UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004579 |
|---|---|
| Receipt number | R000005468 |
| Scientific Title | Phase 1/2 study of cetuximab plus capecitabine in elderly patients with kras-wild type mCRC who have no prior chemotherapy |
| Date of disclosure of the study information | 2011/02/08 |
| Last modified on | 2011/02/08 17:12:42 |
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Basic information
Public title
Phase 1/2 study of cetuximab plus capecitabine in elderly patients with kras-wild type mCRC who have no prior chemotherapy
Acronym
CC with elderly kras-wild type mCRC
Scientific Title
Phase 1/2 study of cetuximab plus capecitabine in elderly patients with kras-wild type mCRC who have no prior chemotherapy
Scientific Title:Acronym
CC with elderly kras-wild type mCRC
Region
| Japan |
Condition
Condition
unresectable metastatic colorectal cancer
Classification by specialty
| Medicine in general | Gastroenterology | Hematology and clinical oncology |
| Geriatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess safety and efficacy when given in combination with cetuximab plus capecitabine for the first-line treatment of unresectable recurrent and/or metastatic kras-wild type elderly CRC patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety/efficacy
Key secondary outcomes
PFS,OS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
capecitabine,cetuximab
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Kras wild type
over 80
no prior chemotherapy
unresectable CRC
PS=0,1
keep good orgun function
Key exclusion criteria
Surgery or irradiation within 4weeks befor trial entry
Uncontrolled comobirity
Active infection
unable to intake
Pulmonary fibrosis, interstital pneumonia
with previous medical history
Target sample size
41
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki MIZUNUMA |
Organization
Cancer institute hospital
Division name
medical oncology
Zip code
Address
3-10-6 ARIAKE. KOTO-KU, TOKYO 135-8550
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasutoshi KUBOKI |
Organization
Cancer institute hospital
Division name
medical oncology
Zip code
Address
TEL
Homepage URL
yasutoshi.kuboki@jfcr.or.jp
Sponsor or person
Institute
Department of medical oncology, Cancer institute hospital, in Japan
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
癌研有明病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | 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
| 2010 | Year | 11 | Month | 17 | Day |
Last modified on
| 2011 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005468
