosure of the study information | 2010/09/30 |
| Last modified on | 2016/02/18 14:26:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Retrospective study of distributions of FcGRIIa-131 and FcGRIIIa-158 polymorphisms and clinical response to cetuximab in metastatic colorectal cancer (mCRC)
Acronym
Fcgamma study in colorectal cancer
Scientific Title
Retrospective study of distributions of FcGRIIa-131 and FcGRIIIa-158 polymorphisms and clinical response to cetuximab in metastatic colorectal cancer (mCRC)
Scientific Title:Acronym
Fcgamma study in colorectal cancer
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To Investigate the distributions of FcGR polymorphisms and their association with clinical response to cetuximab in metastatic colorectal cancer patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparisons according to FcGR polymorphisms for progression-free survival
Key secondary outcomes
Comparisons according to FcGR polymorphisms for response rate and overall survival
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
1)Adenocarcinoma confirmed histologically 2)Unresectable/metastatic colorectal cancer
3)KRAS genotype was examined
4)Baseline CT was done within 28 days from treatment
5)Measurable lesion
6)Treatment including cetuximab after September, 2008
7)5-FU resistant or intolerance
8)Irinotecan resistant or intolerance
9)Oxaliplatin resistant or intolerance
10)More than 20 years old
11)Gathering peripheral blood sample is possible
12)ECOG PS 0-2
13)Organs function is maintained
14)Informed consent by the document
Key exclusion criteria
(1)UGT1A1 genotype is homozygote of *28 or a homozygote of *6 or a double of *28 and *6 (Only cetuximab plus irinotecan therapy)
(2)Serious infection
(3)Drainage is nessesary(pleural effusion, ascites, pericardial effusion)
(4)Intestinal pneumonia or the anamnesis and interstitial pulmonary fibrosis
(5)Serious heart disease
(6)Intestinal tract paralysis or ileus
(7)Serious erethism
(8)Serious complication (diabetes, high blood pressure, hypercalcaemia)
(9)Brain metastasis with symptoms
(10)Repetition cancer
(11)Investigator judged to be inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Yoshino |
Organization
National Cancer Center Hospital East
Division name
Endoscopy & Gastrointestinal Oncology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
+81-4-7133-1111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiraku Fukushima |
Organization
Hokkaido University Hospital
Division name
Department of Cancer Center
Zip code
Address
14-5 Kitaku, Sapporo, Hokkaido
TEL
+81-11-716-1161
Homepage URL
hirakuarata@gmail.com
Sponsor or person
Institute
Study Group about the adequacy of detection method for biomarker in gastrointestinal cancer
Institute
Department
Personal name
Funding Source
Organization
Subsidy for cancer research by Ministry of Health and Welfare
Organization
Division
Category of Funding Organization
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
| 2010 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2009 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
The distributions of FcGRIIa HH/HR/RR and FcGRIIIa VV/VF/FF were 68/30/2% and 4/40/56%, respectively. The absence of LD between FcGRIIa and FcGRIIIa polymorphisms was confirmed (GENEPOP, p=0.526; Linkdis, p=0.146). Now we chase correlation with the clinical response to cetuximab.
Management information
Registered date
| 2010 | Year | 09 | Month | 21 | Day |
Last modified on
| 2016 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005095
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
