UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001838 |
|---|---|
| Receipt number | R000002213 |
| Scientific Title | Phase II study of cetuximab plus irinotecan for unresectable colorectal cancer |
| Date of disclosure of the study information | 2009/04/01 |
| Last modified on | 2011/11/09 13:33:40 |
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Basic information
Public title
Phase II study of cetuximab plus irinotecan for unresectable colorectal cancer
Acronym
Phase II study of cetuximab plus irinotecan for colorectal cancer
Scientific Title
Phase II study of cetuximab plus irinotecan for unresectable colorectal cancer
Scientific Title:Acronym
Phase II study of cetuximab plus irinotecan for colorectal cancer
Region
| Japan |
Condition
Condition
Unresectable advaned or recurrent colorectal cancer
Classification by specialty
| Medicine in general | Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Anti tumor effect of cetuximab plus irinotecan for advanced colorectal cancer who progressed after irinotecan/5-FU/oxaliplatin
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 response, 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
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
Following previous treatment
refractory to irinotecan
refractory or failure to 5FU and oxaliplatin
Age 20 or older
Written informed consent from patient
Key exclusion criteria
Symptomatic brain metastasis
Wartery 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 | Kei Muro |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
Address
, 1-1 Kanokoden, Chikusa-ku, Nagoya 464-0011, Aichi, Japan.
TEL
052-762-6111
Public contact
Name of contact person
| 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 464-0011, Aichi, Japan.
TEL
052-762-6111
Homepage URL
kshitara@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
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
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 | 04 | Month | 01 | 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
| 2008 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | 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 | 04 | Month | 01 | Day |
Last modified on
| 2011 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002213
