UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009483 |
|---|---|
| Receipt number | R000011144 |
| Scientific Title | Phase II study of cetuximab plus 5-FU/LV for unresectable colorectal cancer |
| Date of disclosure of the study information | 2012/12/05 |
| Last modified on | 2021/06/14 12:28:59 |
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Basic information
Public title
Phase II study of cetuximab plus 5-FU/LV for unresectable colorectal cancer
Acronym
Phase II study of cetuximab plus 5-FU/LV for unresectable colorectal cancer
Scientific Title
Phase II study of cetuximab plus 5-FU/LV for unresectable colorectal cancer
Scientific Title:Acronym
Phase II study of cetuximab plus 5-FU/LV for unresectable colorectal cancer
Region
| Japan |
Condition
Condition
Unresectable 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 and safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
disease control rate, progression free survival, overall survival, toxicity, QOL
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
cetuximab plus 5-FU/LV
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 unresectable colorectal cancer
KRAS wild
Measurable lesions according to RECIST criteria
Following previous treatment
- refractory to 5-FU
- failure or refractory or intolerant of irinotecan
- refractory or failure to oxaliplatin
Adequate interval from previous treatments
Adequate organ function
Age of 20 years or older
ECOG performance status 0-2
Expected more than 8 weeks survival
Written informed consent from patient
Key exclusion criteria
Symptomatic brain metastasis
Sever wattery diarrhea
Paralytic or mechanical bowel obstruction
Confirmed or suspected infection
Severe pulmonary disease
Severe comorbidity
Pregnant or possibly pregnant, and nursing women
Sever neurologic disease
Receiving atazanavir sulfate
Past history of monoclonal antibody sever allergy
Past history of 5-FU/LV sever allergy
Past history of treatment with Anti-EGFR
Other conditions not suitable for this study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Muro |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
TEL
0527626111
h.taniguchi@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ura |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
TEL
052-762-6111
Homepage URL
tura@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center 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
ACCH IRB
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.
Tel
052-762-6111
yterasima@aichi-cc.jp
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
| 2012 | Year | 12 | Month | 05 | 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
| 2012 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 05 | Day |
Last modified on
| 2021 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011144
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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