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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006452
Receipt No. 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

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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
Email

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
Email nkiyota@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007590

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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