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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001951
Receipt No. R000002334
Scientific Title Phase II study of biweekly cetuximab plus irinotecan for unresectable colorectal cancer
Date of disclosure of the study information 2009/05/11
Last modified on 2011/11/09

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Basic information
Public title Phase II study of biweekly cetuximab plus irinotecan for unresectable colorectal cancer
Acronym Phase II study of biweekly cetuximab plus irinotecan for colorectal cancer
Scientific Title Phase II study of biweekly cetuximab plus irinotecan for unresectable colorectal cancer
Scientific Title:Acronym Phase II study of biweekly cetuximab plus irinotecan for colorectal cancer
Region
Japan

Condition
Condition Unresectable colorectal cancer
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Anti tumor effect (objective response)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes disease control rate, duration of progression free survival, overall survival, toxicity, biomarker analysis

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 Biweekly cetuximab plus irinotecan
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 Histological proven colorectal cancer
No KRAS mutation
Measurable lesions according to RECIST criteria
Following previous treatment
refractory to irinotecan
refractory or failure to 5FU and oxaliplatin
Age>20 or older
Expected >2 months survival
Written informed consent from patient
Key exclusion criteria Symptomatic brain metastasis
Wattery diarrhea
Paralytic or mechanical bowel obstruction
confirmed or suspected infection
Severe pulmonary disease (interstitial pneumonia, pulmonary fobrosis, severe emphysematous)
Severe comorbidity (uncontrolable diabetes, heart failure with NYHA 3 or 4, renal failure, liver failure)
Sever neurologic disease
history of irinotecan allergy
past history of treatment with EGFR antibody
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Shitara
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address
TEL
Homepage URL
Email kshitara@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization Other
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
2009 Year 05 Month 11 Day

Related information
URL releasing protocol
Publication of results 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 01 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2010 Year 04 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
2009 Year 05 Month 09 Day
Last modified on
2011 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002334

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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