UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006452 |
|---|---|
| Receipt number | R000007590 |
| Scientific Title | Phase II trial of bi-weekly cetuximab for recurrent or metastatic colorectal cancer |
| Date of disclosure of the study information | 2011/11/01 |
| Last modified on | 2019/05/09 20:26:20 |
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Basic information
Public title
Phase II trial of bi-weekly cetuximab for recurrent or metastatic colorectal cancer
Acronym
B-CMAb Phase II
Scientific Title
Phase II trial of bi-weekly cetuximab for recurrent or metastatic colorectal cancer
Scientific Title:Acronym
B-CMAb Phase II
Region
| Japan |
Condition
Condition
recurrent or metastatic colorectal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
to assess the efficacy and safety of bi-weekly cetuximab for recurrent or metastatic colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Disease control rate
Key secondary outcomes
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
bi weekly 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) histologically proven adenocarcinoma
2) KRAS wild type
3) refractory to irinotecan
4) refractory and intolerable to fluoropyrimidines
5) refractory and intolerable to oxaliplatin
6) at least one measurable lesion
7) over 20 years old
8) PS 0-2
9) without prior radiation and chemotherapy within 2 weeks
10) good organ function
11) estimated survival over 8 weeks
12) written informed consent
Key exclusion criteria
1) without active other malignancy
2) without active infection
3) without active brain metastasis
4) without severe pulmonary diseases
5) without HBs Ag
6) without severe heart diseases
7) without pregnancy
8) without prior EGFR inhibitors
9) without other medical condition unacceptable for entry
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu Minami |
Organization
Kobe University Hospital
Division name
Medical Oncology and Hematology
Zip code
Address
7-5-1 Chuo-Ku, Kobe, Hyogo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University Hospotal
Division name
Medical Oncology and Hematology
Zip code
Address
TEL
Homepage URL
nkiyota@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 02 | Day |
Last modified on
| 2019 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007590
